NDC codes

FDA NDC Directory
Product NDC (as listed)68071-5283Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-5283Add 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
68071-5283-86807152830828 TABLET in 1 BOTTLE, PLASTIC (68071-5283-8)Marketed from Jun 18, 2020

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 205245
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 68071-5283_2a307d1e-9ca1-c34a-e063-6294a90af55cSPL ID 2a307d1e-9ca1-c34a-e063-6294a90af55cSPL set ID a860b097-7447-a3b7-e053-2995a90a4bfdRxCUI 314106UNII 140QMO216EUPC 0368071528381
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

N468071528308 followed by a unit qualifier and the quantity

Package 68071-5283-08. 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 205245

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

FDA NDC Directory listings under ANDA 205245
ProductStrengthForm · routeLabelerProduct NDC
MetronidazoleMetronidazole 250 mg/1TabletOralNorthwind Health Company, LLC51655-974
MetronidazoleMetronidazole 500 mg/1TabletOralChartwell RX, LLC62135-796
MetronidazoleMetronidazole 250 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-651
MetronidazoleMetronidazole 250 mg/1TabletOralChartwell RX, LLC62135-795
MetronidazoleMetronidazole 500 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-652
MetronidazoleMetronidazole 250 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2251
MetronidazoleMetronidazole 500 mg/1TabletOralREMEDYREPACK INC.70518-3265
MetronidazoleMetronidazole 500 mg/1TabletOralMajor Pharmaceuticals0904-7126
MetronidazoleMetronidazole 250 mg/1TabletOralCardinal Health 107, LLC55154-2343
MetronidazoleMetronidazole 500 mg/1TabletOralNorthwind Health Company, LLC51655-441
MetronidazoleMetronidazole 250 mg/1TabletOralMajor Pharmaceuticals0904-7156

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