Prescription drug · ANDA
Isoniazid NDC 0781-3056
Isoniazid 100 mg/mL · Injection, Solution · Intramuscular · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3056-70 | 00781305670 | 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3056-70) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 19, 2006 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040648
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-3056_66f2f4a4-1479-450c-8834-89cd29b08f2bSPL ID 66f2f4a4-1479-450c-8834-89cd29b08f2bSPL set ID 77795c31-1cdf-4a20-b4a1-cd15f5b310f1RxCUI 204430UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400781305670followed by a unit qualifier and the quantityPackage 00781-3056-70. 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 Injection USP is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant antituberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid, or any other medication, is inadequate therapy. Intramuscular administration is intended for use whenever administration by the oral route is not possible. 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 p…
Excerpt only. Read the full label for complete information.
About NDC 0781-3056
- What is NDC 0781-3056?
- 0781-3056 is the product NDC for Isoniazid, Isoniazid 100 mg/mL injection, solution, listed with the FDA by Sandoz Inc. 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?
- Sandoz Inc, NDC labeler code 0781. 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 | 67046-1617 | 67046-1617-03 |
| 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 |