ADAPALENE
- Product NDC
- 0536-1412
- 11-digit product format
- 005361412
- Labeler code
- 0536
- Product ID
- 0536-1412_38f5232a-92be-ed71-e063-6294a90a8417
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ADAPALENE
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- RUGBY LABORATORIES, INC.
- Application
- ANDA215940
- Marketing category
- ANDA
- Marketing start
- 2024-02-20
- 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
- ADAPALENE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADAPALENE | 1 mg/g |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1412 | ADAPALENE GEL [RUGBY LABORATORIES, INC.] | 2 | Current NDC, 4 package rows | 20240406_330bc2b3-e064-4189-9c47-9c5a50aa4dde.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 |
|---|
| 0536-1412-20 | 00536141220 | 1 TUBE in 1 CARTON (0536-1412-20) / 15 g in 1 TUBE | 1 tube | 2024-02-20 | No | No | Historical |
| 0536-1412-26 | 00536141226 | 1 TUBE in 1 CARTON (0536-1412-26) / 45 g in 1 TUBE | 1 tube | 2024-02-20 | No | No | Historical |