HYDROCORTISONE
- Product NDC
- 0115-1697
- 11-digit product format
- 001151697
- Labeler code
- 0115
- Product ID
- 0115-1697_f28149c1-c377-40ad-9d87-2f909eacf9e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA040646
- Marketing category
- ANDA
- Marketing start
- 2007-03-30
- Substance
- HYDROCORTISONE
- Active strength
- 10 mg/1
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 197782, 197783, 197787 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-1697-01 | HYDROCORTISONE | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1697 | HYDROCORTISONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240719_9fe627ad-4aba-4bd1-8590-6cc2d61674ba.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 |
|---|
| 0115-1697-01 | 00115169701 | 100 TABLET in 1 BOTTLE, PLASTIC (0115-1697-01) | 100 tablet | 2007-03-30 | 0000-00-00 | No | No | Current |