Prescription drug · ANDA
Phytonadione NDC 70771-1318
Phytonadione 5 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1318-1 | 70771131801 | 1 BOTTLE in 1 CARTON (70771-1318-1) / 100 TABLET in 1 BOTTLEMarketed from Feb 22, 2019 | |
| 70771-1318-3 | 70771131803 | 30 TABLET in 1 BOTTLE (70771-1318-3)Marketed from Nov 1, 2021 | |
| 70771-1318-4 | 70771131804 | 10 BLISTER PACK in 1 CARTON (70771-1318-4) / 10 TABLET in 1 BLISTER PACK (70771-1318-2)Marketed from Feb 22, 2019 |
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)
- Phytonadione
- Generic name (nonproprietary)
- phytonadione
- Active ingredients
- Phytonadione — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210189
- Marketing start
- Listing expires
- Other FDA classes
- Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
- Identifiers
- Product ID 70771-1318_40070531-4723-48f2-89b4-9efde4d1c71fSPL ID 40070531-4723-48f2-89b4-9efde4d1c71fSPL set ID fa26f747-c64e-4090-a0cf-de3d3d9b004cRxCUI 198102UNII A034SE7857
- Pharmacologic class
- Vitamin K; Warfarin Reversal Agent
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
N470771131801followed by a unit qualifier and the quantityPackage 70771-1318-01. 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 .
Other NDCs under ANDA 210189
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 |
|---|---|---|---|---|
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Safecor Health, LLC | 48433-160 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1014 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Northstar Rx LLC. | 16714-973 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Coupler LLC | 67046-1581 |