Miglitol
- Product NDC
- 69367-303
- 11-digit product format
- 693670303
- Labeler code
- 69367
- Product ID
- 69367-303_d28d00da-e102-098c-e053-2995a90a8121
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Miglitol
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA203965
- Marketing category
- ANDA
- Marketing start
- 2021-01-15
- Substance
- MIGLITOL
- Active strength
- 25 mg/1
- Pharmacologic classes
- alpha Glucosidase Inhibitors [MoA], alpha-Glucosidase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Miglitol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIGLITOL | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0V5436JAQW |
| Rxcui | 205329, 205330, 205331 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-303-01 | Miglitol | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-303 | MIGLITOL TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20211208_b8da2015-d254-2425-e053-2995a90acf0e.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 |
|---|
| 69367-303-01 | 69367030301 | 100 TABLET, COATED in 1 BOTTLE (69367-303-01) | 2021-01-15 | 0000-00-00 | No | No | Current |