KERANIQUE Hair Regrowth Treatment For Women
- Product NDC
- 70550-578
- 11-digit product format
- 705500578
- Labeler code
- 70550
- Product ID
- 70550-578_2046653c-a5e8-c010-e063-6294a90ae442
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MINOXIDIL
- Dosage form
- SPRAY
- 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 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 | 1537947 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70550-578-01 | KERANIQUE Hair Regrowth Treatment For Women | 60 mL in 1 BOTTLE, SPRAY | SPRAY | 60 | | 4 |
| 70550-578-01 | KERANIQUE Hair Regrowth Treatment For Women | 1 in 1 BOX | SPRAY | 1 | | 4 |
| 70550-578-02 | KERANIQUE Hair Regrowth Treatment For Women | 2 in 1 BOX | SPRAY | 2 | | 4 |
| 70550-578-02 | KERANIQUE Hair Regrowth Treatment For Women | 60 mL in 1 BOTTLE, SPRAY | SPRAY | 60 | | 4 |
| 70550-578-03 | KERANIQUE Hair Regrowth Treatment For Women | 3 in 1 BOX | SPRAY | 3 | | 4 |
| 70550-578-03 | KERANIQUE Hair Regrowth Treatment For Women | 60 mL in 1 BOTTLE, SPRAY | SPRAY | 60 | | 4 |
| 70550-578-04 | KERANIQUE Hair Regrowth Treatment For Women | 4 in 1 BOX | SPRAY | 4 | | 4 |
| 70550-578-04 | KERANIQUE Hair Regrowth Treatment For Women | 60 mL in 1 BOTTLE, SPRAY | SPRAY | 60 | | 4 |
| 70550-578-04 | KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN | 60 mL in 1 BOTTLE | SPRAY | 60 | | 1 |
| 70550-578-04 | KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN | 4 in 1 BOX | SPRAY | 4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70550-578 | KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL) SPRAY [PROFECTUS BEAUTY, LLC] | 4 | Current NDC, Legacy NDC, 8 package rows | 20240828_8d580c01-a13d-81f8-e053-2a95a90a7426.zip |
| 70550-578 | KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL 2%) SPRAY [PROFECTUS BEAUTY LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220915_d8dcf6f7-5b80-4b2c-e053-2995a90a87f2.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 |
|---|
| 70550-578-01 | 70550057801 | 1 BOTTLE, SPRAY in 1 BOX (70550-578-01) / 60 mL in 1 BOTTLE, SPRAY | 2024-07-17 | 0000-00-00 | No | No | Current |
| 70550-578-02 | 70550057802 | 2 BOTTLE, SPRAY in 1 BOX (70550-578-02) / 60 mL in 1 BOTTLE, SPRAY | 2024-07-17 | 0000-00-00 | No | No | Current |
| 70550-578-03 | 70550057803 | 3 BOTTLE, SPRAY in 1 BOX (70550-578-03) / 60 mL in 1 BOTTLE, SPRAY | 2024-07-17 | 0000-00-00 | No | No | Current |
| 70550-578-04 | 70550057804 | 4 BOTTLE, SPRAY in 1 BOX (70550-578-04) / 60 mL in 1 BOTTLE, SPRAY | 2024-07-17 | 0000-00-00 | No | No | Current |