Azelaic Acid Gel
- Product NDC
- 72162-2297
- 11-digit product format
- 721622297
- Labeler code
- 72162
- Product ID
- 72162-2297_92d67e5a-c010-4edf-bce7-858c8a4cc818
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelaic Acid
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azelaic Acid Gel
- Listing expiration
- 2027-12-31
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 |
|---|
| 72162-2297-2 | Azelaic Acid Gel | 1 in 1 CARTON | GEL | 1 | | 103 |
| 72162-2297-2 | Azelaic Acid Gel | 50 g in 1 TUBE | GEL | 50 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2297 | AZELAIC ACID GEL (AZELAIC ACID) GEL [BRYANT RANCH PREPACK] | 101 | Current NDC, 2 package rows | 20241122_9c151fc7-cb0b-4931-9c1b-0c29f46ac21f.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 |
|---|
| 72162-2297-2 | 72162229702 | 1 TUBE in 1 CARTON (72162-2297-2) / 50 g in 1 TUBE | 1 tube | 2023-11-30 | No | No | Current |