HYDROCORTISONE BUTYRATE
- Product NDC
- 68682-392
- 11-digit product format
- 686820392
- Labeler code
- 68682
- Product ID
- 68682-392_2f38330f-dede-a2af-e063-6294a90a1a94
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCORTISONE BUTYRATE
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA022076
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-06-08
- 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 |
|---|
| 68682-392-02 | HYDROCORTISONE BUTYRATE | 1 in 1 CARTON | LOTION | 1 | | 5 |
| 68682-392-02 | HYDROCORTISONE BUTYRATE | 59 mL in 1 BOTTLE | LOTION | 59 | | 5 |
| 68682-392-04 | HYDROCORTISONE BUTYRATE | 118 mL in 1 BOTTLE | LOTION | 118 | | 5 |
| 68682-392-04 | HYDROCORTISONE BUTYRATE | 1 in 1 CARTON | LOTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68682-392 | HYDROCORTISONE BUTYRATE LOTION [OCEANSIDE PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250303_dde66620-657b-4b30-bd30-4bb6e83612cb.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 |
|---|
| 68682-392-02 | 68682039202 | 1 BOTTLE in 1 CARTON (68682-392-02) / 59 mL in 1 BOTTLE | 1 bottle | 2018-06-08 | 0000-00-00 | No | No | Current |
| 68682-392-04 | 68682039204 | 1 BOTTLE in 1 CARTON (68682-392-04) > 118 mL in 1 BOTTLE | 1 bottle | 2018-06-08 | 0000-00-00 | No | No | Current |