NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4727Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4727Add 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
70518-4727-07051847270010 TABLET in 1 BOTTLE, PLASTIC (70518-4727-0)Marketed from Aug 18, 2026

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)
Tinidazole
Generic name (nonproprietary)
tinidazole
Active ingredients
Tinidazole — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203808
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 70518-4727_5965b16b-36e9-1b69-e063-6294a90a2bf0SPL ID 5965b16b-36e9-1b69-e063-6294a90a2bf0SPL set ID 7f552a9b-3190-4301-8352-36451a73b956RxCUI 199519UNII 033KF7V46H
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

N470518472700 followed by a unit qualifier and the quantity

Package 70518-4727-00. 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)

Tinidazole is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in non-pregnant, adult women ( 1.4 , 8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of tinidazole tablets and other antibacterial drugs, tinidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.5) 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis . The organism should be identified by appropriate diagnostic procedur…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-4727

What is NDC 70518-4727?
70518-4727 is the product NDC for Tinidazole, Tinidazole 500 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tinidazole.
What is the active ingredient?
Tinidazole.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tinidazole?
7 other product NDCs are listed under this name. See all Tinidazole 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 Tinidazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TinidazoleTinidazole 500 mg/1Tablet, Film coatedOralBioComp Pharma, Inc.44523-45044523-0450-1244523-0450-20
TinidazoleTinidazole 250 mg/1TabletOralEdenbridge Pharmaceuticals LLC.42799-20742799-0207-01
TinidazoleTinidazole 500 mg/1TabletOralEdenbridge Pharmaceuticals LLC.42799-20842799-0208-0142799-0208-02
TinidazoleTinidazole 250 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-83462135-0834-20
TinidazoleTinidazole 500 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-83562135-0835-20
TinidazoleTinidazole 250 mg/1TabletOralLupin Pharmaceuticals,Inc.43386-55043386-0550-04
TinidazoleTinidazole 500 mg/1TabletOralLupin Pharmaceuticals,Inc.43386-55143386-0551-0243386-0551-06

Other NDCs under ANDA 203808

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

FDA NDC Directory listings under ANDA 203808
ProductStrengthForm · routeLabelerProduct NDC
TinidazoleTinidazole 250 mg/1TabletOralEdenbridge Pharmaceuticals LLC.42799-207
TinidazoleTinidazole 500 mg/1TabletOralEdenbridge Pharmaceuticals LLC.42799-208

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