NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1681Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1681Add 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
71335-1681-0713351681007133516810040 TABLET in 1 BOTTLE (71335-1681-0)Marketed from Oct 31, 2024
71335-1681-1713351681017133516810120 TABLET in 1 BOTTLE (71335-1681-1)Marketed from Aug 5, 2020
71335-1681-2713351681027133516810230 TABLET in 1 BOTTLE (71335-1681-2)Marketed from Aug 4, 2020
71335-1681-3713351681037133516810314 TABLET in 1 BOTTLE (71335-1681-3)Marketed from Aug 5, 2020
71335-1681-4713351681047133516810456 TABLET in 1 BOTTLE (71335-1681-4)Marketed from Oct 31, 2024
71335-1681-5713351681057133516810521 TABLET in 1 BOTTLE (71335-1681-5)Marketed from Aug 10, 2020
71335-1681-671335168106713351681064 TABLET in 1 BOTTLE (71335-1681-6)Marketed from Jul 12, 2021
71335-1681-7713351681077133516810728 TABLET in 1 BOTTLE (71335-1681-7)Marketed from Aug 31, 2020
71335-1681-87133516810871335168108100 TABLET in 1 BOTTLE (71335-1681-8)Marketed from Oct 31, 2024
71335-1681-9713351681097133516810960 TABLET in 1 BOTTLE (71335-1681-9)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 079067
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014SPL ID bf0721d6-e6ff-4afd-b09a-96fbcf8cc014SPL set ID 8522493d-0a18-49dd-8d49-bd159f6ee332RxCUI 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

N471335168100 followed by a unit qualifier and the quantity

Package 71335-1681-00. 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 USP 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 USP 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.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1681

What is NDC 71335-1681?
71335-1681 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 079067

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

FDA NDC Directory listings under ANDA 079067
ProductStrengthForm · routeLabelerProduct NDC
MetronidazoleMetronidazole 250 mg/1TabletOralAlembic Pharmaceuticals Limited46708-428
MetronidazoleMetronidazole 500 mg/1TabletOralAlembic Pharmaceuticals Limited46708-429
MetronidazoleMetronidazole 250 mg/1TabletOralAvPAK50268-534
MetronidazoleMetronidazole 500 mg/1TabletOralAvPAK50268-535
MetronidazoleMetronidazole 250 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-016
MetronidazoleMetronidazole 500 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-017
MetronidazoleMetronidazole 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2288
MetronidazoleMetronidazole 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5073
MetronidazoleMetronidazole 500 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-007
MetronidazoleMetronidazole 500 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-011

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