Prescription drug · ANDA
Phytonadione NDC 48433-160
Phytonadione 5 mg/1 · Tablet · Oral · Safecor Health, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-160-03 | 48433016003 | 30 BLISTER PACK in 1 CARTON (48433-160-03) / 1 TABLET in 1 BLISTER PACK (48433-160-01)Marketed from Sep 2, 2026 · Sample package |
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)
- Phytonadione
- Generic name (nonproprietary)
- phytonadione
- Active ingredients
- Phytonadione — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Safecor Health, LLCNDC labeler code 48433
- 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 48433-160_5b25d1a6-2150-e44e-e063-6394a90a8892SPL ID 5b25d1a6-2150-e44e-e063-6394a90a8892
- 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
N448433016003followed by a unit qualifier and the quantityPackage 48433-0160-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 48433-160
- What is NDC 48433-160?
- 48433-160 is the product NDC for Phytonadione, Phytonadione 5 mg/1 tablet, listed with the FDA by Safecor Health, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phytonadione.
- What is the active ingredient?
- Phytonadione.
- Who is the labeler?
- Safecor Health, LLC, NDC labeler code 48433. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phytonadione?
- 31 other product NDCs are listed under this name. See all Phytonadione NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phytonadione products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Sun Pharmaceutical Industries, Inc. | 70095-154 | 70095-0154-02 |
| Phytonadione | Phytonadione 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Amneal Pharmaceuticals Private Limited | 80830-1683 | 80830-1683-03 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Orbicular Pharmaceutical Technologies Private Limited | 81607-020 | 81607-0020-02 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Baxter Healthcare Corporation | 43066-132 | 43066-0132-10 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Sagent Pharmaceuticals | 25021-505 | 25021-0505-70 |
| phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Amneal Pharmaceuticals LLC | 70121-1682 | 70121-1682-07 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Alembic Pharmaceuticals Limited | 46708-826 | 46708-0826-0546708-0826-10 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-826 | 62332-0826-0562332-0826-10 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Coupler LLC | 67046-1581 | 67046-1581-03 |
| Phytonadione | Phytonadione 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Xiromed LLC | 70700-331 | 70700-0331-25 |
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 | Northstar Rx LLC. | 16714-973 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Coupler LLC | 67046-1581 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1014 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1318 |