NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0858Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0858Add 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 NDC11-digit (billing)PackageCopy
71335-0858-0713350858007 TABLET in 1 BOTTLE (71335-0858-0)Marketed from Aug 9, 2024
71335-0858-17133508580121 TABLET in 1 BOTTLE (71335-0858-1)Marketed from May 13, 2019
71335-0858-27133508580230 TABLET in 1 BOTTLE (71335-0858-2)Marketed from Dec 26, 2019
71335-0858-37133508580320 TABLET in 1 BOTTLE (71335-0858-3)Marketed from Aug 9, 2024
71335-0858-47133508580460 TABLET in 1 BOTTLE (71335-0858-4)Marketed from Aug 9, 2024
71335-0858-57133508580528 TABLET in 1 BOTTLE (71335-0858-5)Marketed from Aug 9, 2024
71335-0858-67133508580614 TABLET in 1 BOTTLE (71335-0858-6)Marketed from Aug 9, 2024
71335-0858-77133508580740 TABLET in 1 BOTTLE (71335-0858-7)Marketed from Aug 9, 2024
71335-0858-87133508580842 TABLET in 1 BOTTLE (71335-0858-8)Marketed from Aug 9, 2024
71335-0858-97133508580956 TABLET in 1 BOTTLE (71335-0858-9)Marketed from Aug 6, 2018

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)
Metronidazole
Generic name (nonproprietary)
metronidazole
Active ingredients
Metronidazole — 250 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 070027
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2SPL ID ac72621d-0d70-448b-b53c-903c6fdb7ee2SPL set ID ea635d05-b3c1-4f49-ace2-d091c20920daRxCUI 314106UNII 140QMO216E
Pharmacologic class
Nitroimidazole Antimicrobial

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

N471335085800 followed by a unit qualifier and the quantity

Package 71335-0858-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 070027

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

FDA NDC Directory listings under ANDA 070027
ProductStrengthForm · routeLabelerProduct NDC
MetronidazoleMetronidazole 250 mg/1TabletOralProficient Rx LP63187-511
MetronidazoleMetronidazole 250 mg/1TabletOralTeva Pharmaceuticals USA, Inc.50111-333
MetronidazoleMetronidazole 250 mg/1TabletOralREMEDYREPACK INC.70518-0013

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