Prescription drug · ANDA
Isoniazid NDC 62135-550
Isoniazid 50 mg/5mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-550-47 | 62135055047 | 473 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
N462135055047followed by a unit qualifier and the quantityPackage 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.
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.
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 300 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2800 | 71335-2800-0171335-2800-0271335-2800-03+2 more |
| Isoniazid | Isoniazid 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3083 | 71335-3083-01 |
| 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 |