Acetazolamide
- Product NDC
- 64380-833
- 11-digit product format
- 643800833
- Labeler code
- 64380
- Product ID
- 64380-833_69be4b8b-13c5-48f6-8c8b-58b7879152c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetazolamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA209734
- Marketing category
- ANDA
- Marketing start
- 2017-11-20
- Substance
- ACETAZOLAMIDE
- Active strength
- 125 mg/1
- Pharmacologic classes
- Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetazolamide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAZOLAMIDE | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O3FX965V0I |
| Rxcui | 197303, 197304 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 64380-833-06 | 2024-02-27 | C162847 | 48780-1 | 1030e365-65f7-111a-e063-dadaa90a10e2 | AcetaZOLAMIDE Tablets, USP |
| 64380-833-06 | 2024-02-27 | C162847 | 48780-1 | 1030e365-65f7-111a-e063-dadaa90a10e2 | AcetaZOLAMIDE Tablets, USP |
| 64380-833-46 | 2024-02-27 | C162847 | 48780-1 | 1030e365-65f7-111a-e063-dadaa90a10e2 | AcetaZOLAMIDE Tablets, USP |
| 64380-833-46 | 2024-02-27 | C162847 | 48780-1 | 1030e365-65f7-111a-e063-dadaa90a10e2 | AcetaZOLAMIDE Tablets, USP |
| 64380-833-06 | 2024-01-30 | C162847 | 48780-1 | 1030e365-65f7-111a-e063-dadaa90a10e2 | AcetaZOLAMIDE Tablets, USP |
| 64380-833-06 | 2024-01-30 | C162847 | 48780-1 | 1030e365-65f7-111a-e063-dadaa90a10e2 | AcetaZOLAMIDE Tablets, USP |
| 64380-833-46 | 2024-01-30 | C162847 | 48780-1 | 1030e365-65f7-111a-e063-dadaa90a10e2 | AcetaZOLAMIDE Tablets, USP |
| 64380-833-46 | 2024-01-30 | C162847 | 48780-1 | 1030e365-65f7-111a-e063-dadaa90a10e2 | AcetaZOLAMIDE Tablets, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-833-06 | Acetazolamide | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
| 64380-833-46 | Acetazolamide | 1000 in 1 BAG | TABLET | 1000 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-833 | ACETAZOLAMIDE TABLET [STRIDES PHARMA SCIENCE LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250129_4813b9dd-5f58-44bb-ad64-cdb331828080.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64380-833-06 | 64380083306 | 100 TABLET in 1 BOTTLE (64380-833-06) | 100 tablet | 2017-11-20 | 0000-00-00 | No | No | Current |
| 64380-833-46 | 64380083346 | 1000 TABLET in 1 BAG (64380-833-46) | 1000 tablet | 2017-11-20 | 0000-00-00 | No | No | Current |