Hydrocortisone
- Product NDC
- 0168-0080
- 11-digit product format
- 001680080
- Labeler code
- 0168
- Product ID
- 0168-0080_d4641721-bb32-4cf7-b17f-78886ffbce17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Application
- ANDA089414
- Marketing category
- ANDA
- Marketing start
- 1986-12-16
- Substance
- HYDROCORTISONE
- Active strength
- 25 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocortisone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 103401, 310891 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0168-0080-16 | Hydrocortisone | 454 g in 1 JAR | CREAM | 454 | | 12 |
| 0168-0080-31 | Hydrocortisone | 30 g in 1 TUBE | CREAM | 30 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0080 | HYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241204_bcd103f3-3dc8-4394-b8fd-8f8ddb721f77.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 |
|---|
| 0168-0080-16 | 00168008016 | 454 g in 1 JAR (0168-0080-16) | 454 g | 1996-12-16 | 0000-00-00 | No | No | Current |
| 0168-0080-31 | 00168008031 | 30 g in 1 TUBE (0168-0080-31) | 30 g | 1986-12-16 | 0000-00-00 | No | No | Current |