Acetazolamide Oral Tablet
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Taro Pharmaceuticals U.S.A., Inc. (2015-10-09)
- Oldest Current Product
- 1978-03-31
- License(s)
- ANDA
- RxNORM
- ORAL TABLET\ACETAZOLAMIDE
- FDAOB
- ORAL\TABLET\ACETAZOLAMIDE
- SPL Active
- ORAL\TABLET\ACETAZOLAMIDE
- SPL Moiety
- ORAL\TABLET\ACETAZOLAMIDE
product(s) by strength(s)
acetazolamide 125 mg oral tablet
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 516724022 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 1997-05-28 | ACETAZOLAMIDE | ORAL | TABLET | ANDA040195 | abeb13eb-66a5-4030-9bc2-5981acd196b9 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 545694387 | ANDA | A-S Medication Solutions Llc | 1997-05-28 | ACETAZOLAMIDE | ORAL | TABLET | 516724022 | ANDA040195 | 3e1d2008-3649-485f-ba30-4b966e360585 |
| 2 | 552890720 | ANDA | Pd-Rx Pharmaceuticals, Inc. | 1997-05-28 | ACETAZOLAMIDE | ORAL | TABLET | 516724022 | ANDA040195 | bd911de5-ea56-41ba-a328-20c8bfe7fe3b |
| 3 | 604290033 | ANDA | Golden State Medical Supply, Inc. | 1997-05-28 | ACETAZOLAMIDE | ORAL | TABLET | 516724022 | ANDA040195 | ceb5cac3-bbfb-42fa-8b29-c0ef5ed0913c |
acetazolamide 250 mg oral tablet
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 005271050 | ANDA | Lannett Company, Inc. | 1978-03-31 | ACETAZOLAMIDE | ORAL | TABLET | ANDA084840 | c1c76f21-e1fc-40ea-947a-bc9c752f80c8 |
| 2 | 101350567 | ANDA | Marlex Pharmaceuticals Inc | 2014-10-01 | ACETAZOLAMIDE | ORAL | TABLET | ANDA084840 | 8cd20635-91d0-4565-bc2c-778806178ac8 |
| 3 | 516724023 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 1997-05-28 | ACETAZOLAMIDE | ORAL | TABLET | ANDA040195 | abeb13eb-66a5-4030-9bc2-5981acd196b9 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 006151511 | ANDA | Ncs Healthcare Of Ky, Inc Dba Vangard Labs | 1997-05-28 | ACETAZOLAMIDE | ORAL | TABLET | 516724023 | ANDA040195 | 8101a7a6-d5cf-43ab-8f55-7909eba27add |
| 2 | 422910103 | ANDA | Avkare, Inc. | 2012-07-02 | ACETAZOLAMIDE | ORAL | TABLET | 005271050 | ANDA084840 | 1cb912d1-0d48-7e6f-a7b6-f766be6b86b0 |
| 3 | 521250095 | ANDA | Remedyrepack Inc. | 2013-03-11 | ACETAZOLAMIDE | ORAL | TABLET | 005271050 | ANDA084840 | b8ea24ea-450f-4459-a40f-78a9a4dfe581 |
| 4 | 521250182 | ANDA | Remedyrepack Inc. | 2013-03-27 | ACETAZOLAMIDE | ORAL | TABLET | 516724023 | ANDA040195 | 2bda071e-0f9c-4a13-be9f-513145e32723 |
| 5 | 545691697 | ANDA | A-S Medication Solutions Llc | 1997-05-28 | ACETAZOLAMIDE | ORAL | TABLET | 516724023 | ANDA040195 | ef46f395-997f-4d55-8461-b418bd3a53bb |
| 6 | 548681195 | ANDA | Physicians Total Care, Inc. | 2010-02-09 | ACETAZOLAMIDE | ORAL | TABLET | 005271050 | ANDA084840 | 59050278-167e-4641-a253-4e57653f8b6b |
| 7 | 551543025 | ANDA | Cardinal Health | 1997-05-28 | ACETAZOLAMIDE | ORAL | TABLET | 516724023 | ANDA040195 | 14271670-a13b-4f7d-a27b-a92a27199cc6, bc614baa-8649-4fea-a482-ee121fd3dcd6 |
| 8 | 552890221 | ANDA | Pd-Rx Pharmaceuticals, Inc. | 1997-05-28 | ACETAZOLAMIDE | ORAL | TABLET | 516724023 | ANDA040195 | aa0796a0-2687-4cd6-b0d9-a5bf957c0d07 |
| 9 | 604290034 | ANDA | Golden State Medical Supply, Inc. | 1997-05-28 | ACETAZOLAMIDE | ORAL | TABLET | 516724023 | ANDA040195 | ceb5cac3-bbfb-42fa-8b29-c0ef5ed0913c |
| 10 | 672960801 | ANDA | Redpharm Drug Inc. | 1978-03-31 | ACETAZOLAMIDE | ORAL | TABLET | 005271050 | ANDA084840 | 6972d9c1-36ec-4246-bf7b-13206d5952c3 |
| 11 | 680840541 | ANDA | American Health Packaging | 2011-11-01 | ACETAZOLAMIDE | ORAL | TABLET | 005271050 | ANDA084840 | 7bcb16ee-2233-462c-bf6f-4d55eecbed29 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA040195 | ACETAZOLAMIDE | TARO PHARMACEUTICAL INDUSTRIES LTD | 1997-05-28 | ANDA040195_001, ANDA040195_002 | |
| 2 | ANDA083320 | ACETAZOLAMIDE | True | ALRA LABORATORIES INC | ANDA083320_001 | |
| 3 | ANDA084498 | ACETAZOLAMIDE | True | WATSON LABORATORIES INC | ANDA084498_002 | |
| 4 | ANDA084840 | ACETAZOLAMIDE | LANNETT CO INC | ANDA084840_001 | ||
| 5 | ANDA087654 | ACETAZOLAMIDE | True | VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO | 1982-02-05 | ANDA087654_001 |
| 6 | ANDA087686 | ACETAZOLAMIDE | True | ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC | 1982-10-20 | ANDA087686_001 |
| 7 | ANDA088882 | ACETAZOLAMIDE | True | WATSON LABORATORIES INC | 1985-10-22 | ANDA088882_001 |
| 8 | ANDA089752 | ACETAZOLAMIDE | MUTUAL PHARMACEUTICAL CO INC | 1988-06-22 | ANDA089752_001 | |
| 9 | ANDA089753 | ACETAZOLAMIDE | True | MUTUAL PHARMACEUTICAL CO INC | 1988-06-22 | ANDA089753_001 |
| 10 | NDA008943 | DIAMOX | True | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC | NDA008943_001, NDA008943_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040195_001 | RX | ACETAZOLAMIDE (125MG) | ORAL | TABLET | False | AB | 1997-05-28 | ACETAZOLAMIDE |
| 2 | ANDA040195_002 | RX | ACETAZOLAMIDE (250MG) | ORAL | TABLET | True | AB | 1997-05-28 | ACETAZOLAMIDE |
| 3 | ANDA083320_001 | discontinued | ACETAZOLAMIDE (250MG) | ORAL | TABLET | False | ACETAZOLAMIDE | ||
| 4 | ANDA084498_002 | discontinued | ACETAZOLAMIDE (250MG) | ORAL | TABLET | False | ACETAZOLAMIDE | ||
| 5 | ANDA084840_001 | RX | ACETAZOLAMIDE (250MG) | ORAL | TABLET | False | AB | ACETAZOLAMIDE | |
| 6 | ANDA087654_001 | discontinued | ACETAZOLAMIDE (250MG) | ORAL | TABLET | False | 1982-02-05 | ACETAZOLAMIDE | |
| 7 | ANDA087686_001 | discontinued | ACETAZOLAMIDE (250MG) | ORAL | TABLET | False | 1982-10-20 | ACETAZOLAMIDE | |
| 8 | ANDA088882_001 | discontinued | ACETAZOLAMIDE (250MG) | ORAL | TABLET | False | 1985-10-22 | ACETAZOLAMIDE | |
| 9 | ANDA089752_001 | RX | ACETAZOLAMIDE (125MG) | ORAL | TABLET | False | AB | 1988-06-22 | ACETAZOLAMIDE |
| 10 | ANDA089753_001 | discontinued | ACETAZOLAMIDE (250MG) | ORAL | TABLET | False | 1988-06-22 | ACETAZOLAMIDE | |
| 11 | NDA008943_001 | discontinued | ACETAZOLAMIDE (125MG) | ORAL | TABLET | False | DIAMOX | ||
| 12 | NDA008943_002 | discontinued | ACETAZOLAMIDE (250MG) | ORAL | TABLET | False | DIAMOX |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 14271670-a13b-4f7d-a27b-a92a27199cc6 (view SPL) | AcetaZOLAMIDE Tablet USP | prescription | Human Prescription | Cardinal Health | REPACK | 2011-03-31 | 1 | 551543025 |
| 2 | 1cb912d1-0d48-7e6f-a7b6-f766be6b86b0 (view SPL) | AcetaZOLAMIDE TABLETS USP | prescription | Human Prescription | Avkare, Inc. | 2015-10-22 | 3 | 422910103 | |
| 3 | 2bda071e-0f9c-4a13-be9f-513145e32723 (view SPL) | Acetazolamide Tablets USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-03-27 | 1 | 521250182 | |
| 4 | 3e1d2008-3649-485f-ba30-4b966e360585 (view SPL) | Acetazolamide Tablets USP | prescription | Human Prescription | A-S Medication Solutions Llc | repack | 2013-06-29 | 1 | 545694387 |
| 5 | 59050278-167e-4641-a253-4e57653f8b6b (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel, repack | 2012-09-18 | 2 | 548681195 | |
| 6 | 6972d9c1-36ec-4246-bf7b-13206d5952c3 (view SPL) | AcetaZOLAMIDE TABLETS USP | prescription | Human Prescription | Redpharm Drug Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2011-08-05 | 1 | 672960801 |
| 7 | 7bcb16ee-2233-462c-bf6f-4d55eecbed29 (view SPL) | AcetaZOLAMIDE TABLETS USP | prescription | Human Prescription | American Health Packaging | repack | 2015-10-13 | 2 | 680840541 |
| 8 | 8101a7a6-d5cf-43ab-8f55-7909eba27add (view SPL) | AcetaZOLAMIDE Tablet USP | prescription | Human Prescription | Ncs Healthcare Of Ky, Inc Dba Vangard Labs | RELABEL, REPACK | 2011-10-26 | 1 | 006151511 |
| 9 | 8cd20635-91d0-4565-bc2c-778806178ac8 (view SPL) | AcetaZOLAMIDE TABLETS USP | prescription | Human Prescription | Marlex Pharmaceuticals Inc | 2015-03-13 | 1 | 101350567 | |
| 10 | aa0796a0-2687-4cd6-b0d9-a5bf957c0d07 (view SPL) | Acetazolamide Tablets USP | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2011-12-08 | 2 | 552890221 |
| 11 | abeb13eb-66a5-4030-9bc2-5981acd196b9 (view SPL) | AcetaZOLAMIDE Tablets USP | prescription | Human Prescription | Taro Pharmaceuticals U.S.A., Inc. | MANUFACTURE | 2015-10-09 | 4 | 516724022, 516724023 |
| 12 | b8ea24ea-450f-4459-a40f-78a9a4dfe581 (view SPL) | AcetaZOLAMIDE TABLETS USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-03-11 | 1 | 521250095 | |
| 13 | bc614baa-8649-4fea-a482-ee121fd3dcd6 (view SPL) | AcetaZOLAMIDE Tablet USP | prescription | Human Prescription | Cardinal Health | REPACK | 2011-05-04 | 1 | 551543025 |
| 14 | bd911de5-ea56-41ba-a328-20c8bfe7fe3b (view SPL) | Acetazolamide Tablets USP | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2011-12-08 | 2 | 552890720 |
| 15 | c1c76f21-e1fc-40ea-947a-bc9c752f80c8 (view SPL) | AcetaZOLAMIDE TABLETS USP | prescription | Human Prescription | Lannett Company, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2010-11-02 | 4 | 005271050 |
| 16 | ceb5cac3-bbfb-42fa-8b29-c0ef5ed0913c (view SPL) | AcetaZOLAMIDE Tablet USP | prescription | Human Prescription | Golden State Medical Supply, Inc. | RELABEL, REPACK | 2011-07-01 | 2 | 604290033, 604290034 |
| 17 | ef46f395-997f-4d55-8461-b418bd3a53bb (view SPL) | Acetazolamide Tablets USP | prescription | Human Prescription | A-S Medication Solutions Llc | repack | 2013-06-29 | 1 | 545691697 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII