Prescription drug · ANDA
isoniazid NDC 67046-1617
Isoniazid 300 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1617-3 | 67046161703 | 30 TABLET in 1 BLISTER PACK (67046-1617-3)Marketed from Nov 24, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040090
- Marketing start
- Listing expires
- Identifiers
- Product ID 67046-1617_44592907-10af-c357-e063-6394a90a2751SPL ID 44592907-10af-c357-e063-6394a90a2751SPL set ID 44592c5c-d11c-148d-e063-6294a90ab35cRxCUI 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
N467046161703followed by a unit qualifier and the quantityPackage 67046-1617-03. 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 . 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.
About NDC 67046-1617
- What is NDC 67046-1617?
- 67046-1617 is the product NDC for isoniazid, Isoniazid 300 mg/1 tablet, listed with the FDA by Coupler 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?
- Coupler LLC, NDC labeler code 67046. 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.
Related NDCs: other isoniazid products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 67046-1570 | 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 |
| Isoniazid | Isoniazid 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3083 | 71335-3083-01 |
Other NDCs under ANDA 040090
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | 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 |