What is NDC 46287-009?

46287-009 is the product NDC for Isoniazid, Isoniazid 50 mg/5mL solution, listed with the FDA by CMP Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

CMP Pharma, Inc., NDC labeler code 46287. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Isoniazid NDC 46287-009 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46287-009Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46287-0009Add 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 NDC	11-digit (billing)	Package	Copy
46287-009-01	4628700090146287000901	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.NDC labeler code 46287
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 088235
Marketing start: Nov 11, 1983
Listing expires: Dec 31, 2026
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

N446287000901 followed by a unit qualifier and the quantity

Package 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 Nov 7, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 46287-009

What is NDC 46287-009?: 46287-009 is the product NDC for Isoniazid, Isoniazid 50 mg/5mL solution, listed with the FDA by CMP Pharma, 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?: CMP Pharma, Inc., NDC labeler code 46287. 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
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

All 27 Isoniazid NDCs