NDC codes

FDA NDC Directory
Product NDC (as listed)70518-0013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-0013Add 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
70518-0013-07051800130028 TABLET in 1 BOTTLE, PLASTIC (70518-0013-0)Marketed from Nov 23, 2016

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 70518-0013_4cd30b6f-08a5-b06a-e063-6294a90a8cffSPL ID 4cd30b6f-08a5-b06a-e063-6294a90a8cffSPL set ID ca450fad-0513-4c45-8ea0-1f46bcbf6a36RxCUI 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

N470518001300 followed by a unit qualifier and the quantity

Package 70518-0013-00. 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. Treatment…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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/1TabletOralBryant Ranch Prepack71335-0858
MetronidazoleMetronidazole 250 mg/1TabletOralProficient Rx LP63187-511
MetronidazoleMetronidazole 250 mg/1TabletOralTeva Pharmaceuticals USA, Inc.50111-333

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