Adapalene
- Product NDC
- 0168-0424
- 11-digit product format
- 001680424
- Labeler code
- 0168
- Product ID
- 0168-0424_3704e230-6ad8-448d-a4bf-a86c449837b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- adapalene
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Application
- ANDA090824
- Marketing category
- ANDA
- Marketing start
- 2010-06-30
- Substance
- ADAPALENE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF |
| Rxcui | 313852 |
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 |
|---|
| 0168-0424-46 | Adapalene | 1 in 1 CARTON | CREAM | 1 | | 10 |
| 0168-0424-46 | Adapalene | 45 g in 1 TUBE | CREAM | 45 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ADAPALENE | ACTIVE INGREDIENT | 1L4806J2QF | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| ADAPALENE | ACTIVE MOIETY | 1L4806J2QF | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | INACTIVE INGREDIENT | Z135WT9208 | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| CYCLOMETHICONE | INACTIVE INGREDIENT | NMQ347994Z | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| SQUALENE | INACTIVE INGREDIENT | 7QWM220FJH | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| ADAPALENE | ACTIVE INGREDIENT | 1L4806J2QF | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| ADAPALENE | ACTIVE MOIETY | 1L4806J2QF | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| CYCLOMETHICONE | INACTIVE INGREDIENT | NMQ347994Z | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0424 | ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240821_276f7cce-5f54-40f8-8321-9192d0e52a73.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 |
|---|
| 0168-0424-46 | 00168042446 | 1 TUBE in 1 CARTON (0168-0424-46) / 45 g in 1 TUBE | 1 tube | 2010-06-30 | 0000-00-00 | No | No | Current |