azelaic acid
- Product NDC
- 68462-626
- 11-digit product format
- 684620626
- Labeler code
- 68462
- Product ID
- 68462-626_28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelaic acid
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA204637
- 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 |
|---|
| 68462-626-52 | azelaic acid | 1 in 1 CARTON | GEL | 1 | | 5 |
| 68462-626-52 | azelaic acid | 50 g in 1 TUBE | GEL | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-626 | AZELAIC ACID GEL [GLENMARK PHARMACEUTICALS INC., USA] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240104_0b5ab22e-c78a-4429-9a76-a4ba2d11fcde.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 |
|---|
| 68462-626-52 | 68462062652 | 1 TUBE in 1 CARTON (68462-626-52) / 50 g in 1 TUBE | 1 tube | 2018-11-19 | 0000-00-00 | No | No | Current |