AZELEX
- Product NDC
- 16110-869
- 11-digit product format
- 161100869
- Labeler code
- 16110
- Product ID
- 16110-869_ae821f0c-ec53-4612-a505-e1aa9d73a158
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelaic acid
- Dosage form
- CREAM
- Route
- CUTANEOUS
- Labeler
- Almirall, LLC
- Application
- NDA020428
- Marketing category
- NDA
- Marketing start
- 2018-09-24
- Substance
- AZELAIC ACID
- Active strength
- .2 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
- AZELEX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZELAIC ACID | .2 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F2VW3D43YT |
| Rxcui | 1041520, 1043753 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16110-869 | AZELEX (AZELAIC ACID) CREAM [ALMIRALL, LLC] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240308_ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75.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 |
|---|
| 16110-869-30 | 16110086930 | 1 TUBE in 1 CARTON (16110-869-30) / 30 g in 1 TUBE | 1 tube | 2019-07-12 | 0000-00-00 | No | No | Current |
| 16110-869-50 | 16110086950 | 1 TUBE in 1 CARTON (16110-869-50) / 50 g in 1 TUBE | 1 tube | 2019-07-12 | 0000-00-00 | No | No | Current |