MINOXIDIL
- Product NDC
- 53489-387
- 11-digit product format
- 534890387
- Labeler code
- 53489
- Product ID
- 53489-387_4a668fcd-612e-6944-e063-6394a90a9e2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- minoxidil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA072709
- Marketing category
- ANDA
- Marketing start
- 1995-12-14
- Substance
- MINOXIDIL
- Active strength
- 10 mg/1
- 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
- MINOXIDIL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MINOXIDIL | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5965120SH1 |
| Rxcui | 197986, 197987 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53489-387-01 | MINOXIDIL | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 53489-387-03 | MINOXIDIL | 250 in 1 BOTTLE | TABLET | 250 | | 5 |
| 53489-387-05 | MINOXIDIL | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
| 53489-387-10 | MINOXIDIL | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| minoxidil | ACTIVE INGREDIENT | 5965120SH1 | MINOXIDIL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| minoxidil | ACTIVE MOIETY | 5965120SH1 | MINOXIDIL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| minoxidil | ACTIVE INGREDIENT | 5965120SH1 | MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] | 2 | |
| minoxidil | ACTIVE MOIETY | 5965120SH1 | MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] | 2 | |
| Anhydrous Lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] | 2 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] | 2 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] | 2 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] | 2 | |
| Sodium Starch Glycolate Type A Potato | INACTIVE INGREDIENT | 5856J3G2A2 | MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] | 2 | |
| MINOXIDIL | ACTIVE INGREDIENT | 5965120SH1 | MINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| minoxidil | ACTIVE MOIETY | 5965120SH1 | MINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53489-387 | MINOXIDIL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20171019_0354a7f5-5917-44dc-9963-411104008cb5.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 |
|---|
| 53489-387-01 | 53489038701 | 100 TABLET in 1 BOTTLE (53489-387-01) | 100 tablet | 1995-12-14 | 0000-00-00 | No | No | Current |
| 53489-387-03 | 53489038703 | 250 TABLET in 1 BOTTLE (53489-387-03) | 250 tablet | 1995-12-14 | 0000-00-00 | No | No | Current |
| 53489-387-05 | 53489038705 | 500 TABLET in 1 BOTTLE (53489-387-05) | 500 tablet | 1995-12-14 | 0000-00-00 | No | No | Current |
| 53489-387-10 | 53489038710 | 1000 TABLET in 1 BOTTLE (53489-387-10) | 1000 tablet | 1995-12-14 | 0000-00-00 | No | No | Current |