Hydrocortisone
- Product NDC
- 0316-0193
- 11-digit product format
- 003160193
- Labeler code
- 0316
- Product ID
- 0316-0193_48343bf7-453f-6b2e-e063-6394a90a05f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Crown Laboratories
- Application
- ANDA080706
- Marketing category
- ANDA
- Marketing start
- 2016-01-06
- 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 | 106258, 310891 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0316-0193-16 | 2023-02-13 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-16 | 2023-02-13 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-16 | 2023-02-13 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-20 | 2023-02-13 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-20 | 2023-02-13 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-20 | 2023-02-13 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-30 | 2023-02-13 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-30 | 2023-02-13 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-30 | 2023-02-13 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-16 | 2023-01-30 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-16 | 2023-01-30 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-16 | 2023-01-30 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
| 0316-0193-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-a7b6-0266-e053-dadaa90a7c1a | Hydrocortisone Cream USP, 1%, 2.5% |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0316-0193 | HYDROCORTISONE CREAM [CROWN LABORATORIES] | 20 | Current NDC, Legacy NDC, 6 package rows | 20231025_a84830ad-73dc-4a2e-b987-0a1103526535.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 |
|---|
| 0316-0193-16 | 00316019316 | 1 JAR in 1 CARTON (0316-0193-16) / 454 g in 1 JAR | 1 jar | 2016-01-06 | 0000-00-00 | No | No | Current |
| 0316-0193-20 | 00316019320 | 1 TUBE in 1 CARTON (0316-0193-20) / 20 g in 1 TUBE | 1 tube | 2016-01-06 | 0000-00-00 | No | No | Current |
| 0316-0193-30 | 00316019330 | 1 TUBE in 1 CARTON (0316-0193-30) / 30 g in 1 TUBE | 1 tube | 2016-01-06 | 0000-00-00 | No | No | Current |