Prescription drug · ANDA
Acarbose NDC 62135-455
Acarbose 100 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-455-90 | 62135045590 | 90 TABLET in 1 BOTTLE (62135-455-90)Marketed from Jan 31, 2023 |
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)
- Acarbose
- Generic name (nonproprietary)
- acarbose
- Active ingredients
- Acarbose — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202271
- Marketing start
- Listing expires
- Other FDA classes
- alpha Glucosidase Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-455_458bb3c6-f92c-cf49-e063-6294a90a96c2SPL ID 458bb3c6-f92c-cf49-e063-6294a90a96c2SPL set ID d1b627e1-d78d-47dd-93f5-2bf4998466baRxCUI 199149, 199150, 200132UNII T58MSI464GUPC 0362135453909, 0362135455903, 0362135454906
- 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
N462135045590followed by a unit qualifier and the quantityPackage 62135-0455-90. 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, USP 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 202271
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 100 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-149 |
| Acarbose | Acarbose 25 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-147 |
| Acarbose | Acarbose 50 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-148 |
| Acarbose | Acarbose 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9725 |
| Acarbose | Acarbose 25 mg/1 | TabletOral | Chartwell RX, LLC | 62135-453 |
| Acarbose | Acarbose 50 mg/1 | TabletOral | Chartwell RX, LLC | 62135-454 |