What is NDC 71610-395?

71610-395 is the product NDC for Isoniazid, Isoniazid 300 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Isoniazid?

26 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Isoniazid NDC 71610-395 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-395Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0395Add 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
71610-395-30	7161003953071610039530	30 TABLET in 1 BOTTLE, PLASTIC (71610-395-30)Marketed from Feb 21, 2020

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): Isoniazid
Generic name (nonproprietary): isoniazid
Active ingredients: Isoniazid — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 080937
Marketing start: Sep 1, 1972
Listing expires: Dec 31, 2026
Identifiers: Product ID 71610-395_10b9b8c8-0cfc-47b7-9324-bbd6f2617b5fSPL ID 10b9b8c8-0cfc-47b7-9324-bbd6f2617b5fSPL set ID cb6f5638-2d3a-4334-b272-6b4772d32d03RxCUI 197832UNII V83O1VOZ8L
Pharmacologic class: Antimycobacterial

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

N471610039530 followed by a unit qualifier and the quantity

Package 71610-0395-30. 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 Mar 23, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Isoniazid tablets are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-395

What is NDC 71610-395?: 71610-395 is the product NDC for Isoniazid, Isoniazid 300 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Isoniazid.
What is the active ingredient?: Isoniazid.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Isoniazid?: 26 other product NDCs are listed under this name. See all Isoniazid 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 Isoniazid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
isoniazid	Isoniazid 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-4540	70518-4540-0070518-4540-01
isoniazid	Isoniazid 300 mg/1	TabletOral	Coupler LLC	67046-1617	67046-1617-03
Isoniazid	Isoniazid 300 mg/1	TabletOral	Coupler LLC	67046-1570	67046-1570-03
Isoniazid	Isoniazid 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-4315	70518-4315-0070518-4315-0170518-4315-02
isoniazid	Isoniazid 100 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-804	10135-0804-01
isoniazid	Isoniazid 300 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-805	10135-0805-0110135-0805-30
Isoniazid	Isoniazid 100 mg/1	TabletOral	Genus Lifesciences	64950-216	64950-0216-10
Isoniazid	Isoniazid 300 mg/1	TabletOral	Genus Lifesciences	64950-217	64950-0217-0364950-0217-10
Isoniazid	Isoniazid 300 mg/1	TabletOral	Bryant Ranch Prepack	71335-2760	71335-2760-01
Isoniazid	Isoniazid 300 mg/1	TabletOral	Bryant Ranch Prepack	71335-2800	71335-2800-0171335-2800-0271335-2800-03+2 more

All 27 Isoniazid NDCs

Other NDCs under ANDA 080937

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

FDA NDC Directory listings under ANDA 080937
Product	Strength	Form · route	Labeler	Product NDC
Isoniazid	Isoniazid 300 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0071
Isoniazid	Isoniazid 300 mg/1	TabletOral	A-S Medication Solutions	50090-0370
Isoniazid	Isoniazid 300 mg/1	TabletOral	Mylan Institutional Inc.	51079-083
Isoniazid	Isoniazid 300 mg/1	TabletOral	Proficient Rx LP	63187-978
Isoniazid	Isoniazid 300 mg/1	TabletOral	Genus Lifesciences	64950-217
Isoniazid	Isoniazid 300 mg/1	TabletOral	Coupler LLC	67046-1570
Isoniazid	Isoniazid 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-4315
Isoniazid	Isoniazid 300 mg/1	TabletOral	Bryant Ranch Prepack	71335-2760
Isoniazid	Isoniazid 300 mg/1	TabletOral	Bryant Ranch Prepack	71335-2800