Effaclar
- Product NDC
- 49967-591
- 11-digit product format
- 499670591
- Labeler code
- 49967
- Product ID
- 49967-591_b42708ac-ccbb-4494-aeec-8a8acea67ca4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Adapalene
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- L�Oreal USA Products Inc
- Application
- ANDA091314
- Marketing category
- ANDA
- Marketing start
- 2019-08-23
- Substance
- ADAPALENE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Effaclar
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADAPALENE | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF |
| Rxcui | 307731 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49967-591 | EFFACLAR (ADAPALENE) GEL [L’OREAL USA PRODUCTS INC] | 2 | Current NDC, Legacy NDC, 4 package rows | 20230118_a47b204a-3815-4a2b-9a7d-2c2b65b837bb.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 |
|---|
| 49967-591-01 | 49967059101 | 1 TUBE in 1 CARTON (49967-591-01) / 45 g in 1 TUBE | 1 tube | 2019-08-23 | 0000-00-00 | No | No | Current |
| 49967-591-02 | 49967059102 | 1 TUBE in 1 CARTON (49967-591-02) / 3 g in 1 TUBE | 1 tube | 2019-10-22 | 0000-00-00 | No | No | Current |