NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1922Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1922Add 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
71335-1922-0713351922007133519220040 TABLET in 1 BOTTLE (71335-1922-0)Marketed from Oct 31, 2024
71335-1922-1713351922017133519220120 TABLET in 1 BOTTLE (71335-1922-1)Marketed from Aug 11, 2021
71335-1922-2713351922027133519220230 TABLET in 1 BOTTLE (71335-1922-2)Marketed from Aug 26, 2021
71335-1922-3713351922037133519220314 TABLET in 1 BOTTLE (71335-1922-3)Marketed from Oct 7, 2021
71335-1922-4713351922047133519220456 TABLET in 1 BOTTLE (71335-1922-4)Marketed from Oct 31, 2024
71335-1922-5713351922057133519220521 TABLET in 1 BOTTLE (71335-1922-5)Marketed from Dec 9, 2021
71335-1922-671335192206713351922064 TABLET in 1 BOTTLE (71335-1922-6)Marketed from Oct 4, 2021
71335-1922-7713351922077133519220728 TABLET in 1 BOTTLE (71335-1922-7)Marketed from Aug 3, 2021
71335-1922-87133519220871335192208100 TABLET in 1 BOTTLE (71335-1922-8)Marketed from Oct 31, 2024
71335-1922-9713351922097133519220960 TABLET in 1 BOTTLE (71335-1922-9)Marketed from Oct 31, 2024

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 — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203974
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1SPL ID cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1SPL set ID 92e58420-1d99-4a92-b1f3-a7f791ca7187RxCUI 311681UNII 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

N471335192200 followed by a unit qualifier and the quantity

Package 71335-1922-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatme…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1922

What is NDC 71335-1922?
71335-1922 is the product NDC for Metronidazole, Metronidazole 500 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Metronidazole.
What is the active ingredient?
Metronidazole.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Metronidazole?
160 other product NDCs are listed under this name. See all Metronidazole NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Metronidazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MetronidazoleMetronidazole 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-476770518-4767-00
MetronidazoleMetronidazole 250 mg/1Tablet, Film coatedOralKanchan Healthcare Inc85742-02485742-0024-2485742-0024-25
MetronidazoleMetronidazole 500 mg/1Tablet, Film coatedOralKanchan Healthcare Inc85742-02585742-0025-2485742-0025-25
MetronidazoleMetronidazole 250 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-267772162-2677-0172162-2677-0272162-2677-05
MetronidazoleMetronidazole 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-267872162-2678-0172162-2678-0272162-2678-05
MetronidazoleMetronidazole 500 mg/1Tablet, Film coatedOralCoupler LLC67046-106067046-1060-03
MetronidazoleMetronidazole 500 mg/1Tablet, Film coatedOralCoupler LLC67046-117367046-1173-03
MetronidazoleMetronidazole 7.5 mg/gGelTopicalZydus Lifesciences Limited70771-197870771-1978-04
MetronidazoleMetronidazole 7.5 mg/gGelTopicalViona Pharmaceuticals Inc72578-20972578-0209-04
MetronidazoleMetronidazole 7.5 mg/gGelVaginalSolaris Pharma Corporation73473-30373473-0303-70

All 161 Metronidazole NDCs

Other NDCs under ANDA 203974

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

FDA NDC Directory listings under ANDA 203974
ProductStrengthForm · routeLabelerProduct NDC
MetronidazoleMetronidazole 500 mg/1TabletOralRising Pharma Holdings, Inc.16571-664
MetronidazoleMetronidazole 250 mg/1TabletOralRising Pharma Holdings, Inc.16571-665
MetronidazoleMetronidazole 250 mg/1TabletOralA-S Medication Solutions50090-5691
MetronidazoleMetronidazole 250 mg/1TabletOralAurobindo Pharma Limited65862-694
MetronidazoleMetronidazole 500 mg/1TabletOralAurobindo Pharma Limited65862-695
MetronidazoleMetronidazole 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2399
MetronidazoleMetronidazole 500 mg/1TabletOralREMEDYREPACK INC.70518-3110
MetronidazoleMetronidazole 250 mg/1TabletOralBryant Ranch Prepack71335-1838

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