Prescription drug · ANDA
Fosaprepitant (Fosaprepitant dimeglumine) NDC 83634-776
Fosaprepitant dimeglumine 150 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Avenacy, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83634-776-10 | 8363407761083634077610 | 1 VIAL in 1 CARTON (83634-776-10) / 5 mL in 1 VIALMarketed from Feb 28, 2024 |
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
- Avenacy, LLCNDC labeler code 83634
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212143
- 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 83634-776_243b704e-ea10-4e4e-97dc-56b532be7f7bSPL ID 243b704e-ea10-4e4e-97dc-56b532be7f7bSPL set ID 3f942e4c-e26a-4155-9e14-344b2970b189RxCUI 1731077UNII D35FM8T64X
- 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
N483634077610followed by a unit qualifier and the quantityPackage 83634-0776-10. 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 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 patients 6 months of…
Excerpt only. Read the full label for complete information.
About NDC 83634-776
- What is NDC 83634-776?
- 83634-776 is the product NDC for Fosaprepitant (fosaprepitant dimeglumine), Fosaprepitant dimeglumine 150 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Avenacy, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fosaprepitant (Fosaprepitant dimeglumine).
- What is the active ingredient?
- Fosaprepitant dimeglumine.
- Who is the labeler?
- Avenacy, LLC, NDC labeler code 83634. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fosaprepitant?
- 18 other product NDCs are listed under this name. See all Fosaprepitant NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fosaprepitant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fosaprepitant | Fosaprepitant dimeglumine 150 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Dr. Reddy's Laboratories Inc., | 43598-671 | 43598-0671-11 |
| Fosaprepitant | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | BluePoint Laboratories | 68001-675 | 68001-0675-25 |
| Fosaprepitantfosaprepitant dimeglumine | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | NorthStar RxLLC | 16714-248 | 16714-0248-01 |
| Fosaprepitantfosaprepitant dimeglumine | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | BluePoint Laboratories | 68001-523 | 68001-0523-36 |
| Fosaprepitantfosaprepitant dimeglumine | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Camber Pharmaceuticals, Inc. | 31722-165 | 31722-0165-31 |
| Fosaprepitantfosaprepitant dimeglumine | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 71731-5111 | 71731-5111-01 |
| Fosaprepitant | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Dr. Reddy's Laboratories Inc., | 43598-948 | 43598-0948-11 |
| Fosaprepitant | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Bryant Ranch Prepack | 72162-2636 | 72162-2636-02 |
| Fosaprepitant | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Novadoz Pharmaceuticals LLC | 72205-054 | 72205-0054-01 |
| Fosaprepitant | Fosaprepitant dimeglumine 150 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Novadoz Pharmaceuticals LLC | 72205-083 | 72205-0083-01 |
Other NDCs under ANDA 212143
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 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 71731-5111 |