FDA.reportPublic FDA data

Bethanechol Chloride

Product NDC
65162-573
11-digit product format
651620573
Labeler code
65162
Product ID
65162-573_20630162-d16b-4671-a94a-618acea32787
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bethanechol Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA040855
Marketing category
ANDA
Marketing start
2007-11-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bethanechol Chloride
Listing expiration
2026-12-31

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
65162-573-10Bethanechol Chloride100 in 1 BOTTLETABLET10015
65162-573-11Bethanechol Chloride1000 in 1 BOTTLETABLET100015
65162-573-50Bethanechol Chloride500 in 1 BOTTLETABLET50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-573-10EA - Each65162-57351171924-f4c6-4a6d-a626-50ca344fc14112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETHANECHOL CHLORIDEACTIVE INGREDIENTH4QBZ2LO84BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
BETHANECHOLACTIVE MOIETY004F72P8F4BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
BETHANECHOL CHLORIDEACTIVE INGREDIENTH4QBZ2LO84BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
BETHANECHOLACTIVE MOIETY004F72P8F4BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BETHANECHOL CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-573BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC]15Current NDC, Legacy NDC, 3 package rows20241025_45285692-de51-413e-8a51-7fb792eccc81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857321bethanechol chloride 10 MG Oral TabletPSN45285692-de51-413e-8a51-7fb792eccc8115
857328bethanechol chloride 25 MG Oral TabletPSN45285692-de51-413e-8a51-7fb792eccc8115
857336bethanechol chloride 5 MG Oral TabletPSN45285692-de51-413e-8a51-7fb792eccc8115
857340bethanechol chloride 50 MG Oral TabletPSN45285692-de51-413e-8a51-7fb792eccc8115
857321bethanechol chloride 10 MG Oral TabletSCD45285692-de51-413e-8a51-7fb792eccc8115
857328bethanechol chloride 25 MG Oral TabletSCD45285692-de51-413e-8a51-7fb792eccc8115
857336bethanechol chloride 5 MG Oral TabletSCD45285692-de51-413e-8a51-7fb792eccc8115
857340bethanechol chloride 50 MG Oral TabletSCD45285692-de51-413e-8a51-7fb792eccc8115
857321bethanechol chloride 10 MG Oral TabletPSNb0ed98ac-b41e-49b6-bb7a-8384770fd2142
857328bethanechol chloride 25 MG Oral TabletPSNb0ed98ac-b41e-49b6-bb7a-8384770fd2142
857340bethanechol chloride 50 MG Oral TabletPSNb0ed98ac-b41e-49b6-bb7a-8384770fd2142
857321bethanechol chloride 10 MG Oral TabletSCDb0ed98ac-b41e-49b6-bb7a-8384770fd2142
857328bethanechol chloride 25 MG Oral TabletSCDb0ed98ac-b41e-49b6-bb7a-8384770fd2142
857340bethanechol chloride 50 MG Oral TabletSCDb0ed98ac-b41e-49b6-bb7a-8384770fd2142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-573-1065162057310100 TABLET in 1 BOTTLE (65162-573-10) 100 tablet2007-11-210000-00-00NoNoCurrent
65162-573-11651620573111000 TABLET in 1 BOTTLE (65162-573-11) 1000 tablet2007-11-210000-00-00NoNoCurrent
65162-573-5065162057350500 TABLET in 1 BOTTLE (65162-573-50) 500 tablet2007-11-210000-00-00NoNoCurrent