Prescription drug · ANDA
Nateglinide NDC 55111-329
Nateglinide 120 mg/1 · Tablet · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-329-01 | 5511103290155111032901 | 100 TABLET in 1 BOTTLE (55111-329-01)Marketed from Sep 9, 2009 | |
| 55111-329-05 | 5511103290555111032905 | 500 TABLET in 1 BOTTLE (55111-329-05)Marketed from Sep 9, 2009 | |
| 55111-329-30 | 5511103293055111032930 | 30 TABLET in 1 BOTTLE (55111-329-30)Marketed from Sep 9, 2009 | |
| 55111-329-78 | 5511103297855111032978 | 10 BLISTER PACK in 1 CARTON (55111-329-78) / 10 TABLET in 1 BLISTER PACK (55111-329-79)Marketed from Sep 9, 2009 |
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
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077461
- Marketing start
- Listing expires
- Other FDA classes
- Potassium Channel Antagonists (Mechanism)
- Identifiers
- Product ID 55111-329_4e11dea8-92ab-762e-9808-fad73bf42330SPL ID 4e11dea8-92ab-762e-9808-fad73bf42330SPL set ID f7b28951-76d2-cabd-64a1-b74aa225c6e9RxCUI 311919, 314142UNII 41X3PWK4O2UPC 0355111329909
- 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
N455111032901followed by a unit qualifier and the quantityPackage 55111-0329-01. 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 tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : Nateglinide tablets 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 55111-329
- What is NDC 55111-329?
- 55111-329 is the product NDC for Nateglinide, Nateglinide 120 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 4 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?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 120 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-168 | 64380-0168-0164380-0168-02 |
| 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 |
Other NDCs under ANDA 077461
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 | Dr. Reddy's Laboratories Limited | 55111-328 |