Azelaic Acid Gel
- Product NDC
- 0781-7172
- 11-digit product format
- 007817172
- Labeler code
- 0781
- Product ID
- 0781-7172_d6c8343f-d169-4924-9fa2-4fbf097a32a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelaic acid
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Sandoz Inc.
- Application
- NDA021470
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-10-01
- 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 |
|---|
| 0781-7172-50 | Azelaic Acid Gel | 50 g in 1 TUBE | GEL | 50 | | 8 |
| 0781-7172-50 | Azelaic Acid Gel | 1 in 1 CARTON | GEL | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-7172 | AZELAIC ACID GEL (AZELAIC ACID) GEL [SANDOZ INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20211116_66178511-5c1a-4ecd-bc98-2ceb54e710ac.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 |
|---|
| 0781-7172-50 | 00781717250 | 1 TUBE in 1 CARTON (0781-7172-50) / 50 g in 1 TUBE | 1 tube | 2018-10-01 | 0000-00-00 | No | No | Current |