FDA.reportPublic FDA data

BENZTROPINE MESYLATE

Product NDC
72162-2596
Requested package NDC
72162-2596-2
11-digit product format
721622596
Labeler code
72162
Product ID
72162-2596_959a0659-677c-4d0d-a77d-bf41abd0cebc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212694
Marketing category
ANDA
Marketing start
2025-08-11
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212694-001BENZTROPINE MESYLATEBENZTROPINE MESYLATE0.5MGTABLET / ORALAA2025-02-11
A212694-002BENZTROPINE MESYLATEBENZTROPINE MESYLATE1MGTABLET / ORALAA2025-02-11
A212694-003BENZTROPINE MESYLATEBENZTROPINE MESYLATE2MGTABLET / ORALAA2025-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212694-001AA
A212694-002AA
A212694-003AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212694-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2025-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A212694-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2025-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A212694-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2025-02-1184e616aacf4f…
2026-08-18 06:07:402026-07A212694-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2025-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A212694-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2025-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A212694-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2025-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212694-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2025-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212694-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2025-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212694-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2025-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212694-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2025-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212694-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2025-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212694-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2025-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212694-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2025-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212694-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2025-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212694-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2025-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212694-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2025-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212694-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2025-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212694-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2025-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212694-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2025-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212694-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2025-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212694-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2025-02-11b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212694-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2025-02-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212694-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2025-02-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212694-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2025-02-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212694-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A212694-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A212694-003AA184e616aacf4f…
2026-08-18 06:07:402026-07A212694-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A212694-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A212694-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212694-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212694-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212694-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212694-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212694-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212694-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212694-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212694-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212694-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212694-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212694-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212694-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212694-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212694-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212694-003AA1b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212694-001AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212694-002AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212694-003AA1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
BENZTROPINE MESYLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZTROPINE MESYLATE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WMJ8TL7510Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
885209Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
284e78af-7544-4c4a-8081-74e45501dc76Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2961cf47-535c-c402-c24d-0a9130269674Product name320251121
3f930a8b-cc65-fba9-e4ca-58b6abcea16bProduct name220220509

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2596-0BENZTROPINE MESYLATE1000 in 1 BOTTLETABLET1000100
72162-2596-1BENZTROPINE MESYLATE100 in 1 BOTTLETABLET100100
72162-2596-2BENZTROPINE MESYLATE100 in 1 BOTTLETABLET100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2596-0EA - Each72162-2596eb40daa9-9716-4c53-8152-5d9506a599cc12026-02-05
72162-2596-1EA - Each72162-25969c16dce1-ada9-42c9-90e2-3a9f3ea0c04d12026-02-05
72162-2596-2EA - Each72162-2596f5fc34a6-6a8f-47d0-b966-030edb53019e12026-02-05

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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepackae749a71-d253-474d-a26c-bec780c5b09c2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212694
application number: ANDA212694
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack9270d14c-b885-4679-8871-6f25474503982026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212694
application number: ANDA212694
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack284e78af-7544-4c4a-8081-74e45501dc762026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212694
application number: ANDA212694
ndc (package): 72162-2596-2
ndc (product): 72162-2596
ndc11 (package): 72162259602
BENZTROPINE MESYLATEBENZTROPINE MESYLATEQUAGEN PHARMACEUTICALS LLCe1f0a249-e660-4592-9ffc-1c02b10227782025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212694
application number: ANDA212694

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885209benztropine mesylate 2 MG Oral TabletPSN284e78af-7544-4c4a-8081-74e45501dc76100
885209benztropine mesylate 2 MG Oral TabletSCD284e78af-7544-4c4a-8081-74e45501dc76100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2596-272162259602100 TABLET in 1 BOTTLE (72162-2596-2) 100 tablet2026-01-07NoNoCurrent