Keranique 2% Hair Regrowth Treatment for Women
- Product NDC
- 70550-576
- 11-digit product format
- 705500576
- Labeler code
- 70550
- Product ID
- 70550-576_2046bd30-462c-4c46-e063-6294a90a8e59
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MINOXIDIL
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- PROFECTUS BEAUTY, LLC
- Application
- ANDA078176
- Marketing category
- ANDA
- Marketing start
- 2024-07-17
- Substance
- MINOXIDIL
- Active strength
- 20 mg/mL
- 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
- Keranique 2% Hair Regrowth Treatment for Women
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MINOXIDIL | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5965120SH1 |
| Rxcui | 311723 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70550-576-01 | Keranique 2% Hair Regrowth Treatment for Women | 1 in 1 BOX | SOLUTION | 1 | | 4 |
| 70550-576-01 | Keranique 2% Hair Regrowth Treatment for Women | 60 mL in 1 BOTTLE, DROPPER | SOLUTION | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70550-576 | KERANIQUE 2% HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL) SOLUTION [PROFECTUS BEAUTY, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240828_c781447a-10f1-70e3-e053-2995a90a40f8.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 |
|---|
| 70550-576-01 | 70550057601 | 1 BOTTLE, DROPPER in 1 BOX (70550-576-01) / 60 mL in 1 BOTTLE, DROPPER | 2024-07-17 | 0000-00-00 | No | No | Current |
| 70550-576-02 | 70550057602 | 2 BOTTLE, DROPPER in 1 BOX (70550-576-02) > 60 mL in 1 BOTTLE, DROPPER | 2021-07-20 | 0000-00-00 | No | No | Current |
| 70550-576-04 | 70550057604 | 4 BOTTLE, DROPPER in 1 BOX (70550-576-04) > 60 mL in 1 BOTTLE, DROPPER | 2021-07-20 | 0000-00-00 | No | No | Current |