Halcinonide
- Product NDC
- 0378-8056
- 11-digit product format
- 003788056
- Labeler code
- 0378
- Product ID
- 0378-8056_09b49bcc-a3cf-4281-a753-65866b2b8c3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Halcinonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA211027
- Marketing category
- ANDA
- Marketing start
- 2019-08-15
- Substance
- HALCINONIDE
- 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
- Halcinonide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HALCINONIDE | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SI86V6QNEG |
| Rxcui | 103467 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-8056-49 | Halcinonide | 30 g in 1 TUBE | CREAM | 30 | | 2 |
| 0378-8056-49 | Halcinonide | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 0378-8056-60 | Halcinonide | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 0378-8056-60 | Halcinonide | 60 g in 1 TUBE | CREAM | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8056 | HALCINONIDE CREAM [MYLAN PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20190907_b7d78c72-a683-4208-b7dd-5523502c036c.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 |
|---|
| 0378-8056-49 | 00378805649 | 1 TUBE in 1 CARTON (0378-8056-49) / 30 g in 1 TUBE | 1 tube | 2019-08-15 | 0000-00-00 | No | No | Current |
| 0378-8056-60 | 00378805660 | 1 TUBE in 1 CARTON (0378-8056-60) / 60 g in 1 TUBE | 1 tube | 2019-08-15 | 0000-00-00 | No | No | Current |