Prescription drug · ANDA
Nateglinide NDC 51407-657
Nateglinide 120 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-657-01 | 51407065701 | 100 TABLET in 1 BOTTLE, PLASTIC (51407-657-01)Marketed from May 25, 2022 |
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)
- Nateglinide
- Generic name (nonproprietary)
- nateglinide
- Active ingredients
- Nateglinide — 120 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077463
- Marketing start
- Listing expires
- Other FDA classes
- Potassium Channel Antagonists (Mechanism)
- Identifiers
- Product ID 51407-657_32d5f62e-f2d1-8327-e063-6294a90a91d9SPL ID 32d5f62e-f2d1-8327-e063-6294a90a91d9SPL set ID e920b343-f53e-7487-e053-2995a90a719aRxCUI 311919, 314142UNII 41X3PWK4O2
- Pharmacologic class
- Glinide
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
N451407065701followed by a unit qualifier and the quantityPackage 51407-0657-01. 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)
Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Nateglinide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Nateglinide is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Limitations of Use : Not for treating type 1 diabetes mellitus or diabetes ketoacidosis (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077463
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 |
|---|---|---|---|---|
| Nateglinide | Nateglinide 60 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-167 |
| Nateglinide | Nateglinide 120 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-168 |
| Nateglinide | Nateglinide 60 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-656 |
| Nateglinide | Nateglinide 60 mg/1 | TabletOral | American Health Packaging | 60687-673 |
| Nateglinide | Nateglinide 120 mg/1 | TabletOral | American Health Packaging | 60687-684 |