Methscopolamine Bromide

Product NDC
51991-191
11-digit product format
519910191
Labeler code
51991
Product ID
51991-191_f9a49787-4f81-4993-996c-8b6453b1670c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methscopolamine bromide
Dosage form
TABLET
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA040642
Marketing category
ANDA
Marketing start
2012-05-21
Substance
METHSCOPOLAMINE BROMIDE
Active strength
2.5 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methscopolamine Bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHSCOPOLAMINE BROMIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRTN51LK7WL
Rxcui314088, 403914

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
62bf66cd-09d0-4b08-aa9d-7b67e1476683Product name220250114

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-191-01Methscopolamine Bromide100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-191-01EA - Each51991-19104c4bb95-0189-47be-9429-4527ac9f635112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
methscopolamine bromideACTIVE INGREDIENTRTN51LK7WLMETHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]1
methscopolamineACTIVE MOIETYVDR09VTQ8UMETHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMETHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PMETHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30METHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJMETHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-191METHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]6Current NDC, Legacy NDC, 1 package rows20240327_157c1cce-bceb-4c74-8aa0-d2be9952d8f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314088methscopolamine bromide 2.5 MG Oral TabletPSN157c1cce-bceb-4c74-8aa0-d2be9952d8f96
403914methscopolamine bromide 5 MG Oral TabletPSN157c1cce-bceb-4c74-8aa0-d2be9952d8f96
314088methscopolamine bromide 2.5 MG Oral TabletSCD157c1cce-bceb-4c74-8aa0-d2be9952d8f96
403914methscopolamine bromide 5 MG Oral TabletSCD157c1cce-bceb-4c74-8aa0-d2be9952d8f96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-191-0151991019101100 TABLET in 1 BOTTLE (51991-191-01) 100 tablet2012-05-210000-00-00NoNoCurrent