Acetazolamide
- Product NDC
- 68083-661
- 11-digit product format
- 680830661
- Labeler code
- 68083
- Product ID
- 68083-661_de1a5d68-b82d-4a84-9362-f7edd73f377a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetazolamide
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA219775
- Marketing category
- ANDA
- Marketing start
- 2025-06-17
- 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 |
|---|
| 68083-661-01 | Acetazolamide | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 3 |
| 68083-661-01 | Acetazolamide | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-661-01 | 68083066101 | 1 VIAL in 1 CARTON (68083-661-01) / 5 mL in 1 VIAL | 1 vial | 2025-06-17 | No | No | Historical |