Azelaic Acid Gel
- Product NDC
- 21922-038
- 11-digit product format
- 219220038
- Labeler code
- 21922
- Product ID
- 21922-038_433f2929-0ee4-4b1f-a548-eff7b66e7fb6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelaic Acid
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA208724
- Marketing category
- ANDA
- Marketing start
- 2023-11-30
- 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 Gel
- 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 |
|---|
| 21922-038-14 | Azelaic Acid Gel | 50 g in 1 TUBE | GEL | 50 | | 3 |
| 21922-038-14 | Azelaic Acid Gel | 1 in 1 CARTON | GEL | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-038 | AZELAIC ACID GEL (AZELAIC ACID) GEL [ENCUBE ETHICALS PRIVATE LIMITED] | 1 | Current NDC, 2 package rows | 20231201_ab3f174c-a3c4-4ae9-b0bc-954efaadf8de.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 |
|---|
| 21922-038-14 | 21922003814 | 1 TUBE in 1 CARTON (21922-038-14) / 50 g in 1 TUBE | 1 tube | 2023-11-30 | No | No | Current |