Prescription drug · ANDA
Metronidazole NDC 63629-1388
Metronidazole 250 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1388-0 | 63629138800 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-0)Marketed from Sep 14, 2017 | |
| 63629-1388-1 | 63629138801 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-1)Marketed from Sep 4, 2024 | |
| 63629-1388-2 | 63629138802 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-2)Marketed from Sep 4, 2024 | |
| 63629-1388-3 | 63629138803 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-3)Marketed from Sep 4, 2024 | |
| 63629-1388-4 | 63629138804 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-4)Marketed from Sep 4, 2024 | |
| 63629-1388-5 | 63629138805 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-5)Marketed from Sep 4, 2024 | |
| 63629-1388-6 | 63629138806 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-6)Marketed from Sep 4, 2024 | |
| 63629-1388-7 | 63629138807 | 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-7)Marketed from Sep 4, 2024 | |
| 63629-1388-8 | 63629138808 | 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-8)Marketed from Mar 6, 2018 | |
| 63629-1388-9 | 63629138809 | 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-9)Marketed from Sep 4, 2024 |
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)
- Metronidazole
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203458
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8SPL ID e2a4bade-0163-4eed-8887-2fa27de3e0b8SPL set ID 8e1f507b-22fa-4033-9b3e-5435f20ace66RxCUI 314106UNII 140QMO216E
- 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
N463629138800followed by a unit qualifier and the quantityPackage 63629-1388-00. 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)
INDICATIONS AND USAGE Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatme…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203458
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 |
|---|---|---|---|---|
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-005 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-1876 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-6960 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2640 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3039 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0358 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 61919-032 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2305 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-226 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-227 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2280 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | PharmPak, Inc. | 54348-740 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | PharmPak, Inc. | 54348-745 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-827 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2152 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8674 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1536 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1060 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Quality Care Products LLC | 55700-298 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-365 |
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