Flumazenil

Product NDC: 0641-6031
11-digit product format: 006416031
Labeler code: 0641
Product ID: 0641-6031_d441809f-34f5-4ad8-ad17-9f224aa329ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flumazenil
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: West-ward Pharmaceutical Corp.
Application: ANDA076787
Marketing category: ANDA
Marketing start: 2004-10-12
Marketing end: 0000-00-00
Substance: FLUMAZENIL
Active strength: 0 mg/mL
Pharmacologic classes: Benzodiazepine Antagonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0641-6031-10	2019-11-13	C162847	48780-1	97449f38-c9ec-f6ea-e053-dbdaa90aa703	17f3ea88-b403-4ee3-840a-640a0b9682b7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6031-01	ML - Milliliter	0641-6031	2dae5233-d07b-46db-91cb-9e71b5f65316	1	2013-02-13
0641-6031-10	ML - Milliliter	0641-6031	3864d00e-4977-4367-a919-c0de598aea71	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
FLUMAZENIL	ACTIVE INGREDIENT	40P7XK9392	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
FLUMAZENIL	ACTIVE MOIETY	40P7XK9392	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6031	FLUMAZENIL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1	Legacy NDC	20120611_17f3ea88-b403-4ee3-840a-640a0b9682b7.zip