NDC 0517-0785-01 - Benztropine Mesylate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0517-0785
Requested NDC: 0517-0785-01
Package NDCs from labels: 0517-0785-01, 0517-0785-05
Manufacturer: American Regent, Inc.
Effective date: 2011-05-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Benztropine Mesylate Injection, USP	American Regent, Inc.	2011-05-10	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0517-0785-05	2019-12-04	C162847	48780-1	960f7f55-d8ad-8e05-e053-dbdaa90a074a	Benztropine Mesylate Injection, USP
0517-0785-05	2019-10-29	C162847	48780-1	960f7f55-d8ad-8e05-e053-dbdaa90a074a	Benztropine Mesylate Injection, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-0785-05	ML - Milliliter	0517-0785	3378fb4c-9f3a-42a7-b1b0-ef6803f53553	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	1
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 50 of 50 · 983 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21	Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.