Benztropine Mesylate

Product NDC: 0603-2439
Requested package NDC: 0603-2439-32
11-digit product format: 006032439
Labeler code: 0603
Product ID: 0603-2439_7d977221-80bc-44cc-8210-c69e9bd3e368
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benztropine mesylate
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA204713
Marketing category: ANDA
Marketing start: 2017-05-15
Marketing end: 0000-00-00
Substance: BENZTROPINE MESYLATE
Active strength: 2 mg/1
Pharmacologic classes: Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0603-2439	0603-2439-32	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204713-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14
A204713-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14
A204713-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204713-001	AA
A204713-002	AA
A204713-003	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A204713-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204713-002	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204713-003	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Marlex PHARMACEUTICAL, INC	31bbcbfa-dc74-99e2-e063-6394a90aa608	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204713 application number: ANDA204713
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	SUNRISE PHARMACEUTICAL, INC	2c988462-ce77-4e99-b98e-8f6ad519e295	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204713 application number: ANDA204713

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-2439-21	EA - Each	0603-2439	8c1750b6-8907-4e62-9c25-8811fa0c8763	1	2017-08-11
0603-2439-32	EA - Each	0603-2439	67fd8676-d5fa-4a40-9936-29a3d10d8704	1	2017-08-11

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WMJ8TL7510	BENZTROPINE MESYLATE	132-17-2	BENZTROPINE MESYLATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-2439-32	00603243932	1000 TABLET in 1 BOTTLE, PLASTIC (0603-2439-32)	1000 tablet	2017-05-15	2024-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZTROPINE MESYLATE TABLETS USP	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
BENZTROPINE MESYLATE TABLETS USP	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
BENZTROPINE MESYLATE TABLETS USP	REMEDYREPACK INC.	2024-01-05	HUMAN PRESCRIPTION DRUG LABEL	12
BENZTROPINE MESYLATE TABLETS USP	NCS HealthCare of KY, LLC dba Vangard Labs	2023-05-02	HUMAN PRESCRIPTION DRUG LABEL	11
Benztropine Mesylate Tablets, USP 8435601/0322 Rx only	American Health Packaging	2023-03-13	HUMAN PRESCRIPTION DRUG LABEL	6
BENZTROPINE MESYLATE TABLETS USP	Major Pharmaceuticals	2021-12-03	HUMAN PRESCRIPTION DRUG LABEL	3
BENZTROPINE MESYLATE TABLETS USP	Par Pharmaceutical, Inc. \| Aspen Global Inc. \| Sunrise Pharmaceutical Inc.	2021-01-07	HUMAN PRESCRIPTION DRUG LABEL	9
BENZTROPINE MESYLATE TABLETS USP	A-S Medication Solutions	2018-10-10	HUMAN PRESCRIPTION DRUG LABEL	3