Prescription drug · ANDA
Isoniazid NDC 63187-978
Isoniazid 300 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-978-30 | 63187097830 | 30 TABLET in 1 BOTTLE (63187-978-30)Marketed from Feb 1, 2018 | |
| 63187-978-60 | 63187097860 | 60 TABLET in 1 BOTTLE (63187-978-60)Marketed from Feb 1, 2018 | |
| 63187-978-90 | 63187097890 | 90 TABLET in 1 BOTTLE (63187-978-90)Marketed from Feb 1, 2018 |
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
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080937
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-978_5c1e5064-9311-4161-a11f-1e006dd97bfbSPL ID 5c1e5064-9311-4161-a11f-1e006dd97bfbSPL set ID 65e50989-d24c-4bb3-a041-d6aea2635ef1RxCUI 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
N463187097830followed by a unit qualifier and the quantityPackage 63187-0978-30. 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 tablets 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 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): 1. Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 080937
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 | Teva Pharmaceuticals USA, Inc. | 0555-0071 |
| Isoniazid | Isoniazid 300 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4315 |
| 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 | Bryant Ranch Prepack | 71335-2760 |
| Isoniazid | Isoniazid 300 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-083 |
| Isoniazid | Isoniazid 300 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2800 |
| Isoniazid | Isoniazid 300 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-395 |
| Isoniazid | Isoniazid 300 mg/1 | TabletOral | A-S Medication Solutions | 50090-0370 |