Prescription drug · ANDA
Isoniazid NDC 64950-216
Isoniazid 100 mg/1 · Tablet · Oral · Genus Lifesciences
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64950-216-10 | 64950021610 | 100 TABLET in 1 BOTTLE (64950-216-10)Marketed from Nov 1, 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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Genus Lifesciences
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080936
- Marketing start
- Marketing end
- Identifiers
- Product ID 64950-216_6ea58bc8-a5a8-47a1-81e1-f769924e1502SPL ID 6ea58bc8-a5a8-47a1-81e1-f769924e1502SPL set ID f0b46d1d-2300-457d-a7bd-a88a3f8d2235RxCUI 197832, 311166UNII V83O1VOZ8LUPC 0364950217100, 0364950216103
- 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
N464950021610followed by a unit qualifier and the quantityPackage 64950-0216-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Isoniazid tablets, USP 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, USP 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): Persons with human immunodeficiency virus (HIV) infection (greater than or equal …
Excerpt only. Read the full label for complete information.