Pramosone
- Product NDC
- 83107-021
- 11-digit product format
- 831070021
- Labeler code
- 83107
- Product ID
- 83107-021_3726846b-fa95-09cb-e063-6294a90a7bf7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone acetate and pramoxine hydrochloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Legacy Pharma USA Inc.
- Application
- ANDA085979
- Marketing category
- ANDA
- Marketing start
- 2025-05-27
- Substance
- HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 25; 10 mg/mL; mg/mL
- 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
- Pramosone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE ACETATE | 25 mg/mL |
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X7931PO74, 88AYB867L5 |
| Rxcui | 1234512, 1234514 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83107-021-02 | Pramosone | 59 mL in 1 BOTTLE, PLASTIC | LOTION | 59 | | 1 |
| 83107-021-04 | Pramosone | 118 mL in 1 BOTTLE, PLASTIC | LOTION | 118 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83107-021-02 | 83107002102 | 59 mL in 1 BOTTLE, PLASTIC (83107-021-02) | 59 ml | 2025-05-27 | No | No | Historical |
| 83107-021-04 | 83107002104 | 118 mL in 1 BOTTLE, PLASTIC (83107-021-04) | 118 ml | 2025-05-27 | No | No | Historical |