Prescription drug · ANDA
Vitamin K1 (Phytonadione) NDC 0409-9157
Phytonadione 2 mg/mL · Injection, Emulsion · Intramuscular, Intravenous, Subcutaneous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-9157-01 | 0040991570100409915701 | 5 TRAY in 1 CONTAINER (0409-9157-01) / 5 AMPULE in 1 TRAY (0409-9157-50) / .5 mL in 1 AMPULE (0409-9157-31)Marketed from Jun 22, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Vitamin K1
- Generic name (nonproprietary)
- phytonadione
- Active ingredients
- Phytonadione — 2 mg/mL
- Dosage form
- Injection, Emulsion
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Hospira, Inc.NDC labeler code 0409
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087954
- Marketing start
- Listing expires
- Other FDA classes
- Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
- Identifiers
- Product ID 0409-9157_689ec2ad-01a2-43bb-82f4-ac5cf0d91313SPL ID 689ec2ad-01a2-43bb-82f4-ac5cf0d91313SPL set ID e8808230-2c44-44c6-8cab-8f29b6b34051RxCUI 312424, 1670192UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400409915701followed by a unit qualifier and the quantityPackage 00409-9157-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Vitamin K 1 Injection is a vitamin K replacement indicated for the treatment of 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 deficiency caused by coumarin or indanedione derivatives. ( 1.1 ) • Hypoprothrombinemia due to antibacterial therapy. ( 1.1 ) • Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis. ( 1.1 ) • Other d…
Excerpt only. Read the full label for complete information.
About NDC 0409-9157
- What is NDC 0409-9157?
- 0409-9157 is the product NDC for Vitamin K1 (phytonadione), Phytonadione 2 mg/mL injection, emulsion, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vitamin K1 (Phytonadione).
- What is the active ingredient?
- Phytonadione.
- Who is the labeler?
- Hospira, Inc., NDC labeler code 0409. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vitamin K1?
- 1 other product NDC are listed under this name. See all Vitamin K1 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vitamin K1 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vitamin K1phytonadione | Phytonadione 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Hospira, Inc. | 0409-9158 | 00409-9158-0100409-9158-25 |
Other NDCs under ANDA 087954
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 |
|---|---|---|---|---|
| Vitamin K1 Phytonadionevitamin k1, phytonadione | Phytonadione 2 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1537 |