ADAPALENE AND BENZOYL PEROXIDE
- Product NDC
- 63629-9322
- 11-digit product format
- 636299322
- Labeler code
- 63629
- Product ID
- 63629-9322_f679bcb4-f0b3-472f-8df4-a8fd4337eca6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- adapalene and benzoyl peroxide
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212464
- Marketing category
- ANDA
- Marketing start
- 2022-06-02
- Substance
- ADAPALENE; BENZOYL PEROXIDE
- Active strength
- 3; 25 mg/g; 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 AND BENZOYL PEROXIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADAPALENE | 3 mg/g |
| BENZOYL PEROXIDE | 25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF, W9WZN9A0GM |
| Rxcui | 1663745 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-9322-1 | ADAPALENE AND BENZOYL PEROXIDE | 45 g in 1 BOTTLE, PUMP | GEL | 45 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-9322 | ADAPALENE AND BENZOYL PEROXIDE GEL [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 1 package rows | 20240116_91161d2f-8990-4268-bd74-f60cf33aa2a1.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 |
|---|
| 63629-9322-1 | 63629932201 | 45 g in 1 BOTTLE, PUMP (63629-9322-1) | 45 g | 2022-07-07 | 0000-00-00 | No | No | Current |