What is NDC 42799-208?

42799-208 is the product NDC for Tinidazole, Tinidazole 500 mg/1 tablet, listed with the FDA by Edenbridge Pharmaceuticals LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tinidazole NDC 42799-208 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42799-208Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42799-0208Add 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 NDC	11-digit (billing)	Package	Copy
42799-208-01	42799020801	20 TABLET in 1 BOTTLE (42799-208-01)Marketed from Dec 20, 2019
42799-208-02	42799020802	60 TABLET in 1 BOTTLE (42799-208-02)Marketed from Dec 20, 2019

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): Tinidazole
Generic name (nonproprietary): tinidazole
Active ingredients: Tinidazole — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Edenbridge Pharmaceuticals LLC.NDC labeler code 42799
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203808
Marketing start: Dec 20, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 42799-208_462f7240-9709-4782-e063-6294a90a9e28SPL ID 462f7240-9709-4782-e063-6294a90a9e28SPL set ID 6f3ce597-64c1-4204-a67a-8b6f6e7e8bcaRxCUI 199519, 477234UNII 033KF7V46HUPC 0342799207018, 0342799208015
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

N442799020801 followed by a unit qualifier and the quantity

Package 42799-0208-01. 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 Dec 17, 2025. 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 42799-208

What is NDC 42799-208?: 42799-208 is the product NDC for Tinidazole, Tinidazole 500 mg/1 tablet, listed with the FDA by Edenbridge Pharmaceuticals LLC.. It has 2 package NDCs, 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?: Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tinidazole	Tinidazole 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4727	70518-4727-00
Tinidazole	Tinidazole 500 mg/1	Tablet, Film coatedOral	BioComp Pharma, Inc.	44523-450	44523-0450-1244523-0450-20
Tinidazole	Tinidazole 250 mg/1	TabletOral	Edenbridge Pharmaceuticals LLC.	42799-207	42799-0207-01
Tinidazole	Tinidazole 500 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-551	43386-0551-0243386-0551-06
Tinidazole	Tinidazole 250 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-550	43386-0550-04
Tinidazole	Tinidazole 250 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-834	62135-0834-20
Tinidazole	Tinidazole 500 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-835	62135-0835-20

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
Product	Strength	Form · route	Labeler	Product NDC
Tinidazole	Tinidazole 250 mg/1	TabletOral	Edenbridge Pharmaceuticals LLC.	42799-207
Tinidazole	Tinidazole 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4727