What is NDC 81665-108?

81665-108 is the product NDC for isoniazid, Isoniazid 300 mg/1 tablet, listed with the FDA by OMNIVIUM PHARMACEUTICALS LLC.. It has 3 package NDCs, shown above in 10- and 11-digit form.

OMNIVIUM PHARMACEUTICALS LLC., NDC labeler code 81665. 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 81665-108 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)81665-108Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81665-0108Add 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
81665-108-10	8166501081081665010810	100 TABLET in 1 BOTTLE, PLASTIC (81665-108-10)Marketed from Oct 15, 2024
81665-108-30	8166501083081665010830	30 TABLET in 1 BOTTLE, PLASTIC (81665-108-30)Marketed from Oct 15, 2024
81665-108-51	8166501085181665010851	1000 TABLET in 1 BOTTLE, PLASTIC (81665-108-51)Marketed from Oct 15, 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): isoniazid
Generic name (nonproprietary): isoniazid
Active ingredients: Isoniazid — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: OMNIVIUM PHARMACEUTICALS LLC.NDC labeler code 81665
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040090
Marketing start: Oct 15, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 81665-108_3966e8ed-31f4-6d0a-e063-6294a90a3233SPL ID 3966e8ed-31f4-6d0a-e063-6294a90a3233SPL set ID 35400f1d-fd25-4bfa-a382-ac390e21bf2eRxCUI 197832, 311166UNII V83O1VOZ8LUPC 0381665108103, 0381665108301, 0381665107106, 0381665108516
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

N481665010810 followed by a unit qualifier and the quantity

Package 81665-0108-10. 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 8, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Isoniazid is 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 is 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 parentheses): 1. Persons with human immunodeficiency virus (HIV) infection (≥ 5 mm) and persons with risk factors for HIV i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 81665-108

What is NDC 81665-108?: 81665-108 is the product NDC for isoniazid, Isoniazid 300 mg/1 tablet, listed with the FDA by OMNIVIUM PHARMACEUTICALS LLC.. It has 3 package NDCs, 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?: OMNIVIUM PHARMACEUTICALS LLC., NDC labeler code 81665. 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 040090

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

FDA NDC Directory listings under ANDA 040090
Product	Strength	Form · route	Labeler	Product NDC
isoniazid	Isoniazid 100 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-804
isoniazid	Isoniazid 300 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-805
isoniazid	Isoniazid 300 mg/1	TabletOral	A-S Medication Solutions	50090-7660
isoniazid	Isoniazid 300 mg/1	TabletOral	Coupler LLC	67046-1617
isoniazid	Isoniazid 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-4540
isoniazid	Isoniazid 100 mg/1	TabletOral	Bryant Ranch Prepack	72162-2444
isoniazid	Isoniazid 300 mg/1	TabletOral	Bryant Ranch Prepack	72162-2445
isoniazid	Isoniazid 100 mg/1	TabletOral	OMNIVIUM PHARMACEUTICALS LLC.	81665-107