Prescription drug · ANDA
Phytonadione NDC 69238-1051
Phytonadione 5 mg/1 · Tablet · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1051-1 | 69238105101 | 1 BOTTLE in 1 CARTON (69238-1051-1) / 100 TABLET in 1 BOTTLEMarketed from May 15, 2018 | |
| 69238-1051-3 | 69238105103 | 1 BOTTLE in 1 CARTON (69238-1051-3) / 30 TABLET in 1 BOTTLEMarketed from May 15, 2018 |
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
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209373
- Marketing start
- Listing expires
- Other FDA classes
- Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
- Identifiers
- Product ID 69238-1051_94d89db9-981d-4fc5-b6fe-5d4b73230e35SPL ID 94d89db9-981d-4fc5-b6fe-5d4b73230e35SPL set ID 54c1c1df-0e65-4da8-9023-6cbaa0f5bd0dRxCUI 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
N469238105101followed by a unit qualifier and the quantityPackage 69238-1051-01. 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 .
Indications (excerpt from the label)
Phytonadione tablets are indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives. Hypoprothrombinemia secondary to antibacterial therapy. Hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis. Other drug-induced hypoprothrombinemia where it is defi…
Excerpt only. Read the full label for complete information.
About NDC 69238-1051
- What is NDC 69238-1051?
- 69238-1051 is the product NDC for Phytonadione, Phytonadione 5 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 2 package NDCs, 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?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 5 mg/1 | TabletOral | Safecor Health, LLC | 48433-160 | 48433-0160-03 |
| 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 |
Other NDCs under ANDA 209373
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 | Major Pharmaceuticals | 0904-6882 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | American Health Packaging | 60687-381 |