METHSCOPOLAMINE BROMIDE

Product NDC
76385-100
11-digit product format
763850100
Labeler code
76385
Product ID
76385-100_10a9a368-4ddc-4ffc-abfb-605c98fe1d97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methscopolamine bromide
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA200602
Marketing category
ANDA
Marketing start
2013-10-01
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
76385-100-01METHSCOPOLAMINE BROMIDE100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-100-01EA - Each76385-1000e4a0351-9434-4be0-ba1f-de613d848b3d12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHSCOPOLAMINE BROMIDEACTIVE INGREDIENTRTN51LK7WLMETHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]2
METHSCOPOLAMINEACTIVE MOIETYVDR09VTQ8UMETHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-100METHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 1 package rows20200127_5c74bfb0-c80a-4a86-acd1-1e3a1b20255d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314088methscopolamine bromide 2.5 MG Oral TabletPSN4ee28ed4-daff-462c-a38b-4fd8250ed9f4101
314088methscopolamine bromide 2.5 MG Oral TabletSCD4ee28ed4-daff-462c-a38b-4fd8250ed9f4101
314088methscopolamine bromide 2.5 MG Oral TabletPSN26cd56db-4727-40d1-8f08-3ee899052c7711
314088methscopolamine bromide 2.5 MG Oral TabletSCD26cd56db-4727-40d1-8f08-3ee899052c7711
314088methscopolamine bromide 2.5 MG Oral TabletPSN5c74bfb0-c80a-4a86-acd1-1e3a1b20255d9
403914methscopolamine bromide 5 MG Oral TabletPSN5c74bfb0-c80a-4a86-acd1-1e3a1b20255d9
314088methscopolamine bromide 2.5 MG Oral TabletSCD5c74bfb0-c80a-4a86-acd1-1e3a1b20255d9
403914methscopolamine bromide 5 MG Oral TabletSCD5c74bfb0-c80a-4a86-acd1-1e3a1b20255d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76385-100-0176385010001100 TABLET in 1 BOTTLE (76385-100-01) 100 tablet2013-10-010000-00-00NoNoCurrent