Acetazolamide
- Product NDC
- 10135-830
- 11-digit product format
- 101350830
- Labeler code
- 10135
- Product ID
- 10135-830_4a03f386-e570-d4cb-e063-6394a90a8228
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetazolamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA217197
- Marketing category
- ANDA
- Marketing start
- 2026-02-01
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-830-01 | Acetazolamide | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-830-01 | 10135083001 | 100 TABLET in 1 BOTTLE (10135-830-01) | 100 tablet | 2026-02-01 | No | No | Current |