Hydrocortisone
- Product NDC
- 64380-970
- 11-digit product format
- 643800970
- Labeler code
- 64380
- Product ID
- 64380-970_e31ab65b-eef6-4d60-98fe-e2150a130b9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA207029
- Marketing category
- ANDA
- Marketing start
- 2020-09-25
- Substance
- HYDROCORTISONE
- Active strength
- 5 mg/1
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 197782, 197783, 197787 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 64380-970-25 | 2024-02-13 | C162847 | 48780-1 | 1030e365-4c67-111a-e063-dadaa90a10e2 | Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg |
| 64380-970-25 | 2024-02-13 | C162847 | 48780-1 | 1030e365-4c67-111a-e063-dadaa90a10e2 | Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg |
| 64380-970-25 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4c67-111a-e063-dadaa90a10e2 | Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg |
| 64380-970-25 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4c67-111a-e063-dadaa90a10e2 | Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-970-25 | Hydrocortisone | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-970 | HYDROCORTISONE TABLET [STRIDES PHARMA SCIENCE LIMITED] | 8 | Current NDC, Legacy NDC, 1 package rows | 20241205_90a46849-5b75-467b-9bc5-8f192d4d20d2.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 |
|---|
| 64380-970-25 | 64380097025 | 50 TABLET in 1 BOTTLE, PLASTIC (64380-970-25) | 50 tablet | 2020-09-25 | 0000-00-00 | No | No | Current |