Prescription drug · ANDA
isoniazid NDC 10135-805
Isoniazid 300 mg/1 · Tablet · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-805-01 | 10135080501 | 100 TABLET in 1 BOTTLE, PLASTIC (10135-805-01)Marketed from Mar 1, 2025 | |
| 10135-805-30 | 10135080530 | 30 TABLET in 1 BOTTLE, PLASTIC (10135-805-30)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 — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040090
- Marketing start
- Listing expires
- Identifiers
- Product ID 10135-805_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
N410135080501followed by a unit qualifier and the quantityPackage 10135-0805-01. 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
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.
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 300 mg/1 | TabletOral | A-S Medication Solutions | 50090-7660 |
| isoniazid | Isoniazid 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2444 |
| isoniazid | Isoniazid 300 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2445 |
| isoniazid | Isoniazid 300 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4540 |
| isoniazid | Isoniazid 100 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-804 |
| isoniazid | Isoniazid 300 mg/1 | TabletOral | Coupler LLC | 67046-1617 |
| isoniazid | Isoniazid 100 mg/1 | TabletOral | OMNIVIUM PHARMACEUTICALS LLC. | 81665-107 |
| isoniazid | Isoniazid 300 mg/1 | TabletOral | OMNIVIUM PHARMACEUTICALS LLC. | 81665-108 |