Nateglinide NDC 68382-721

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-721Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0721Add 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
68382-721-01	68382072101	100 TABLET, FILM COATED in 1 BOTTLE (68382-721-01)Marketed from Oct 27, 2016
68382-721-05	68382072105	500 TABLET, FILM COATED in 1 BOTTLE (68382-721-05)Marketed from Oct 27, 2016
68382-721-06	68382072106	30 TABLET, FILM COATED in 1 BOTTLE (68382-721-06)Marketed from Oct 27, 2016
68382-721-10	68382072110	1000 TABLET, FILM COATED in 1 BOTTLE (68382-721-10)Marketed from Oct 27, 2016
68382-721-16	68382072116	90 TABLET, FILM COATED in 1 BOTTLE (68382-721-16)Marketed from Oct 27, 2016
68382-721-77	68382072177	10 BLISTER PACK in 1 CARTON (68382-721-77) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 27, 2016

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 — 60 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.
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 68382-721_061a2260-2804-4753-b443-17943eca74ddSPL ID 061a2260-2804-4753-b443-17943eca74ddSPL set ID 88698921-cd8f-4d41-96e6-ff671913c5c3RxCUI 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

N468382072101 followed by a unit qualifier and the quantity

Package 68382-0721-01. 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 Nov 7, 2023.

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.

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 120 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1016
Nateglinide	Nateglinide 120 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-722