Acetazolamide
- Product NDC
- 39822-0190
- 11-digit product format
- 398220190
- Labeler code
- 39822
- Product ID
- 39822-0190_36974f91-0025-447d-e063-6294a90a0dc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetazolamide
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- XGen Pharmaceuticals DJB, Inc.
- Application
- ANDA040784
- Marketing category
- ANDA
- Marketing start
- 2008-12-10
- 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 |
|---|
| 39822-0190-1 | Acetazolamide | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 | | 33 |
| 39822-0190-1 | Acetazolamide | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 33 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAZOLAMIDE SODIUM | ACTIVE INGREDIENT | 429ZT169UH | ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 22 | |
| ACETAZOLAMIDE | ACTIVE MOIETY | O3FX965V0I | ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 22 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 22 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 22 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 39822-0190 | ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] | 32 | Current NDC, Legacy NDC, 2 package rows | 20241004_a9199d3c-ce52-4db5-aa36-408f4e15e344.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 |
|---|
| 39822-0190-1 | 39822019001 | 1 VIAL, GLASS in 1 CARTON (39822-0190-1) / 5 mL in 1 VIAL, GLASS | 2009-03-01 | 0000-00-00 | No | No | Current |