Hydrocortisone Butyrate
- Product NDC
- 68682-271
- 11-digit product format
- 686820271
- Labeler code
- 68682
- Product ID
- 68682-271_01f93fa6-5fea-4b3e-aa41-e8e0269257ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone butyrate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA018652
- Marketing category
- NDA
- Marketing start
- 2009-09-01
- Substance
- HYDROCORTISONE BUTYRATE
- 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
- Hydrocortisone Butyrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE BUTYRATE | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 05RMF7YPWN |
| Rxcui | 1370758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68682-271-15 | Hydrocortisone Butyrate | 1 in 1 CARTON | OINTMENT | 1 | | 3 |
| 68682-271-15 | Hydrocortisone Butyrate | 15 g in 1 TUBE | OINTMENT | 15 | | 3 |
| 68682-271-45 | Hydrocortisone Butyrate | 1 in 1 CARTON | OINTMENT | 1 | | 3 |
| 68682-271-45 | Hydrocortisone Butyrate | 45 g in 1 TUBE | OINTMENT | 45 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68682-271 | HYDROCORTISONE BUTYRATE OINTMENT [OCEANSIDE PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 4 package rows | 20210205_7c3f8417-7861-41e3-876f-9b82aff7d1a0.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 |
|---|
| 68682-271-15 | 68682027115 | 1 TUBE in 1 CARTON (68682-271-15) / 15 g in 1 TUBE | 1 tube | 2009-09-01 | 0000-00-00 | No | No | Current |
| 68682-271-45 | 68682027145 | 1 TUBE in 1 CARTON (68682-271-45) / 45 g in 1 TUBE | 1 tube | 2009-09-01 | 0000-00-00 | No | No | Current |