Prescription drug · ANDA
Nateglinide NDC 64380-168
Nateglinide 120 mg/1 · Tablet · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-168-01 | 6438001680164380016801 | 100 TABLET in 1 BOTTLE, PLASTIC (64380-168-01)Marketed from May 9, 2022 | |
| 64380-168-02 | 6438001680264380016802 | 90 TABLET in 1 BOTTLE, PLASTIC (64380-168-02)Marketed from Sep 7, 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
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- 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 64380-168_774c246f-3d18-40d4-882f-4786d9382883SPL ID 774c246f-3d18-40d4-882f-4786d9382883SPL set ID 0ccf9b07-3c21-482d-abeb-a06ceb482c7bRxCUI 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
N464380016801followed by a unit qualifier and the quantityPackage 64380-0168-01. 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.
About NDC 64380-168
- What is NDC 64380-168?
- 64380-168 is the product NDC for Nateglinide, Nateglinide 120 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nateglinide.
- What is the active ingredient?
- Nateglinide.
- Who is the labeler?
- Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nateglinide?
- 17 other product NDCs are listed under this name. See all Nateglinide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nateglinide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nateglinide | Nateglinide 60 mg/1 | TabletOral | American Health Packaging | 60687-673 | 60687-0673-21 |
| Nateglinide | Nateglinide 120 mg/1 | TabletOral | American Health Packaging | 60687-684 | 60687-0684-21 |
| Nateglinide | Nateglinide 60 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-167 | 64380-0167-0164380-0167-02 |
| Nateglinide | Nateglinide 60 mg/1 | Tablet, CoatedOral | Modavar Pharmaceuticals LLC | 72241-002 | 72241-0002-0472241-0002-05 |
| Nateglinide | Nateglinide 120 mg/1 | Tablet, CoatedOral | Modavar Pharmaceuticals LLC | 72241-003 | 72241-0003-0472241-0003-05 |
| Nateglinide | Nateglinide 60 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-758 | 16571-0758-0116571-0758-0916571-0758-50 |
| Nateglinide | Nateglinide 120 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-759 | 16571-0759-0116571-0759-0916571-0759-50 |
| Nateglinide | Nateglinide 60 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-721 | 68382-0721-0168382-0721-0568382-0721-06+3 more |
| Nateglinide | Nateglinide 120 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-722 | 68382-0722-0168382-0722-0568382-0722-06+3 more |
| Nateglinide | Nateglinide 60 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1015 | 70771-1015-0070771-1015-0170771-1015-03+3 more |
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 | Golden State Medical Supply, Inc. | 51407-656 |
| Nateglinide | Nateglinide 120 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-657 |
| Nateglinide | Nateglinide 60 mg/1 | TabletOral | American Health Packaging | 60687-673 |
| Nateglinide | Nateglinide 120 mg/1 | TabletOral | American Health Packaging | 60687-684 |
| Nateglinide | Nateglinide 60 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-167 |