NDC codes

FDA NDC Directory
Product NDC (as listed)58657-939Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58657-0939Add 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
58657-939-015865709390158657093901100 BLISTER PACK in 1 CARTON (58657-939-01) / 1 TABLET in 1 BLISTER PACK (58657-939-10)Marketed from Jul 1, 2025
58657-939-03586570939035865709390330 BLISTER PACK in 1 CARTON (58657-939-03) / 1 TABLET in 1 BLISTER PACK (58657-939-10)Marketed from May 4, 2026
58657-939-05586570939055865709390550 BLISTER PACK in 1 CARTON (58657-939-05) / 1 TABLET in 1 BLISTER PACK (58657-939-10)Marketed from Jul 1, 2025

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)
metronidazole
Generic name (nonproprietary)
metronidazole
Active ingredients
Metronidazole — 125 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Method Pharmaceuticals LLCNDC labeler code 58657
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 070772
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 58657-939_51018185-a67f-bf2c-e063-6394a90adca5SPL ID 51018185-a67f-bf2c-e063-6394a90adca5SPL set ID 2ae49bf4-a23b-bdcc-e063-6294a90a80a9RxCUI 311681, 314106, 2702348UNII 140QMO216EUPC 0358657939038, 0358657739560, 0358657739010
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

N458657093901 followed by a unit qualifier and the quantity

Package 58657-0939-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Symptomatic Trichomoniasis. Metronidazole is 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 is 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. Treatment of Asymptomatic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58657-939

What is NDC 58657-939?
58657-939 is the product NDC for metronidazole, Metronidazole 125 mg/1 tablet, listed with the FDA by Method Pharmaceuticals LLC. It has 3 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?
Method Pharmaceuticals LLC, NDC labeler code 58657. 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 070772

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

FDA NDC Directory listings under ANDA 070772
ProductStrengthForm · routeLabelerProduct NDC
metronidazoleMetronidazole 500 mg/1TabletOralGolden State Medical Supply, Inc.51407-372
metronidazoleMetronidazole 250 mg/1TabletOralGolden State Medical Supply, Inc.51407-376
MetronidazoleMetronidazole 500 mg/1TabletOralCardinal Health 107, LLC55154-8190
metronidazoleMetronidazole 125 mg/1TabletOralMethod Pharmaceuticals LLC58657-739
metronidazoleMetronidazole 250 mg/1TabletOralMethod Pharmaceuticals LLC58657-933
metronidazoleMetronidazole 500 mg/1TabletOralMethod Pharmaceuticals LLC58657-934
MetronidazoleMetronidazole 250 mg/1TabletOralAmerican Health Packaging60687-526
MetronidazoleMetronidazole 500 mg/1TabletOralAmerican Health Packaging60687-550
metronidazoleMetronidazole 250 mg/1TabletOralAMICI PHARMA INC69292-207
metronidazoleMetronidazole 500 mg/1TabletOralAMICI PHARMA INC69292-208
metronidazoleMetronidazole 125 mg/1TabletOralBryant Ranch Prepack71335-2949
metronidazoleMetronidazole 125 mg/1TabletOralBryant Ranch Prepack72162-2468

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