BENZTROPINE MESYLATE

Product NDC
70518-2677
11-digit product format
705182677
Labeler code
70518
Product ID
70518-2677_4dc40b79-328a-5fcd-e063-6394a90a619d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090168
Marketing category
ANDA
Marketing start
2020-04-08
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

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 Identifiers#

Field, Values table
FieldValues
UniiWMJ8TL7510
Rxcui885209

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
70518-2677-0BENZTROPINE MESYLATE30 in 1 BLISTER PACKTABLET3014
70518-2677-1BENZTROPINE MESYLATE30 in 1 BLISTER PACKTABLET3014
70518-2677-2BENZTROPINE MESYLATE100 in 1 BOXTABLET10014
70518-2677-3BENZTROPINE MESYLATE1 in 1 POUCHTABLET114
70518-2677-4BENZTROPINE MESYLATE100 in 1 BOXTABLET10014
70518-2677-5BENZTROPINE MESYLATE1 in 1 POUCHTABLET114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2677-0EA - Each70518-267719f41b3a-b4b6-4b72-91a4-cdb67a4492d012026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2677BENZTROPINE MESYLATE TABLET [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 6 package rows20250327_7430b584-2812-4af5-994a-33dd1afed476.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885209benztropine mesylate 2 MG Oral TabletPSN7430b584-2812-4af5-994a-33dd1afed47614
885209benztropine mesylate 2 MG Oral TabletSCD7430b584-2812-4af5-994a-33dd1afed47614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2677-07051826770030 TABLET in 1 BLISTER PACK (70518-2677-0) 30 tablet2020-04-080000-00-00NoNoCurrent
70518-2677-17051826770130 TABLET in 1 BLISTER PACK (70518-2677-1) 30 tablet2020-10-050000-00-00NoNoCurrent
70518-2677-270518267702100 POUCH in 1 BOX (70518-2677-2) / 1 TABLET in 1 POUCH (70518-2677-3) 100 pouch2026-02-11NoNoHistorical
70518-2677-3705182677031 in 1 POUCHHistorical
70518-2677-470518267704100 POUCH in 1 BOX (70518-2677-4) / 1 TABLET in 1 POUCH (70518-2677-5) 100 pouch2026-03-24NoNoHistorical
70518-2677-5705182677051 in 1 POUCHHistorical