Benztropine Mesylate

Product NDC
70518-0132
11-digit product format
705180132
Labeler code
70518
Product ID
70518-0132_4b190ae7-cfb1-c5df-e063-6294a90ac4e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040742
Marketing category
ANDA
Marketing start
2017-01-17
Substance
BENZTROPINE MESYLATE
Active strength
1 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 MESYLATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWMJ8TL7510
Rxcui885213

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
70518-0132-0Benztropine Mesylate30 in 1 BLISTER PACKTABLET3014
70518-0132-1Benztropine Mesylate30 in 1 BLISTER PACKTABLET3014
70518-0132-2Benztropine Mesylate100 in 1 BOXTABLET10014
70518-0132-3Benztropine Mesylate1 in 1 POUCHTABLET114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0132BENZTROPINE MESYLATE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 4 package rows20250529_09e3e099-0b29-4ab5-bf35-5e41355dd454.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885213benztropine mesylate 1 MG Oral TabletPSN09e3e099-0b29-4ab5-bf35-5e41355dd45414
885213benztropine mesylate 1 MG Oral TabletSCD09e3e099-0b29-4ab5-bf35-5e41355dd45414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-0132-07051801320030 in 1 BLISTER PACKHistorical
70518-0132-17051801320130 TABLET in 1 BLISTER PACK (70518-0132-1) 30 tablet2023-06-08NoNoCurrent
70518-0132-270518013202100 POUCH in 1 BOX (70518-0132-2) / 1 TABLET in 1 POUCH (70518-0132-3) 100 pouch2026-01-05NoNoCurrent
70518-0132-3705180132031 in 1 POUCHHistorical