METHSCOPOLAMINE BROMIDE

Product NDC
72319-030
11-digit product format
723190030
Labeler code
72319
Product ID
72319-030_2ee941f2-7d8c-dd6e-e063-6394a90a0db9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methscopolamine bromide
Dosage form
TABLET
Route
ORAL
Labeler
i3 Pharmaceuticals, LLC
Application
ANDA216786
Marketing category
ANDA
Marketing start
2024-12-18
Substance
METHSCOPOLAMINE BROMIDE
Active strength
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 BROMIDE5 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
72319-030-02METHSCOPOLAMINE BROMIDE60 in 1 BOTTLETABLET603
72319-030-06METHSCOPOLAMINE BROMIDE1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72319-030-02EA - Each72319-030c7f061c3-1c52-477b-9129-7c1bb10a725a12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72319-030METHSCOPOLAMINE BROMIDE TABLET [I3 PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20250227_14c0c030-e96d-4a5e-95ff-02dd78a46be3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314088methscopolamine bromide 2.5 MG Oral TabletPSN14c0c030-e96d-4a5e-95ff-02dd78a46be33
403914methscopolamine bromide 5 MG Oral TabletPSN14c0c030-e96d-4a5e-95ff-02dd78a46be33
314088methscopolamine bromide 2.5 MG Oral TabletSCD14c0c030-e96d-4a5e-95ff-02dd78a46be33
403914methscopolamine bromide 5 MG Oral TabletSCD14c0c030-e96d-4a5e-95ff-02dd78a46be33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72319-030-027231900300260 TABLET in 1 BOTTLE (72319-030-02) 60 tablet2024-12-18NoNoHistorical
72319-030-06723190030061000 TABLET in 1 BOTTLE (72319-030-06) 1000 tablet2024-12-18NoNoHistorical