Adapalene
- Product NDC
- 68462-403
- 11-digit product format
- 684620403
- Labeler code
- 68462
- Product ID
- 68462-403_05bd24b5-2fa0-40f8-8640-b6f8265389e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Adapalene
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA091314
- Marketing category
- ANDA
- Marketing start
- 2010-07-01
- Marketing end
- 0000-00-00
- Substance
- ADAPALENE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Retinoid [EPC],Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a46239a7-5963-4008-8cbb-6b9000f497eb | Product name | 1 | 20250721 |
| d9d61457-6a5a-41fc-b418-e5479a2904b7 | Product name | 2 | 20230303 |
| 91d0a1ed-5d14-5017-c7aa-3602ee038695 | Product name | 3 | 20210111 |
| 3f45980c-c196-47e5-0e5e-48b7c57327c5 | Product name | 5 | 20200428 |
| 5c3dfd42-8936-4261-a420-cfcbbf3030aa | Product name | 2 | 20161206 |
| 08f39758-2d46-8afe-73ca-39fe69052a2b | Product name | 1 | 20140508 |
| 8ae7bcde-1dd2-b073-852b-f464987f7427 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-403-55 | GM - Gram | 68462-403 | 4ef0d5cd-9b6e-4f98-aab8-a9e4e161151a | 1 | 2012-07-24 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307731 | adapalene 0.1 % Topical Gel | PSN | 69846bde-5f7e-4b40-8a67-fbd15d80cfbd | 9 |
| 307731 | adapalene 0.001 MG/MG Topical Gel | SCD | 69846bde-5f7e-4b40-8a67-fbd15d80cfbd | 9 |
| 307731 | adapalene 0.1 % Topical Gel | SY | 69846bde-5f7e-4b40-8a67-fbd15d80cfbd | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68462-403-55 | 68462040355 | 45 g in 1 TUBE (68462-403-55) | 45 g | 2010-07-01 | 0000-00-00 | No | No | Current |