Nateglinide NDC 55111-328

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-328Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0328Add 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
55111-328-01	55111032801	100 TABLET in 1 BOTTLE (55111-328-01)Marketed from Sep 9, 2009
55111-328-05	55111032805	500 TABLET in 1 BOTTLE (55111-328-05)Marketed from Sep 9, 2009
55111-328-30	55111032830	30 TABLET in 1 BOTTLE (55111-328-30)Marketed from Sep 9, 2009
55111-328-78	55111032878	10 BLISTER PACK in 1 CARTON (55111-328-78) / 10 TABLET in 1 BLISTER PACK (55111-328-79)Marketed from Sep 9, 2009
55111-328-90	55111032890	90 TABLET in 1 BOTTLE (55111-328-90)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 — 60 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077461
Marketing start: Sep 9, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Potassium Channel Antagonists (Mechanism)
Identifiers: Product ID 55111-328_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

N455111032801 followed by a unit qualifier and the quantity

Package 55111-0328-01. 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 27, 2021.

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 077461

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

FDA NDC Directory listings under ANDA 077461
Product	Strength	Form · route	Labeler	Product NDC
Nateglinide	Nateglinide 120 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-329