PROCTOZONE-HC
- Product NDC
- 68788-7091
- 11-digit product format
- 687887091
- Labeler code
- 68788
- Product ID
- 68788-7091_5e0698b9-e95e-406d-8e43-d7583b62e19d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone 2.5%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA040879
- Marketing category
- ANDA
- Marketing start
- 2018-02-12
- Substance
- HYDROCORTISONE
- Active strength
- 25 mg/g
- 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
- PROCTOZONE-HC
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 310891, 1440936 |
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 |
|---|
| 68788-7091-3 | PROCTOZONE-HC | 30 g in 1 TUBE | CREAM | 30 | | 7 |
| 68788-7091-3 | PROCTOZONE-HC | 1 in 1 CARTON | CREAM | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7091 | PROCTOZONE-HC (HYDROCORTISONE 2.5%) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240805_5f055f94-b213-431b-897e-1c439660f158.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 |
|---|
| 68788-7091-3 | 68788709103 | 1 TUBE in 1 CARTON (68788-7091-3) / 30 g in 1 TUBE | 1 tube | 2018-02-12 | 0000-00-00 | No | No | Current |