HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE
- Product NDC
- 75834-197
- 11-digit product format
- 758340197
- Labeler code
- 75834
- Product ID
- 75834-197_53ac723b-1f67-47e5-b560-6589342a27d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PRAMOXINE HYDROCHLORIDE and HYDROCORTISONE ACETATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Nivagen Pharmaceuticals Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2019-04-29
- Substance
- HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 25; 10 mg/g; 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
- HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE ACETATE | 25 mg/g |
| PRAMOXINE HYDROCHLORIDE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X7931PO74, 88AYB867L5 |
| Rxcui | 1294025 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-197-01 | HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE | 28.5 g in 1 TUBE, WITH APPLICATOR | CREAM | 28.5 | | 3 |
| 75834-197-01 | HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE | 1 in 1 CARTON | CREAM | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-197 | HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) CREAM [NIVAGEN PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230113_dc7f17e4-76f8-4cd4-a7e3-43032b386b74.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75834-197-01 | 75834019701 | 1 TUBE, WITH APPLICATOR in 1 CARTON (75834-197-01) / 28.5 g in 1 TUBE, WITH APPLICATOR | 2019-04-29 | 0000-00-00 | No | No | Current |