Fosaprepitant

Product NDC: 72606-569
11-digit product format: 726060569
Labeler code: 72606
Product ID: 72606-569_2a06acc8-1aed-4c6b-b02e-94ead42ae1fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosaprepitant Dimeglumine
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: CELLTRION USA, INC.
Application: ANDA211624
Marketing category: ANDA
Marketing start: 2020-03-01
Marketing end: 0000-00-00
Substance: FOSAPREPITANT DIMEGLUMINE
Active strength: 150 mg/5mL
Pharmacologic classes: Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72606-569-01	2025-03-13	C162847	48780-1	d6a99b39-8789-a426-e053-dadaa90af4c2	47177d8c-389f-46e8-aadf-5b69ceaeaf8b
72606-569-01	2022-01-28	C162847	48780-1	d6a99b39-8789-a426-e053-dadaa90af4c2	47177d8c-389f-46e8-aadf-5b69ceaeaf8b

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72606-569-01	EA - Each	72606-569	dd113043-9a0a-4c90-95d0-6efc9d3c6257	1	2020-04-20

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D35FM8T64X	FOSAPREPITANT DIMEGLUMINE	265121-04-8	FOSAPREPITANT DIMEGLUMINE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72606-569-01	72606056901	1 VIAL, SINGLE-DOSE in 1 CARTON (72606-569-01) > 5 mL in 1 VIAL, SINGLE-DOSE	2020-03-01	0000-00-00	No	No	Current