Adapalene
- Product NDC
- 42546-720
- 11-digit product format
- 425460720
- Labeler code
- 42546
- Product ID
- 42546-720_8ba7e13b-3c62-4726-adea-8da242edbded
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Adapalene
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- PruGen, Inc.
- Application
- ANDA091314
- Marketing category
- ANDA
- Marketing start
- 2016-03-04
- Marketing end
- 0000-00-00
- Substance
- ADAPALENE
- Active strength
- 45 g/g
- Pharmacologic classes
- Retinoid [EPC],Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42546-720-45 | Adapalene | 45 g in 1 TUBE | GEL | 45 | | 4 |
| 42546-720-45 | Adapalene | 1 in 1 CARTON | GEL | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42546-720 | ADAPALENE GEL [PRUGEN, INC.] | 4 | Legacy NDC, 2 package rows | 20180125_b85b6d8c-afbc-4ce1-9f77-e2579bf72c12.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42546-720-45 | 42546072045 | 1 TUBE in 1 CARTON (42546-720-45) > 45 g in 1 TUBE | 1 tube | 2016-03-04 | 0000-00-00 | No | No | Current |