Acetaminophen / Hydrocodone Oral Solution
- Brand(s)
- Hycet, Lortab, Zamicet
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Pharmaceutical Associates, Inc. (2014-10-22)
- Oldest Current Product
- 1994-08-16
- License(s)
- ANDA
- RxNORM
- ORAL SOLUTION\ACETAMINOPHEN:HYDROCODONE
- FDAOB
- ORAL\SOLUTION\ACETAMINOPHEN: HYDROCODONE BITARTRATE
- SPL Active
- ORAL\SOLUTION\ACETAMINOPHEN: HYDROCODONE BITARTRATE
ORAL\SYRUP\ACETAMINOPHEN: HYDROCODONE BITARTRATE - SPL Moiety
- ORAL\SOLUTION\ACETAMINOPHEN: HYDROCODONE
ORAL\SYRUP\ACETAMINOPHEN: HYDROCODONE
product(s) by strength(s)
acetaminophen 20 mg/ml / hydrocodone bitartrate 0.667 mg/ml oral solution
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000959090 | Lortab | ANDA | Ecr Pharmaceuticals | 2013-09-25 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SYRUP | ANDA040881 | 55386fe7-990a-4596-a109-a6553a57bc7c |
| 2 | 174780450 | Lortab | ANDA | Akorn | 2015-03-17 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SYRUP | ANDA040881 | 21def91d-b6e3-4dde-983c-6925aedf0df0 |
| 3 | 466720645 | ANDA | Mikart, Inc. | 2010-02-25 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SYRUP | ANDA040881 | 7da90197-5801-4855-956e-a9373b3dec8c |
acetaminophen 21.7 mg/ml / hydrocodone bitartrate 0.5 mg/ml oral solution
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001210772 | ANDA | Pharmaceutical Associates, Inc. | 2013-07-29 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA040838 | c29b97e9-8097-4d87-a420-ccf5aec8274a | |
| 2 | 001214772 | ANDA | Pharmaceutical Associates, Inc. | 2013-07-29 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA040838 | c29b97e9-8097-4d87-a420-ccf5aec8274a | |
| 3 | 007130703 | Hycet | ANDA | G&W Laboratories, Inc. | 2011-02-01 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA040482 | 47df0152-b0a7-d03a-01e5-b9e22c3533c8 |
| 4 | 007130704 | ANDA | G&W Laboratories, Inc. | 2011-02-01 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA040482 | fab011c0-6924-653a-832f-c5a9261790e2 | |
| 5 | 466720642 | ANDA | Mikart, Inc. | 2003-09-25 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SYRUP | ANDA040482 | 9cdd9d7e-f0b9-4d81-8f20-a16e687b479e | |
| 6 | 643760640 | ANDA | Boca Pharmacal, Llc | 2011-07-27 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA040894 | 7ce39f88-496d-490a-bab4-07d0b628ce65 | |
| 7 | 649500340 | ANDA | Lehigh Valley Technologies, Inc. | 2014-04-01 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA200343 | d54ea700-4218-4645-a9de-353d384c171e | |
| 8 | 666890023 | ANDA | Vistapharm Inc. | 2012-02-20 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA200343 | 41ebe34d-567d-4fea-9fcb-c93e990a7861 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 178560640 | ANDA | Atlantic Biologicals Corps | 2011-07-27 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | 643760640 | ANDA040894 | 21539e8e-a9b9-49ab-9134-c2cdc0a54321 |
| 2 | 545696500 | ANDA | A-S Medication Solutions Llc | 2013-07-29 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | 001210772 | ANDA040838 | de3b340f-7b58-4026-84f0-a24214bf8c49 |
| 3 | 548686437 | ANDA | Physicians Total Care, Inc. | 2014-09-12 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | 643760640 | ANDA040894 | e1580b70-08ad-4167-95ed-aa556ea8553e |
| 4 | 551544058 | ANDA | Cardinal Health | 2012-02-20 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | 666890023 | ANDA200343 | 0d41e820-f8d9-4ef3-b47f-08e2bc78191a |
| 5 | 680940714 | ANDA | Precision Dose Inc. | 2014-02-27 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | 643760640 | ANDA040894 | 1f91f8e2-c10e-43f9-9ac4-0781f197d184 |
acetaminophen 21.7 mg/ml / hydrocodone bitartrate 0.67 mg/ml oral solution
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001214771 | ANDA | Pharmaceutical Associates, Inc. | 2008-08-18 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA040834 | 793d4b68-33f8-44e8-a437-dfb7b3371998 | |
| 2 | 004860771 | Zamicet | ANDA | Beach Products, Inc. | 2015-03-18 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA040834 | 43c30b52-7bfb-4d0f-abcf-465c919a10bf |
| 3 | 004864771 | Zamicet | ANDA | Beach Products, Inc. | 2015-03-18 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA040834 | 43c30b52-7bfb-4d0f-abcf-465c919a10bf |
invalid application product(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001214655 | ANDA | Pharmaceutical Associates, Inc. | 2011-01-01 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | ANDA040182 | 3f3038e8-934a-4c5c-bd0a-f376ab97a934 | ||
| 2 | 178561295 | ANDA | Atlantic Biologicals Corps | 2003-10-30 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | 006031295 | ANDA040520 | 484a2b25-77aa-48d6-ac7f-2dcca0771505 | |
| 3 | 216950816 | ANDA | Rebel Distributors Corp | 1998-03-13 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | 001210655 | ANDA040182 | 923abdb6-1ec5-415a-9269-67e16e8e1fff | |
| 4 | 532170020 | ANDA | Aidarex Pharmaceuticals Llc | 2011-01-01 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | 001210655 | ANDA040182 | dad13e49-e79b-4cd0-bfbf-04d5704c3be0 | |
| 5 | 548682908 | Lortab | ANDA | Physicians Total Care, Inc. | 1994-08-16 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SYRUP | 504740909 | ANDA040520 | cba848e7-65fd-4b1a-ab56-50d865dcc251 |
| 6 | 548684747 | ANDA | Physicians Total Care, Inc. | 2003-03-27 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | 001210655 | ANDA040182 | f91a4c88-c083-45ab-8940-beaa9d9dcc24 |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 126340615 | ANDA | Apotheca, Inc | 2013-06-18 | ACETAMINOPHEN, HYDROCODONE BITARTRATE | ORAL | SOLUTION | 001210655 | ANDA040182 | 02610afb-bfad-47df-9913-cb2b12768f83 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA040182 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | True | PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS | 1998-03-13 | ANDA040182_001 |
| 2 | ANDA040366 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | True | NESHER PHARMACEUTICALS USA LLC | 2002-01-23 | ANDA040366_001 |
| 3 | ANDA040418 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | True | MALLINCKRODT INC | 2001-06-27 | ANDA040418_001 |
| 4 | ANDA040482 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | MIKART INC | 2003-09-25 | ANDA040482_001 | |
| 5 | ANDA040508 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | True | MALLINCKRODT INC | 2003-08-29 | ANDA040508_001 |
| 6 | ANDA040520 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | True | VINTAGE PHARMACEUTICALS INC | 2003-10-30 | ANDA040520_001 |
| 7 | ANDA040834 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | PHARMACEUTICAL ASSOC INC | 2008-04-18 | ANDA040834_001 | |
| 8 | ANDA040838 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | PHARMACEUTICAL ASSOCIATES INC | 2013-05-10 | ANDA040838_001 | |
| 9 | ANDA040881 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | MIKART INC | 2010-02-25 | ANDA040881_001 | |
| 10 | ANDA040894 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | VINTAGE PHARMACEUTICALS | 2011-07-19 | ANDA040894_001 | |
| 11 | ANDA081051 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | True | MIKART INC | 1992-08-28 | ANDA081051_001 |
| 12 | ANDA081226 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | True | MIKART INC | 1992-10-27 | ANDA081226_001 |
| 13 | ANDA089557 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | True | MIKART INC | 1992-04-29 | ANDA089557_001 |
| 14 | ANDA200343 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | VISTAPHARM INC | 2012-01-25 | ANDA200343_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040182_001 | discontinued | HYDROCODONE BITARTRATE (7.5MG/15ML), ACETAMINOPHEN (500MG/15ML) | ORAL | SOLUTION | False | 1998-03-13 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | |
| 2 | ANDA040366_001 | discontinued | ACETAMINOPHEN (500MG/15ML), HYDROCODONE BITARTRATE (7.5MG/15ML) | ORAL | SOLUTION | False | 2002-01-23 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | |
| 3 | ANDA040418_001 | discontinued | HYDROCODONE BITARTRATE (7.5MG/15ML), ACETAMINOPHEN (500MG/15ML) | ORAL | SOLUTION | False | 2001-06-27 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | |
| 4 | ANDA040482_001 | RX | ACETAMINOPHEN (325MG/15ML), HYDROCODONE BITARTRATE (7.5MG/15ML) | ORAL | SOLUTION | True | AA | 2003-09-25 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| 5 | ANDA040508_001 | discontinued | ACETAMINOPHEN (500MG/15ML), HYDROCODONE BITARTRATE (10MG/15ML) | ORAL | SOLUTION | False | 2003-08-29 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | |
| 6 | ANDA040520_001 | discontinued | HYDROCODONE BITARTRATE (7.5MG/15ML), ACETAMINOPHEN (500MG/15ML) | ORAL | SOLUTION | False | 2003-10-30 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | |
| 7 | ANDA040834_001 | RX | ACETAMINOPHEN (325MG/15ML), HYDROCODONE BITARTRATE (10MG/15ML) | ORAL | SOLUTION | True | 2008-04-18 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | |
| 8 | ANDA040838_001 | RX | ACETAMINOPHEN (325MG/15ML), HYDROCODONE BITARTRATE (7.5MG/15ML) | ORAL | SOLUTION | False | AA | 2013-05-10 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| 9 | ANDA040881_001 | RX | HYDROCODONE BITARTRATE (10MG/15ML), ACETAMINOPHEN (300MG/15ML) | ORAL | SOLUTION | True | 2010-02-25 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | |
| 10 | ANDA040894_001 | RX | ACETAMINOPHEN (325MG/15ML), HYDROCODONE BITARTRATE (7.5MG/15ML) | ORAL | SOLUTION | False | AA | 2011-07-19 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| 11 | ANDA081051_001 | discontinued | HYDROCODONE BITARTRATE (7.5MG/15ML), ACETAMINOPHEN (500MG/15ML) | ORAL | SOLUTION | False | 1992-08-28 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | |
| 12 | ANDA081226_001 | discontinued | HYDROCODONE BITARTRATE (5MG/15ML), ACETAMINOPHEN (500MG/15ML) | ORAL | SOLUTION | False | 1992-10-27 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | |
| 13 | ANDA089557_001 | discontinued | HYDROCODONE BITARTRATE (5MG/15ML), ACETAMINOPHEN (500MG/15ML) | ORAL | SOLUTION | False | 1992-04-29 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | |
| 14 | ANDA200343_001 | RX | ACETAMINOPHEN (325MG/15ML), HYDROCODONE BITARTRATE (7.5MG/15ML) | ORAL | SOLUTION | False | AA | 2012-01-25 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 02610afb-bfad-47df-9913-cb2b12768f83 (view SPL) | HYDROCODONE BITARTRATE AND ACETAMINOPHEN USP, ORAL SOLUTION CIII | prescription | Human Prescription | Apotheca, Inc | repack | 2013-09-26 | 1 | 126340615 |
| 2 | 0d41e820-f8d9-4ef3-b47f-08e2bc78191a (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored) CIII | prescription | Human Prescription | Cardinal Health | REPACK | 2014-01-29 | 1 | 551544058 |
| 3 | 1f91f8e2-c10e-43f9-9ac4-0781f197d184 (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution | prescription | Human Prescription | Precision Dose Inc. | 2014-12-24 | 2 | 680940714 | |
| 4 | 21539e8e-a9b9-49ab-9134-c2cdc0a54321 (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL) | prescription | Human Prescription | Atlantic Biologicals Corps | relabel, repack | 2015-07-13 | 4 | 178560640 |
| 5 | 21def91d-b6e3-4dde-983c-6925aedf0df0 (view SPL) | prescription | Human Prescription | Akorn | 2015-03-17 | 1 | 174780450 | ||
| 6 | 3f3038e8-934a-4c5c-bd0a-f376ab97a934 (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution 2.5 mg/167 mg per 5 mL | prescription | Human Prescription | Pharmaceutical Associates, Inc. | MANUFACTURE | 2013-12-19 | 7 | 001214655 |
| 7 | 41ebe34d-567d-4fea-9fcb-c93e990a7861 (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored) CII | prescription | Human Prescription | Vistapharm Inc. | ANALYSIS, MANUFACTURE | 2014-09-25 | 4 | 666890023 |
| 8 | 43c30b52-7bfb-4d0f-abcf-465c919a10bf (view SPL) | Zamicet CII (hydrocodone bitartrate and acetaminophen oral solution) 10 mg/325 mg per 15 mL | prescription | Human Prescription | Beach Products, Inc. | MANUFACTURE | 2015-03-20 | 1 | 004860771, 004864771 |
| 9 | 47df0152-b0a7-d03a-01e5-b9e22c3533c8 (view SPL) | Hycet CII hydrocodone bitartrate and acetaminophen oral solution7.5 mg/325 mg per 15 mL Rx only | prescription | Human Prescription | G&W Laboratories, Inc. | MANUFACTURE | 2014-09-15 | 4 | 007130703 |
| 10 | 484a2b25-77aa-48d6-ac7f-2dcca0771505 (view SPL) | HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 mg/500 mg per 15 mL | prescription | Human Prescription | Atlantic Biologicals Corps | RELABEL, REPACK | 2012-07-31 | 3 | 178561295 |
| 11 | 55386fe7-990a-4596-a109-a6553a57bc7c (view SPL) | prescription | Human Prescription | Ecr Pharmaceuticals | 2014-04-07 | 3 | 000959090 | ||
| 12 | 793d4b68-33f8-44e8-a437-dfb7b3371998 (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution 10 mg/325 mg per 15 mL CII | prescription | Human Prescription | Pharmaceutical Associates, Inc. | MANUFACTURE | 2014-10-22 | 6 | 001214771 |
| 13 | 7ce39f88-496d-490a-bab4-07d0b628ce65 (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL) | prescription | Human Prescription | Boca Pharmacal, Llc | 2015-06-17 | 5 | 643760640 | |
| 14 | 7da90197-5801-4855-956e-a9373b3dec8c (view SPL) | prescription | Human Prescription | Mikart, Inc. | 2014-09-29 | 2 | 466720645 | ||
| 15 | 923abdb6-1ec5-415a-9269-67e16e8e1fff (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/500 mg per 15 mL | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2010-09-30 | 1 | 216950816 |
| 16 | 9cdd9d7e-f0b9-4d81-8f20-a16e687b479e (view SPL) | prescription | Human Prescription | Mikart, Inc. | 2014-09-29 | 4 | 466720642 | ||
| 17 | c29b97e9-8097-4d87-a420-ccf5aec8274a (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL | prescription | Human Prescription | Pharmaceutical Associates, Inc. | MANUFACTURE | 2014-10-02 | 4 | 001210772, 001214772 |
| 18 | cba848e7-65fd-4b1a-ab56-50d865dcc251 (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2011-03-25 | 1 | 548682908 | |
| 19 | d54ea700-4218-4645-a9de-353d384c171e (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution | prescription | Human Prescription | Lehigh Valley Technologies, Inc. | 2014-11-11 | 2 | 649500340 | |
| 20 | dad13e49-e79b-4cd0-bfbf-04d5704c3be0 (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/500 mg per 15 mL | prescription | Human Prescription | Aidarex Pharmaceuticals Llc | 2013-10-01 | 1 | 532170020 | |
| 21 | de3b340f-7b58-4026-84f0-a24214bf8c49 (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL | prescription | Human Prescription | A-S Medication Solutions Llc | relabel | 2014-06-12 | 1 | 545696500 |
| 22 | e1580b70-08ad-4167-95ed-aa556ea8553e (view SPL) | Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2014-10-23 | 2 | 548686437 |
| 23 | f91a4c88-c083-45ab-8940-beaa9d9dcc24 (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2010-10-28 | 1 | 548684747 | |
| 24 | fab011c0-6924-653a-832f-c5a9261790e2 (view SPL) | Hydrocodone Bitartrate CII and AcetaminophenOral Solution7.5 mg/325 mg per 15 mL Rx only | prescription | Human Prescription | G&W Laboratories, Inc. | MANUFACTURE | 2014-09-15 | 2 | 007130704 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII