Regoxidine
- Product NDC
- 57483-540
- 11-digit product format
- 574830540
- Labeler code
- 57483
- Product ID
- 57483-540_61359d4f-de10-41f1-a795-f2ae3bda5b1d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Minoxidil
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Innovus Pharmaceuticals, Inc.
- Application
- ANDA209074
- Marketing category
- ANDA
- Marketing start
- 2019-04-22
- Substance
- MINOXIDIL
- Active strength
- 50 mg/g
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Regoxidine
- Brand name suffix
- (For Women)
- Listing expiration
- 2026-12-31
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 |
|---|
| 57483-540-31 | Regoxidine (For Women) | 2 in 1 PACKAGE | AEROSOL, FOAM | 2 | | 3 |
| 57483-540-31 | Regoxidine (For Women) | 60 g in 1 CAN | AEROSOL, FOAM | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57483-540 | REGOXIDINE (FOR WOMEN) (MINOXIDIL) AEROSOL, FOAM [ INNOVUS PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221228_b60cc177-700c-4007-be1a-2cb74824e657.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 |
|---|
| 57483-540-31 | 57483054031 | 2 CAN in 1 PACKAGE (57483-540-31) / 60 g in 1 CAN | 2 can | 2019-11-12 | 0000-00-00 | No | No | Current |