Acetazolamide
- Product NDC
- 81005-104
- 11-digit product format
- 810050104
- Labeler code
- 81005
- Product ID
- 81005-104_45753e50-34f0-97e1-e063-6394a90abd3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetazolamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aarkish Pharmaceuticals NJ Inc.
- Application
- ANDA217197
- Marketing category
- ANDA
- Marketing start
- 2024-12-03
- 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
- 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 | 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 |
|---|
| 81005-104-01 | Acetazolamide | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 81005-104-10 | Acetazolamide | 1000 in 1 BOTTLE | TABLET | 1000 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81005-104 | ACETAZOLAMIDE TABLET [AARKISH PHARMACEUTICALS NJ INC.] | 6 | Current NDC, 2 package rows | 20241215_ddfd44dc-3136-4dda-8ed0-eb2991c2a0b6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81005-104-01 | 81005010401 | 100 TABLET in 1 BOTTLE (81005-104-01) | 100 tablet | 2024-12-03 | No | No | Historical |
| 81005-104-10 | 81005010410 | 1000 TABLET in 1 BOTTLE (81005-104-10) | 1000 tablet | 2024-12-03 | No | No | Historical |