Prescription drug · ANDA
Fosaprepitant (fosaprepitant dimeglumine) NDC 16714-248
Fosaprepitant dimeglumine 150 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-248-01 | 16714024801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-248-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 28, 2023 |
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)
- Fosaprepitant
- Generic name (nonproprietary)
- fosaprepitant dimeglumine
- Active ingredients
- Fosaprepitant dimeglumine — 150 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214616
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Neurokinin 1 Antagonists (Mechanism)
- Identifiers
- Product ID 16714-248_014ef0ec-f371-ccc7-e063-6294a90a7349SPL ID 014ef0ec-f371-ccc7-e063-6294a90a7349SPL set ID df341f63-0fef-4411-a89b-6df6b9e792beRxCUI 1731077UNII D35FM8T64XUPC 0316714248011
- Pharmacologic class
- Substance P/Neurokinin-1 Receptor Antagonist
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
N416714024801followed by a unit qualifier and the quantityPackage 16714-0248-01. 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)
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. • delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use • Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting. Fosaprepitant for injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pediatric …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214616
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 |
|---|---|---|---|---|
| Fosaprepitantfosaprepitant dimeglumine | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | BluePoint Laboratories | 68001-523 |
| Fosaprepitantfosaprepitant dimeglumine | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Camber Pharmaceuticals, Inc. | 31722-165 |