Hydrocortisone Butyrate
- Product NDC
- 83148-012
- 11-digit product format
- 831480012
- Labeler code
- 83148
- Product ID
- 83148-012_407bc1b6-5851-1b87-e063-6294a90a02da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone Butyrate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- The J. Molner Company LLC
- Application
- ANDA209556
- Marketing category
- ANDA
- Marketing start
- 2023-11-06
- Substance
- HYDROCORTISONE BUTYRATE
- Active strength
- 1 mg/mL
- 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
- Hydrocortisone Butyrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE BUTYRATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 05RMF7YPWN |
| Rxcui | 1370763 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83148-012-02 | Hydrocortisone Butyrate | 59 mL in 1 BOTTLE | LOTION | 59 | | 6 |
| 83148-012-02 | Hydrocortisone Butyrate | 1 in 1 CARTON | LOTION | 1 | | 6 |
| 83148-012-04 | Hydrocortisone Butyrate | 1 in 1 CARTON | LOTION | 1 | | 6 |
| 83148-012-04 | Hydrocortisone Butyrate | 118 mL in 1 BOTTLE | LOTION | 118 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83148-012 | HYDROCORTISONE BUTYRATE LOTION [THE J. MOLNER COMPANY LLC] | 5 | Current NDC, 4 package rows | 20241009_160c463e-80d2-4bca-8b7f-42279617e309.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83148-012-02 | 83148001202 | 1 BOTTLE in 1 CARTON (83148-012-02) / 59 mL in 1 BOTTLE | 1 bottle | 2023-11-06 | No | No | Current |
| 83148-012-04 | 83148001204 | 1 BOTTLE in 1 CARTON (83148-012-04) / 118 mL in 1 BOTTLE | 1 bottle | 2023-11-06 | No | No | Current |