Hydrocortisone
- Product NDC
- 71297-010
- 11-digit product format
- 712970010
- Labeler code
- 71297
- Product ID
- 71297-010_47e771ab-b850-724f-e063-6394a90ac63c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone Lotion
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Allegis Holdings LLC
- Application
- ANDA083231
- Marketing category
- ANDA
- Marketing start
- 2024-06-10
- Substance
- HYDROCORTISONE
- Active strength
- 20 mg/mL
- 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 197784 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71297-010-01 | Hydrocortisone | 1 in 1 BOX | LOTION | 1 | | 2 |
| 71297-010-01 | Hydrocortisone | 29.6 mL in 1 BOTTLE, WITH APPLICATOR | LOTION | 29.6 | | 2 |
| 71297-010-02 | Hydrocortisone | 59.2 mL in 1 BOTTLE, WITH APPLICATOR | LOTION | 59.2 | | 2 |
| 71297-010-02 | Hydrocortisone | 1 in 1 BOX | LOTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71297-010 | HYDROCORTISONE (HYDROCORTISONE LOTION) LOTION [ALLEGIS HOLDINGS LLC] | 1 | Current NDC, 4 package rows | 20240611_1a27d8fa-4025-ed68-e063-6394a90a4f37.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71297-010-01 | 71297001001 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-01) / 29.6 mL in 1 BOTTLE, WITH APPLICATOR | 2024-06-10 | No | No | Current |
| 71297-010-02 | 71297001002 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-02) / 59.2 mL in 1 BOTTLE, WITH APPLICATOR | 2024-06-10 | No | No | Current |