Prescription drug · ANDA
Tindazole (Tinidazole) NDC 64980-427
Tinidazole 500 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-427-12 | 64980042712 | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)Marketed from Oct 9, 2013 |
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)
- Tindazole
- Generic name (nonproprietary)
- tinidazole
- Active ingredients
- Tinidazole — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202489
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 64980-427_8dbd79dd-9243-4413-aa01-ba1301573a48SPL ID 8dbd79dd-9243-4413-aa01-ba1301573a48SPL set ID 32167dd7-5d37-457b-9b00-cd735de6b060RxCUI 199519, 477234UNII 033KF7V46HUPC 0364980426022
- Pharmacologic class
- Nitroimidazole Antimicrobial
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
N464980042712followed by a unit qualifier and the quantityPackage 64980-0427-12. 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)
Tinidazole Tablet is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in adult women ( 1.4, 8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.5) . 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Beca…
Excerpt only. Read the full label for complete information.
About NDC 64980-427
- What is NDC 64980-427?
- 64980-427 is the product NDC for Tindazole (tinidazole), Tinidazole 500 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tindazole (Tinidazole).
- What is the active ingredient?
- Tinidazole.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tindazole?
- 2 other product NDCs are listed under this name. See all Tindazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tindazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tindazoletinidazole | Tinidazole 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4172 | 70518-4172-00 |
| Tindazoletinidazole | Tinidazole 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-426 | 64980-0426-02 |
Other NDCs under ANDA 202489
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tindazoletinidazole | Tinidazole 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-426 |
| Tindazoletinidazole | Tinidazole 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4172 |