Hydrocortisone
- Product NDC
- 68788-9922
- 11-digit product format
- 687889922
- Labeler code
- 68788
- Product ID
- 68788-9922_9ec71cb7-3d50-487d-a4cd-04c9b8f000b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA085025
- Marketing category
- ANDA
- Marketing start
- 2012-01-27
- 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 | 310891 |
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 |
|---|
| 68788-9922-2 | Hydrocortisone | 28 g in 1 TUBE | CREAM | 28 | | 13 |
| 68788-9922-2 | Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9922 | HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240522_058bb2ff-ff51-4a3b-ba47-cb02272d0631.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 |
|---|
| 68788-9922-2 | 68788992202 | 1 TUBE in 1 CARTON (68788-9922-2) / 28 g in 1 TUBE | 1 tube | 2012-01-27 | 0000-00-00 | No | No | Current |
| 68788-9922-3 | 68788992203 | 1 TUBE in 1 CARTON (68788-9922-3) > 20 g in 1 TUBE | 1 tube | 2017-05-08 | 0000-00-00 | No | No | Current |