Prescription drug · ANDA
Tinidazole NDC 70518-4727
Tinidazole 500 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4727-0 | 70518472700 | 10 TABLET in 1 BOTTLE, PLASTIC (70518-4727-0)Marketed from Aug 18, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Tinidazole
- Generic name (nonproprietary)
- tinidazole
- Active ingredients
- Tinidazole — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203808
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 70518-4727_5965b16b-36e9-1b69-e063-6294a90a2bf0SPL ID 5965b16b-36e9-1b69-e063-6294a90a2bf0SPL set ID 7f552a9b-3190-4301-8352-36451a73b956RxCUI 199519UNII 033KF7V46H
- 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
N470518472700followed by a unit qualifier and the quantityPackage 70518-4727-00. 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 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 non-pregnant, 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 procedur…
Excerpt only. Read the full label for complete information.
About NDC 70518-4727
- What is NDC 70518-4727?
- 70518-4727 is the product NDC for Tinidazole, Tinidazole 500 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tinidazole.
- What is the active ingredient?
- Tinidazole.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tinidazole?
- 7 other product NDCs are listed under this name. See all Tinidazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tinidazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tinidazole | Tinidazole 500 mg/1 | Tablet, Film coatedOral | BioComp Pharma, Inc. | 44523-450 | 44523-0450-1244523-0450-20 |
| Tinidazole | Tinidazole 250 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-207 | 42799-0207-01 |
| Tinidazole | Tinidazole 500 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-208 | 42799-0208-0142799-0208-02 |
| Tinidazole | Tinidazole 250 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-834 | 62135-0834-20 |
| Tinidazole | Tinidazole 500 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-835 | 62135-0835-20 |
| Tinidazole | Tinidazole 250 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-550 | 43386-0550-04 |
| Tinidazole | Tinidazole 500 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-551 | 43386-0551-0243386-0551-06 |
Other NDCs under ANDA 203808
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 |
|---|---|---|---|---|
| Tinidazole | Tinidazole 250 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-207 |
| Tinidazole | Tinidazole 500 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-208 |