Prescription drug · ANDA
Isoniazid NDC 46287-009
Isoniazid 50 mg/5mL · Solution · Oral · CMP Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46287-009-01 | 46287000901 | 473 mL in 1 BOTTLE (46287-009-01)Marketed from Nov 11, 1983 |
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 — 50 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- CMP Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088235
- Marketing start
- Listing expires
- Identifiers
- Product ID 46287-009_b4455fa7-39e3-41a5-9a5b-5ff7c490de89SPL ID b4455fa7-39e3-41a5-9a5b-5ff7c490de89SPL set ID db8a3ae7-fb5b-47a9-a9f7-f57cd90501c2RxCUI 105292UNII 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
N446287000901followed by a unit qualifier and the quantityPackage 46287-0009-01. 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 oral solution 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 oral solution 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 parenthesis): Persons with human immunodeficiency virus (HIV) infection (greater than or equal t…
Excerpt only. Read the full label for complete information.