What is NDC 10135-804?

10135-804 is the product NDC for isoniazid, Isoniazid 100 mg/1 tablet, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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 10135-804 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)10135-804Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10135-0804Add 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
10135-804-01	1013508040110135080401	100 TABLET in 1 BOTTLE, PLASTIC (10135-804-01)Marketed from Mar 1, 2025

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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Marlex Pharmaceuticals, Inc.NDC labeler code 10135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040090
Marketing start: Mar 1, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 10135-804_3e871908-abb7-9d35-e063-6394a90ac63dSPL ID 3e871908-abb7-9d35-e063-6394a90ac63dSPL set ID 312cd403-b211-64ef-e063-6394a90aab88RxCUI 197832, 311166UNII 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

N410135080401 followed by a unit qualifier and the quantity

Package 10135-0804-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 10135-804

What is NDC 10135-804?: 10135-804 is the product NDC for isoniazid, Isoniazid 100 mg/1 tablet, listed with the FDA by Marlex Pharmaceuticals, 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?: Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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 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
Isoniazid	Isoniazid 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-3083	71335-3083-01

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 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
isoniazid	Isoniazid 300 mg/1	TabletOral	OMNIVIUM PHARMACEUTICALS LLC.	81665-108