Azelaic Acid
- Product NDC
- 51672-1389
- 11-digit product format
- 516721389
- Labeler code
- 51672
- Product ID
- 51672-1389_3cf92843-22fd-ba71-e063-6294a90a1fc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelaic Acid
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA210549
- Marketing category
- ANDA
- Marketing start
- 2019-08-23
- 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 |
|---|
| 51672-1389-3 | Azelaic Acid | 50 g in 1 TUBE | GEL | 50 | | 5 |
| 51672-1389-3 | Azelaic Acid | 1 in 1 CARTON | GEL | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-1389 | AZELAIC ACID GEL [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220129_d4e9e95d-1ebd-44df-a91e-59819715659c.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 |
|---|
| 51672-1389-3 | 51672138903 | 1 TUBE in 1 CARTON (51672-1389-3) / 50 g in 1 TUBE | 1 tube | 2019-08-23 | 0000-00-00 | No | No | Current |