NDC codes

FDA NDC Directory
Product NDC (as listed)62135-550Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0550Add 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
62135-550-4762135055047473 mL in 1 BOTTLE (62135-550-47)Marketed from May 10, 2023

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
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 081118
Marketing start
Listing expires
Identifiers
Product ID 62135-550_44fdc5f6-d8fc-49a1-e063-6394a90ad33cSPL ID 44fdc5f6-d8fc-49a1-e063-6394a90ad33cSPL set ID 8a6fa0b2-48e3-4c06-97c5-9ec3d6475a7cRxCUI 105292UNII V83O1VOZ8LUPC 0362135550479
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

N462135055047 followed by a unit qualifier and the quantity

Package 62135-0550-47. 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 parentheses): 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 62135-550

What is NDC 62135-550?
62135-550 is the product NDC for Isoniazid, Isoniazid 50 mg/5mL solution, listed with the FDA by Chartwell RX, LLC. 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?
Chartwell RX, LLC, NDC labeler code 62135. 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 300 mg/1TabletOralBryant Ranch Prepack71335-280071335-2800-0171335-2800-0271335-2800-03+2 more
IsoniazidIsoniazid 100 mg/1TabletOralBryant Ranch Prepack71335-308371335-3083-01
IsoniazidIsoniazid 100 mg/1TabletOralGenus Lifesciences64950-21664950-0216-10
IsoniazidIsoniazid 300 mg/1TabletOralGenus Lifesciences64950-21764950-0217-0364950-0217-10

All 27 Isoniazid NDCs

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