Prescription drug · ANDA
Acarbose NDC 63629-5698
Acarbose 50 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-5698-1 | 63629569801 | 30 TABLET in 1 BOTTLE (63629-5698-1)Marketed from Dec 10, 2016 | |
| 63629-5698-2 | 63629569802 | 90 TABLET in 1 BOTTLE (63629-5698-2)Marketed from Dec 10, 2016 | |
| 63629-5698-3 | 63629569803 | 100 TABLET in 1 BOTTLE (63629-5698-3)Marketed from Dec 10, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Acarbose
- Generic name (nonproprietary)
- acarbose
- Active ingredients
- Acarbose — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090912
- Marketing start
- Listing expires
- Other FDA classes
- alpha Glucosidase Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-5698_539553ec-baa9-4e89-ae74-81515af2c7b8SPL ID 539553ec-baa9-4e89-ae74-81515af2c7b8SPL set ID 1ba7a072-03b0-41f2-be7a-101145bdef3aRxCUI 199149, 200132UNII T58MSI464G
- 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
N463629569801followed by a unit qualifier and the quantityPackage 63629-5698-01. 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 Acarbose 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 090912
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 |
|---|---|---|---|---|
| Acarbose | Acarbose 50 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-759 |
| Acarbose | Acarbose 25 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-758 |
| Acarbose | Acarbose 100 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-760 |