ACETAZOLAMIDE
- Product NDC
- 68382-261
- 11-digit product format
- 683820261
- Labeler code
- 68382
- Product ID
- 68382-261_a716c034-37bf-4646-a49f-5c827e7cc6a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetazolamide
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA040904
- Marketing category
- ANDA
- Marketing start
- 2008-12-15
- Marketing end
- 2020-11-30
- Substance
- ACETAZOLAMIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68382-261-01 | 2020-02-07 | C162847 | 48780-1 | 9d75b9d0-f622-f424-e053-dadaa90a57ce | ff46457a-8029-40b0-90c7-9932d7cca4fb |
| 68382-261-10 | 2020-02-07 | C162847 | 48780-1 | 9d75b9d0-f622-f424-e053-dadaa90a57ce | ff46457a-8029-40b0-90c7-9932d7cca4fb |
| 68382-261-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f622-f424-e053-dadaa90a57ce | ff46457a-8029-40b0-90c7-9932d7cca4fb |
| 68382-261-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f622-f424-e053-dadaa90a57ce | ff46457a-8029-40b0-90c7-9932d7cca4fb |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-261-01 | EA - Each | 68382-261 | 7fc26c75-98eb-4f44-a2a3-7c54cfef2ae4 | 1 | 2012-07-24 |