hydrocortisone
- Product NDC
- 0168-0015
- 11-digit product format
- 001680015
- Labeler code
- 0168
- Product ID
- 0168-0015_22f122cb-16bd-422b-b4d0-bdba8f0b43d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Application
- ANDA080693
- Marketing category
- ANDA
- Marketing start
- 1976-04-30
- Substance
- HYDROCORTISONE
- Active strength
- 10 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 | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 106258 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0168-0015-16 | hydrocortisone | 453.6 g in 1 JAR | CREAM | 453.6 | | 6 |
| 0168-0015-31 | hydrocortisone | 28.35 g in 1 TUBE | CREAM | 28.35 | | 6 |
| 0168-0015-31 | hydrocortisone | 1 in 1 CARTON | CREAM | 1 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0015 | HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20241204_bc374fa4-ac8b-408e-9321-8bab97a18770.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 |
|---|
| 0168-0015-16 | 00168001516 | 453.6 g in 1 JAR (0168-0015-16) | 453.6 g | 1976-04-30 | 0000-00-00 | No | No | Current |
| 0168-0015-31 | 00168001531 | 1 TUBE in 1 CARTON (0168-0015-31) / 28.35 g in 1 TUBE | 1 tube | 1976-04-30 | 0000-00-00 | No | No | Current |