NDC codes

FDA NDC Directory
Product NDC (as listed)0781-3056Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-3056Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0781-3056-70007813056701 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.

How CPT relates to drug billing

NDC on a medical claim

N400781305670 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Isoniazid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
isoniazidIsoniazid 300 mg/1TabletOralREMEDYREPACK INC.70518-454070518-4540-0070518-4540-01
isoniazidIsoniazid 300 mg/1TabletOralCoupler LLC67046-161767046-1617-03
IsoniazidIsoniazid 300 mg/1TabletOralCoupler LLC67046-157067046-1570-03
IsoniazidIsoniazid 300 mg/1TabletOralREMEDYREPACK INC.70518-431570518-4315-0070518-4315-0170518-4315-02
isoniazidIsoniazid 100 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-80410135-0804-01
isoniazidIsoniazid 300 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-80510135-0805-0110135-0805-30
IsoniazidIsoniazid 100 mg/1TabletOralGenus Lifesciences64950-21664950-0216-10
IsoniazidIsoniazid 300 mg/1TabletOralGenus Lifesciences64950-21764950-0217-0364950-0217-10
IsoniazidIsoniazid 300 mg/1TabletOralBryant Ranch Prepack71335-276071335-2760-01
IsoniazidIsoniazid 300 mg/1TabletOralBryant Ranch Prepack71335-280071335-2800-0171335-2800-0271335-2800-03+2 more

All 27 Isoniazid NDCs

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