What is NDC 43386-550?

43386-550 is the product NDC for Tinidazole, Tinidazole 250 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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 43386-550 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-550Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0550Add 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
43386-550-04	43386055004	40 TABLET in 1 BOTTLE (43386-550-04)Marketed from Apr 30, 2012

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 — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
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 43386-550_98a66e10-fb32-46ce-a68b-c21d615f6621SPL ID 98a66e10-fb32-46ce-a68b-c21d615f6621SPL set ID 95ab57b2-5d7e-4986-abcd-65edf1728383RxCUI 199519, 477234UNII 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

N443386055004 followed by a unit qualifier and the quantity

Package 43386-0550-04. 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 Feb 14, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Tinidazole Tablets 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 ) 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 tinidazole tablets 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 diagnos…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43386-550

What is NDC 43386-550?: 43386-550 is the product NDC for Tinidazole, Tinidazole 250 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,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?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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 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
Tinidazole	Tinidazole 500 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-551	43386-0551-0243386-0551-06

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	Tablet, Film coatedOral	Chartwell RX, LLC	62135-834
Tinidazole	Tinidazole 500 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-835
Tinidazole	Tinidazole 500 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-551