Amcinonide
- Product NDC
- 0168-0278
- 11-digit product format
- 001680278
- Labeler code
- 0168
- Product ID
- 0168-0278_51093468-b64d-4b34-9627-8e6313c8265e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amcinonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Fougera Pharmaceuticals Inc.
- Application
- ANDA076065
- Marketing category
- ANDA
- Marketing start
- 2003-05-15
- Substance
- AMCINONIDE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amcinonide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMCINONIDE | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423W026MA9 |
| Rxcui | 197327 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0278 | AMCINONIDE CREAM [FOUGERA PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 6 package rows | 20220702_8aefa477-ac2c-41c8-a807-d24522aed8f0.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 |
|---|
| 0168-0278-15 | 00168027815 | 1 TUBE in 1 CARTON (0168-0278-15) / 15 g in 1 TUBE | 1 tube | 2003-05-15 | 0000-00-00 | No | No | Current |
| 0168-0278-30 | 00168027830 | 1 TUBE in 1 CARTON (0168-0278-30) / 30 g in 1 TUBE | 1 tube | 2003-05-15 | 0000-00-00 | No | No | Current |
| 0168-0278-60 | 00168027860 | 1 TUBE in 1 CARTON (0168-0278-60) / 60 g in 1 TUBE | 1 tube | 2003-05-15 | 0000-00-00 | No | No | Current |