REGOXIDINE (FOR MEN)
- Product NDC
- 57483-165
- 11-digit product format
- 574830165
- Labeler code
- 57483
- Product ID
- 57483-165_7f6c711d-2ee7-46d5-8b2c-4cf643bff18e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MINOXIDIL
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- INNOVUS PHARMACEUTICALS, INC.
- Application
- ANDA218616
- Marketing category
- ANDA
- Marketing start
- 2025-05-03
- Substance
- MINOXIDIL
- Active strength
- 50 mg/g
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- REGOXIDINE (FOR MEN)
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MINOXIDIL | 50 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5965120SH1 |
| Rxcui | 645146, 2264763 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57483-165-01 | REGOXIDINE (FOR MEN) | 60 g in 1 CAN | AEROSOL, FOAM | 60 | | 3 |
| 57483-165-11 | REGOXIDINE (FOR MEN) | 1 in 1 CARTON | AEROSOL, FOAM | 1 | | 3 |
| 57483-165-13 | REGOXIDINE (FOR MEN) | 3 in 1 CARTON | AEROSOL, FOAM | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57483-165 | REGOXIDINE (FOR MEN) (MINOXIDIL) AEROSOL, FOAM [INNOVUS PHARMACEUTICALS, INC.] | 1 | Current NDC, 3 package rows | 20250507_d191b3a9-0fb7-45cc-82a1-b64a79c0c125.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57483-165-01 | 57483016501 | 60 g in 1 CAN | 60 g | | | | Historical |
| 57483-165-11 | 57483016511 | 1 CAN in 1 CARTON (57483-165-11) / 60 g in 1 CAN (57483-165-01) | 1 can | 2025-11-14 | No | No | Current |
| 57483-165-13 | 57483016513 | 3 CAN in 1 CARTON (57483-165-13) / 60 g in 1 CAN (57483-165-01) | 3 can | 2025-05-03 | No | No | Current |