Prescription drug · ANDA
Acarbose NDC 0054-0142
Acarbose 100 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0142-25 | 00054014225 | 100 TABLET in 1 BOTTLE (0054-0142-25)Marketed from May 7, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Acarbose
- Generic name (nonproprietary)
- acarbose
- Active ingredients
- Acarbose — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078470
- Marketing start
- Listing expires
- Other FDA classes
- alpha Glucosidase Inhibitors (Mechanism)
- Identifiers
- Product ID 0054-0142_2d7f6918-65c3-4db3-b775-b74e1e637ceaSPL ID 2d7f6918-65c3-4db3-b775-b74e1e637ceaSPL set ID 352dd336-d3f9-4ac5-a000-91d3aef7aca3RxCUI 199149, 199150, 200132UNII T58MSI464GUPC 0300540140250
- 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
N400054014225followed by a unit qualifier and the quantityPackage 00054-0142-25. 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 078470
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 | Hikma Pharmaceuticals USA Inc. | 0054-0141 |
| Acarbose | Acarbose 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-132 |
| Acarbose | Acarbose 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-131 |
| Acarbose | Acarbose 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-133 |
| Acarbose | Acarbose 25 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0140 |