Prescription drug · ANDA
Isoniazid NDC 62135-709
Isoniazid 300 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-709-90 | 6213507099062135070990 | 90 TABLET in 1 BOTTLE (62135-709-90)Marketed from Oct 20, 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 — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089776
- Marketing start
- Listing expires
- Identifiers
- Product ID 62135-709_2df7a936-6840-66cc-e063-6294a90ae096SPL ID 2df7a936-6840-66cc-e063-6294a90ae096SPL set ID 2e09b1a5-9786-427f-bf00-be15b06eb7e7RxCUI 197832UNII V83O1VOZ8LUPC 0362135709907
- 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
N462135070990followed by a unit qualifier and the quantityPackage 62135-0709-90. 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 Tablets are 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 Tablets are 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 to 5 mm) a…
Excerpt only. Read the full label for complete information.
About NDC 62135-709
- What is NDC 62135-709?
- 62135-709 is the product NDC for Isoniazid, Isoniazid 300 mg/1 tablet, 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 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 |