Nateglinide NDC 70771-1016

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1016Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
70771-1016-0	70771101600	1000 TABLET, FILM COATED in 1 BOTTLE (70771-1016-0)Marketed from Oct 27, 2016
70771-1016-1	70771101601	100 TABLET, FILM COATED in 1 BOTTLE (70771-1016-1)Marketed from Oct 27, 2016
70771-1016-3	70771101603	30 TABLET, FILM COATED in 1 BOTTLE (70771-1016-3)Marketed from Oct 27, 2016
70771-1016-4	70771101604	10 BLISTER PACK in 1 CARTON (70771-1016-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1016-2)Marketed from Oct 27, 2016
70771-1016-5	70771101605	500 TABLET, FILM COATED in 1 BOTTLE (70771-1016-5)Marketed from Oct 27, 2016
70771-1016-9	70771101609	90 TABLET, FILM COATED in 1 BOTTLE (70771-1016-9)Marketed from Oct 27, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
Route: Oral
Labeler: Zydus Lifesciences Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205248
Marketing start: Oct 27, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Potassium Channel Antagonists (Mechanism)
Identifiers: Product ID 70771-1016_58be95eb-5701-463e-b80c-eb9b6c2a789dSPL ID 58be95eb-5701-463e-b80c-eb9b6c2a789dSPL set ID a82817dd-f8c4-4172-ba86-63c2beef456aRxCUI 311919, 314142UNII 41X3PWK4O2UPC 0368382722164
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

N470771101600 followed by a unit qualifier and the quantity

Package 70771-1016-00. 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 Dec 3, 2024.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205248

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205248
Product	Strength	Form · route	Labeler	Product NDC
Nateglinide	Nateglinide 60 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1015
Nateglinide	Nateglinide 60 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-721
Nateglinide	Nateglinide 120 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-722