What is NDC 51079-083?

51079-083 is the product NDC for Isoniazid, Isoniazid 300 mg/1 tablet, listed with the FDA by Mylan Institutional Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Institutional Inc., NDC labeler code 51079. 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 51079-083 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51079-083Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51079-0083Add 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
51079-083-20	5107900832051079008320	100 BLISTER PACK in 1 CARTON (51079-083-20) / 1 TABLET in 1 BLISTER PACK (51079-083-01)Marketed from Jun 9, 1994

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: Mylan Institutional Inc.NDC labeler code 51079
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 080937
Marketing start: Jun 9, 1994
Marketing end: Nov 30, 2026
Identifiers: Product ID 51079-083_2c63f06e-644c-83aa-e063-6394a90a879aSPL ID 2c63f06e-644c-83aa-e063-6394a90a879aSPL set ID 60a6b514-fa7f-4bc7-85b0-e5a14fa56b59RxCUI 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

N451079008320 followed by a unit qualifier and the quantity

Package 51079-0083-20. 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 Jan 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Isoniazid tablets, USP 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, USP 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51079-083

What is NDC 51079-083?: 51079-083 is the product NDC for Isoniazid, Isoniazid 300 mg/1 tablet, listed with the FDA by Mylan Institutional Inc.. 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?: Mylan Institutional Inc., NDC labeler code 51079. 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	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
Isoniazid	Isoniazid 300 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-395