Bethanechol Chloride

Product NDC
53746-573
11-digit product format
537460573
Labeler code
53746
Product ID
53746-573_18da1d47-681c-49d7-a3ce-487dc57405f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bethanechol Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040855
Marketing category
ANDA
Marketing start
2022-04-15
Substance
BETHANECHOL CHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bethanechol Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETHANECHOL CHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH4QBZ2LO84
Rxcui857321, 857328, 857336, 857340

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92b44811-8b40-083f-6ae6-fb73b958b054Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-573-01Bethanechol Chloride100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-573-01EA - Each53746-573e2c901d6-26c5-4f6f-8c98-6084045cd68e12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-573BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]4Current NDC, Legacy NDC, 1 package rows20240118_16523451-cd3d-4c10-be06-d59a6f12ac68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857321bethanechol chloride 10 MG Oral TabletPSN16523451-cd3d-4c10-be06-d59a6f12ac685
857328bethanechol chloride 25 MG Oral TabletPSN16523451-cd3d-4c10-be06-d59a6f12ac685
857336bethanechol chloride 5 MG Oral TabletPSN16523451-cd3d-4c10-be06-d59a6f12ac685
857340bethanechol chloride 50 MG Oral TabletPSN16523451-cd3d-4c10-be06-d59a6f12ac685
857321bethanechol chloride 10 MG Oral TabletSCD16523451-cd3d-4c10-be06-d59a6f12ac685
857328bethanechol chloride 25 MG Oral TabletSCD16523451-cd3d-4c10-be06-d59a6f12ac685
857336bethanechol chloride 5 MG Oral TabletSCD16523451-cd3d-4c10-be06-d59a6f12ac685
857340bethanechol chloride 50 MG Oral TabletSCD16523451-cd3d-4c10-be06-d59a6f12ac685
857321bethanechol chloride 10 MG Oral TabletPSNda12a817-9f34-4f26-a7dc-e0e8f9be91c32
857328bethanechol chloride 25 MG Oral TabletPSNda12a817-9f34-4f26-a7dc-e0e8f9be91c32
857321bethanechol chloride 10 MG Oral TabletSCDda12a817-9f34-4f26-a7dc-e0e8f9be91c32
857328bethanechol chloride 25 MG Oral TabletSCDda12a817-9f34-4f26-a7dc-e0e8f9be91c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-573-0153746057301100 TABLET in 1 BOTTLE (53746-573-01) 100 tablet2022-04-150000-00-00NoNoCurrent