Prescription drug · ANDA
Miglitol NDC 71205-937
Miglitol 100 mg/1 · Tablet, Coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-937-00 | 71205093700 | 100 TABLET, COATED in 1 BOTTLE (71205-937-00)Marketed from Mar 1, 2021 | |
| 71205-937-30 | 71205093730 | 30 TABLET, COATED in 1 BOTTLE (71205-937-30)Marketed from Mar 1, 2021 | |
| 71205-937-60 | 71205093760 | 60 TABLET, COATED in 1 BOTTLE (71205-937-60)Marketed from Mar 1, 2021 | |
| 71205-937-90 | 71205093790 | 90 TABLET, COATED in 1 BOTTLE (71205-937-90)Marketed from Mar 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Miglitol
- Generic name (nonproprietary)
- miglitol
- Active ingredients
- Miglitol — 100 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203965
- Marketing start
- Listing expires
- Other FDA classes
- alpha Glucosidase Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-937_c8003a86-3d92-4acb-b8b8-fe52835c83f5SPL ID c8003a86-3d92-4acb-b8b8-fe52835c83f5SPL set ID f16ecb50-e54e-43e1-8789-eaf5bc94f332RxCUI 205329, 205330, 205331UNII 0V5436JAQWUPC 0371205935306
- Pharmacologic class
- alpha-Glucosidase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471205093700followed by a unit qualifier and the quantityPackage 71205-0937-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203965
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Miglitol | Miglitol 50 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-304 |
| Miglitol | Miglitol 25 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-303 |
| Miglitol | Miglitol 100 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-305 |
| Miglitol | Miglitol 25 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 71205-935 |
| Miglitol | Miglitol 50 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 71205-936 |