azelaic acid
- Product NDC
- 0591-2131
- 11-digit product format
- 005912131
- Labeler code
- 0591
- Product ID
- 0591-2131_38d8c966-bb27-4b39-b436-4e7ffbd2d134
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelaic acid
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA208011
- Marketing category
- ANDA
- Marketing start
- 2018-11-19
- Substance
- AZELAIC ACID
- Active strength
- .15 g/g
- Pharmacologic classes
- Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- azelaic acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZELAIC ACID | .15 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F2VW3D43YT |
| Rxcui | 1041518 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-2131-55 | azelaic acid | 1 in 1 CARTON | GEL | 1 | | 11 |
| 0591-2131-55 | azelaic acid | 50 g in 1 TUBE | GEL | 50 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2131 | AZELAIC ACID GEL [ACTAVIS PHARMA, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20231230_66298d50-d4e2-4852-bbab-581389c488cb.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 |
|---|
| 0591-2131-55 | 00591213155 | 1 TUBE in 1 CARTON (0591-2131-55) / 50 g in 1 TUBE | 1 tube | 2018-11-19 | 0000-00-00 | No | No | Current |