Acetazolamide
- Product NDC
- 67457-853
- 11-digit product format
- 674570853
- Labeler code
- 67457
- Product ID
- 67457-853_300661cb-a5d8-4edc-a191-72284744e1eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetazolamide sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA200880
- Marketing category
- ANDA
- Marketing start
- 2018-09-13
- Substance
- ACETAZOLAMIDE SODIUM
- Active strength
- 500 mg/5mL
- 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 SODIUM | 500 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 429ZT169UH |
| Rxcui | 307702 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-853-50 | Acetazolamide | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 7 |
| 67457-853-50 | Acetazolamide | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-853 | ACETAZOLAMIDE (ACETAZOLAMIDE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250311_521838b0-a10d-495f-a014-f9ff25a6b6f3.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 |
|---|
| 67457-853-50 | 67457085350 | 1 VIAL in 1 CARTON (67457-853-50) / 5 mL in 1 VIAL | 1 vial | 2018-09-13 | 0000-00-00 | No | No | Current |