What is NDC 62135-835?

62135-835 is the product NDC for Tinidazole, Tinidazole 500 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Chartwell RX, LLC, NDC labeler code 62135. 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 62135-835 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-835Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0835Add 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
62135-835-20	62135083520	20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)Marketed from Jul 5, 2024

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, Film coated
Route: Oral
Labeler: Chartwell RX, LLCNDC labeler code 62135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202044
Marketing start: Apr 30, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 62135-835_1d71c803-2d38-ccc8-e063-6294a90a7923SPL ID 1d71c803-2d38-ccc8-e063-6294a90a7923SPL set ID b39bc167-f1c4-4169-8b46-e6c2eafe6bbfRxCUI 199519, 477234UNII 033KF7V46HUPC 0362135834203, 0362135835200
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

N462135083520 followed by a unit qualifier and the quantity

Package 62135-0835-20. 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 Jul 17, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Tinidazole tablet 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 adult women ( 1.4 , 8.1 ) 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection [see Clinical Studies (14.1) ]. 1.2 Giardiasis Tinidazole is indicated for the treatment of g…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-835

What is NDC 62135-835?: 62135-835 is the product NDC for Tinidazole, Tinidazole 500 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC. 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?: Chartwell RX, LLC, NDC labeler code 62135. 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	Edenbridge Pharmaceuticals LLC.	42799-208	42799-0208-0142799-0208-02
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

Other NDCs under ANDA 202044

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

FDA NDC Directory listings under ANDA 202044
Product	Strength	Form · route	Labeler	Product NDC
Tinidazole	Tinidazole 250 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-550
Tinidazole	Tinidazole 500 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-551
Tinidazole	Tinidazole 250 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-834