Acetazolamide
- Product NDC
- 46708-349
- 11-digit product format
- 467080349
- Labeler code
- 46708
- Product ID
- 46708-349_d9c1cc75-4e3d-4eaf-87c5-d5942a843818
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetazolamide
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA210423
- Marketing category
- ANDA
- Marketing start
- 2019-02-20
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetazolamide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAZOLAMIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O3FX965V0I |
| Rxcui | 562524 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-349-31 | Acetazolamide | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 1 |
| 46708-349-91 | Acetazolamide | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-349 | ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, Legacy NDC, 2 package rows | 20190301_d9c1cc75-4e3d-4eaf-87c5-d5942a843818.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-349-31 | 46708034931 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-31) | 2019-02-20 | 0000-00-00 | No | No | Current |
| 46708-349-91 | 46708034991 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-91) | 2019-02-20 | 0000-00-00 | No | No | Current |