Codeine / Promethazine Oral Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Actavis Pharma, Inc. (2012-01-01)
- Oldest Current Product
- 1984-10-31
- License(s)
- ANDA
- RxNORM
- ORAL SOLUTION\CODEINE:PROMETHAZINE
- FDAOB
- ORAL\SYRUP\CODEINE PHOSPHATE: PHENYLEPHRINE HYDROCHLORIDE: PROMETHAZINE HYDROCHLORIDE
ORAL\SYRUP\CODEINE PHOSPHATE: PROMETHAZINE HYDROCHLORIDE - SPL Active
- ORAL\LIQUID\CODEINE PHOSPHATE: PROMETHAZINE HYDROCHLORIDE
ORAL\SYRUP\CODEINE PHOSPHATE: PROMETHAZINE HYDROCHLORIDE - SPL Moiety
- ORAL\LIQUID\CODEINE: PROMETHAZINE
ORAL\SYRUP\CODEINE ANHYDROUS: PROMETHAZINE
ORAL\SYRUP\CODEINE: PROMETHAZINE
product(s) by strength(s)
codeine phosphate 2 mg/ml / promethazine hydrochloride 1.25 mg/ml oral solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004721627 | ANDA | Actavis Pharma, Inc. | 2003-01-03 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | ANDA088763 | a0bcb8ab-089d-449f-9bd6-7857d64e1692 |
| 2 | 006031585 | ANDA | Qualitest Pharmaceuticals | 2006-01-31 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | ANDA040650 | c6617697-a292-40ba-93c4-65b982715b33 |
| 3 | 278080065 | ANDA | Tris Pharma Inc | 2013-05-15 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | ANDA200386 | 785c605e-1907-4fac-8b69-d504a2076f8e |
| 4 | 503830804 | ANDA | Hi-Tech Pharmacal Co., Inc. | 1997-08-26 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | ANDA040151 | 168951c0-773d-4f3d-9745-cc6de2063b61 |
| 5 | 576640185 | ANDA | Caraco Pharmaceutical Laboratories, Ltd. | 2010-03-17 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | ANDA090180 | 1ada506d-bc8e-4455-9cdc-03433fd77bb5 |
| 6 | 604320606 | ANDA | Morton Grove Pharmaceuticals, Inc. | 1984-12-17 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | ANDA088875 | eb9ac8c2-ee04-4eed-9b0e-a25d46a7a044 |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001210547 | ANDA | Pharmaceutical Associates, Inc. | 1988-12-22 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | ANDA089647 | a5215931-3385-4d8e-b121-47aa1c20420c |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 126340907 | ANDA | Apotheca, Inc | 2012-02-16 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 576640185 | ANDA090180 | 68639fd1-3fd5-4459-8018-51f136e3ed37 |
| 2 | 126340908 | ANDA | Apotheca, Inc | 2010-01-01 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | LIQUID | 604320606 | ANDA088875 | 47d4eb4f-6dd4-44b9-aea1-19c4bfc1d425 |
| 3 | 126340909 | ANDA | Apotheca, Inc | 2009-06-01 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | LIQUID | 503830804 | ANDA040151 | 47d4eb4f-6dd4-44b9-aea1-19c4bfc1d425 |
| 4 | 178560804 | ANDA | Atlantic Biologicals Corps | 1997-08-26 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 503830804 | ANDA040151 | 5eafbdbe-58f1-4f2c-a12f-7a5d924e5fff |
| 5 | 178561585 | ANDA | Atlantic Biologicals Corps | 2006-01-31 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031585 | ANDA040650 | 4e0d550e-6281-48ce-819f-ca37fcca53e0 |
| 6 | 216950336 | ANDA | Rebel Distributors Corp | 2006-01-31 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031585 | ANDA040650 | 9408d9fa-ab74-4513-86bc-1f3d6d0dcf9a |
| 7 | 332610391 | ANDA | Aidarex Pharmaceuticals Llc | 2006-01-31 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031585 | ANDA040650 | 3150fc52-6a33-42f6-b08a-266146661a5f |
| 8 | 422540140 | ANDA | Rebel Distributors Corp | 1984-10-31 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 004721627 | ANDA088763 | a4fd8978-2036-43cb-ab16-b0dd98d6cd5b |
| 9 | 499990152 | ANDA | Lake Erie Medical Dba Quality Care Products Llc | 2012-03-21 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031585 | ANDA040650 | 9e62a7f5-c774-444b-b0cb-da800d2f3f7c |
| 10 | 500901482 | ANDA | A-S Medication Solutions Llc | 2010-03-17 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 576640185 | ANDA090180 | d2de01f9-ff2b-40b7-82a6-72c47e8e777c |
| 11 | 521250587 | ANDA | Remedyrepack Inc. | 2013-06-04 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 503830804 | ANDA040151 | f1ac200f-208b-4d6a-a89e-565d8b0d7c0e |
| 12 | 521250596 | ANDA | Remedyrepack Inc. | 2013-07-08 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 004721627 | ANDA088763 | 9a375d70-997f-4310-9829-db3be50da29e |
| 13 | 545691056 | ANDA | A-S Medication Solutions Llc | 2006-01-31 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031585 | ANDA040650 | 98fff598-835c-4efb-b10a-e975dd12f1de |
| 14 | 548681029 | ANDA | Physicians Total Care, Inc. | 2001-02-13 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031585 | ANDA040650 | 0505fe62-ac59-475e-8c94-1933398be580 |
| 15 | 631870271 | ANDA | Proficient Rx Lp | 2006-01-31 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031585 | ANDA040650 | 53e98254-eef0-4422-9891-013bd6ecb38a |
| 16 | 636291607 | ANDA | Bryant Ranch Prepack | 2003-01-03 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 004721627 | ANDA088763 | 4e2dc369-6fd8-4f7e-951d-ec62d93f84f9 |
| 17 | 687889385 | ANDA | Preferred Pharmaceuticals, Inc. | 2014-07-22 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 576640185 | ANDA090180 | 09442938-34d5-495f-8833-73cf1e7131c9 |
| 18 | 687889895 | ANDA | Preferred Pharmaceuticals, Inc. | 2012-02-14 | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031585 | ANDA040650 | 164046da-3953-437b-bc8e-a8cb0465f616 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA040151 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | HI TECH PHARMACAL CO INC | 1997-08-26 | ANDA040151_001 | ||
| 2 | ANDA040650 | PROMETHAZINE WITH CODEINE | VINTAGE PHARMACEUTICALS LLC | 2006-01-31 | ANDA040650_001 | ||
| 3 | ANDA088739 | PHERAZINE W/ CODEINE | True | HALSEY DRUG CO INC | 1988-12-23 | ANDA088739_001 | |
| 4 | ANDA088763 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | ACTAVIS MID ATLANTIC LLC | 1984-10-31 | ANDA088763_001 | ||
| 5 | ANDA088814 | PROMETHAZINE W/ CODEINE | True | HR CENCI LABORATORIES INC | 1985-11-22 | ANDA088814_001 | |
| 6 | ANDA088875 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | WOCKHARDT EU OPERATIONS (SWISS) AG | 1984-12-17 | ANDA088875_001 | ||
| 7 | ANDA089647 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | True | PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS | 1988-12-22 | ANDA089647_001 | |
| 8 | ANDA090180 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | SUN PHARMACEUTICAL INDUSTRIES INC | 2010-03-17 | ANDA090180_001 | ||
| 9 | ANDA200386 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | TRIS PHARMA INC | 2012-06-29 | ANDA200386_001 | ||
| 10 | ANDA200894 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | AMNEAL PHARMACEUTICALS | 2013-04-24 | ANDA200894_001 | ||
| 11 | NDA008306 | PHENERGAN VC W/ CODEINE | True | ANI PHARMACEUTICALS INC | 1984-04-02 | NDA008306_004, NDA008306_005 | Codeine / Phenylephrine / Promethazine Oral Solution |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040151_001 | RX | PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML) | ORAL | SYRUP | False | AA | 1997-08-26 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
| 2 | ANDA040650_001 | RX | PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML) | ORAL | SYRUP | False | AA | 2006-01-31 | PROMETHAZINE WITH CODEINE |
| 3 | ANDA088739_001 | discontinued | CODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML) | ORAL | SYRUP | False | 1988-12-23 | PHERAZINE W/ CODEINE | |
| 4 | ANDA088763_001 | RX | CODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML) | ORAL | SYRUP | True | AA | 1984-10-31 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
| 5 | ANDA088814_001 | discontinued | CODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML) | ORAL | SYRUP | False | 1985-11-22 | PROMETHAZINE W/ CODEINE | |
| 6 | ANDA088875_001 | RX | PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML) | ORAL | SYRUP | False | AA | 1984-12-17 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
| 7 | ANDA089647_001 | discontinued | CODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML) | ORAL | SYRUP | False | 1988-12-22 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | |
| 8 | ANDA090180_001 | RX | CODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML) | ORAL | SYRUP | False | AA | 2010-03-17 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
| 9 | ANDA200386_001 | RX | CODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML) | ORAL | SYRUP | False | AA | 2012-06-29 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
| 10 | ANDA200894_001 | RX | PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML) | ORAL | SYRUP | False | AA | 2013-04-24 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
| 11 | NDA008306_004 | discontinued | CODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML) | ORAL | SYRUP | False | 1984-04-02 | PHENERGAN VC W/ CODEINE | |
| 12 | NDA008306_005 | discontinued | PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML) | ORAL | SYRUP | False | 1984-04-02 | PHENERGAN VC W/ CODEINE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 0505fe62-ac59-475e-8c94-1933398be580 (view SPL) | PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2009-08-27 | 1 | 548681029 |
| 2 | 09442938-34d5-495f-8833-73cf1e7131c9 (view SPL) | Promethazine Hydrochloride and Codeine Phosphate Syrup 6.25 mg and 10mg/5 mL Rx Only CV | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | RELABEL | 2014-07-30 | 1 | 687889385 |
| 3 | 164046da-3953-437b-bc8e-a8cb0465f616 (view SPL) | PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP) | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | RELABEL | 2013-07-10 | 2 | 687889895 |
| 4 | 168951c0-773d-4f3d-9745-cc6de2063b61 (view SPL) | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP | prescription | Human Prescription | Hi-Tech Pharmacal Co., Inc. | MANUFACTURE | 2015-06-22 | 12 | 503830804 |
| 5 | 1ada506d-bc8e-4455-9cdc-03433fd77bb5 (view SPL) | Promethazine Hydrochloride and Codeine Phosphate Syrup 6.25 mg and 10mg/5 mLRx Only CV | prescription | Human Prescription | Caraco Pharmaceutical Laboratories, Ltd. | ANALYSIS, MANUFACTURE, PACK | 2015-08-27 | 7 | 576640185 |
| 6 | 3150fc52-6a33-42f6-b08a-266146661a5f (view SPL) | PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP) | prescription | Human Prescription | Aidarex Pharmaceuticals Llc | 2014-01-29 | 1 | 332610391 | |
| 7 | 47d4eb4f-6dd4-44b9-aea1-19c4bfc1d425 (view SPL) | PROMETHAZINE HCI AND CODEINE PHOSPHATE 6.25MG/10MG PER 5ML RX ONLY | prescription | Human Prescription | Apotheca, Inc | 2010-03-09 | 1 | 126340908, 126340909 | |
| 8 | 4e0d550e-6281-48ce-819f-ca37fcca53e0 (view SPL) | PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP) | prescription | Human Prescription | Atlantic Biologicals Corps | RELABEL, REPACK | 2013-03-05 | 2 | 178561585 |
| 9 | 4e2dc369-6fd8-4f7e-951d-ec62d93f84f9 (view SPL) | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP | prescription | Human Prescription | Bryant Ranch Prepack | RELABEL, REPACK | 2014-07-18 | 1000 | 636291607 |
| 10 | 53e98254-eef0-4422-9891-013bd6ecb38a (view SPL) | PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP) | prescription | Human Prescription | Proficient Rx Lp | RELABEL, REPACK | 2014-11-01 | 1 | 631870271 |
| 11 | 5eafbdbe-58f1-4f2c-a12f-7a5d924e5fff (view SPL) | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP | prescription | Human Prescription | Atlantic Biologicals Corps | RELABEL, REPACK | 2012-04-13 | 2 | 178560804 |
| 12 | 68639fd1-3fd5-4459-8018-51f136e3ed37 (view SPL) | Promethazine Hydrochloride and Codeine Phosphate Syrup 6.25 mg and 10mg/5 mLRx Only CV | prescription | Human Prescription | Apotheca, Inc | repack | 2013-10-07 | 2 | 126340907 |
| 13 | 785c605e-1907-4fac-8b69-d504a2076f8e (view SPL) | Promethazine Hydrochloride and Codeine Phosphate Syrup | prescription | Human Prescription | Tris Pharma Inc | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2013-02-21 | 4 | 278080065 |
| 14 | 9408d9fa-ab74-4513-86bc-1f3d6d0dcf9a (view SPL) | PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP) | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2010-11-11 | 2 | 216950336 |
| 15 | 98fff598-835c-4efb-b10a-e975dd12f1de (view SPL) | PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP) | prescription | Human Prescription | A-S Medication Solutions Llc | relabel | 2013-05-01 | 1 | 545691056 |
| 16 | 9a375d70-997f-4310-9829-db3be50da29e (view SPL) | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP | prescription | Human Prescription | Remedyrepack Inc. | 2013-07-08 | 2 | 521250596 | |
| 17 | 9e62a7f5-c774-444b-b0cb-da800d2f3f7c (view SPL) | PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP) | prescription | Human Prescription | Lake Erie Medical Dba Quality Care Products Llc | relabel, repack | 2012-03-21 | 3688 | 499990152 |
| 18 | a0bcb8ab-089d-449f-9bd6-7857d64e1692 (view SPL) | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP | prescription | Human Prescription | Actavis Pharma, Inc. | MANUFACTURE | 2012-01-01 | 3 | 004721627 |
| 19 | a4fd8978-2036-43cb-ab16-b0dd98d6cd5b (view SPL) | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP CV FORM NO. 1627 Rev. 1/09 VC3276 Rx Only | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2012-01-24 | 1 | 422540140 |
| 20 | a5215931-3385-4d8e-b121-47aa1c20420c (view SPL) | PROMETHAZINE HCL AND CODEINE PHOSPHATE SYRUP CV | prescription | Human Prescription | Pharmaceutical Associates, Inc. | MANUFACTURE | 2013-03-21 | 2 | 001210547 |
| 21 | c6617697-a292-40ba-93c4-65b982715b33 (view SPL) | PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP) | prescription | Human Prescription | Qualitest Pharmaceuticals | MANUFACTURE | 2015-02-05 | 6 | 006031585 |
| 22 | d2de01f9-ff2b-40b7-82a6-72c47e8e777c (view SPL) | Promethazine Hydrochloride and Codeine Phosphate Syrup 6.25 mg and 10mg/5 mLRx Only CV | prescription | Human Prescription | A-S Medication Solutions Llc | relabel | 2014-12-15 | 1 | 500901482 |
| 23 | eb9ac8c2-ee04-4eed-9b0e-a25d46a7a044 (view SPL) | PROMETHAZINE AND CODEINEPromethazine Hydrochloride and CodeinePhosphate Syrup CV | prescription | Human Prescription | Morton Grove Pharmaceuticals, Inc. | 2013-05-28 | 4 | 604320606 | |
| 24 | f1ac200f-208b-4d6a-a89e-565d8b0d7c0e (view SPL) | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP | prescription | Human Prescription | Remedyrepack Inc. | 2013-06-04 | 1 | 521250587 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII