FOCINVEZ

Product NDC: 82449-231
11-digit product format: 824490231
Labeler code: 82449
Product ID: 82449-231_4e50b25f-abb3-dcb2-e063-6394a90a2517
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FOSAPREPITANT DIMEGLUMINE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Steriscience Specialties Private Limited
Application: NDA216686
Marketing category: NDA
Marketing start: 2024-06-26
Substance: FOSAPREPITANT DIMEGLUMINE
Active strength: 150 mg/50mL
Pharmacologic classes: Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
FOSAPREPITANT DIMEGLUMINE	150 mg/50mL

Field, Values table
Field	Values
Unii	D35FM8T64X
Rxcui	2664065, 2664071

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2abc3e32-ae1f-4dec-be1c-0c39ac95b38e	Product name	7	20240514
5d352eda-d4de-4572-9a3f-32d6fd204f9a	Product name	1	20230911
3a5d67cc-4a03-45a3-8d74-5aeb67631be4	Product name	1	20230831
85fc66a9-58b2-e194-7cdb-89ff44dcf3e6	Product name	4	20210518
9f9a82fd-fcee-442f-9233-7f2d2f9f4568	Product name	1	20180108

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82449-231-01	FOCINVEZ	1 in 1 CARTON	INJECTION	1		5
82449-231-01	FOCINVEZ	50 mL in 1 VIAL, SINGLE-DOSE	INJECTION	50		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82449-231	FOCINVEZ (FOSAPREPITANT DIMEGLUMINE) INJECTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED]	2	Current NDC, 2 package rows	20241205_18a60093-cec8-1b8c-e063-6394a90a8902.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2664071	FOCINVEZ 150 MG in 50 ML Injection	PSN	18a60093-cec8-1b8c-e063-6394a90a8902	5
2664065	fosaprepitant 150 MG in 50 ML Injection	PSN	18a60093-cec8-1b8c-e063-6394a90a8902	5
2664071	50 ML fosaprepitant 3 MG/ML Injection [Focinvez]	SBD	18a60093-cec8-1b8c-e063-6394a90a8902	5
2664065	50 ML fosaprepitant 3 MG/ML Injection	SCD	18a60093-cec8-1b8c-e063-6394a90a8902	5
2664071	50 ML Focinvez 3 MG/ML Injection	SY	18a60093-cec8-1b8c-e063-6394a90a8902	5
2664071	Focinvez 150 MG per 50 ML Injection	SY	18a60093-cec8-1b8c-e063-6394a90a8902	5
2664065	fosaprepitant 150 MG per 50 ML Injection	SY	18a60093-cec8-1b8c-e063-6394a90a8902	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82449-231-01	82449023101	1 VIAL, SINGLE-DOSE in 1 CARTON (82449-231-01) / 50 mL in 1 VIAL, SINGLE-DOSE	2024-06-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FOCINVEZ	Steriscience Specialties Private Limited \| Steriscience Pte. Limited \| Onesource Specialty Pharma Limited \| STERISCIENCE SP Z O O	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	5