Bethanechol Chloride

Product NDC
0832-0510
11-digit product format
008320510
Labeler code
0832
Product ID
0832-0510_4617beb7-3829-8994-e063-6394a90a14b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bethanechol Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA040633
Marketing category
ANDA
Marketing start
2010-01-24
Substance
BETHANECHOL CHLORIDE
Active strength
5 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 CHLORIDE5 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
0832-0510-00Bethanechol Chloride100 in 1 BOTTLETABLET10013
0832-0510-01Bethanechol Chloride100 in 1 CARTONTABLET10013
0832-0510-10Bethanechol Chloride1000 in 1 BOTTLETABLET100013
0832-0510-89Bethanechol Chloride1 in 1 BLISTER PACKTABLET113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0510-00EA - Each0832-0510168d7c14-aa17-43f1-9a6d-b349a5d4a40c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bethanechol ChlorideACTIVE INGREDIENTH4QBZ2LO84BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]5
BethanecholACTIVE MOIETY004F72P8F4BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UBETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XBETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0510BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC]11Current NDC, Legacy NDC, 4 package rows20240301_80393410-dd51-4cac-b27c-50ece00cca37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857321bethanechol chloride 10 MG Oral TabletPSN80393410-dd51-4cac-b27c-50ece00cca3713
857328bethanechol chloride 25 MG Oral TabletPSN80393410-dd51-4cac-b27c-50ece00cca3713
857336bethanechol chloride 5 MG Oral TabletPSN80393410-dd51-4cac-b27c-50ece00cca3713
857340bethanechol chloride 50 MG Oral TabletPSN80393410-dd51-4cac-b27c-50ece00cca3713
857321bethanechol chloride 10 MG Oral TabletSCD80393410-dd51-4cac-b27c-50ece00cca3713
857328bethanechol chloride 25 MG Oral TabletSCD80393410-dd51-4cac-b27c-50ece00cca3713
857336bethanechol chloride 5 MG Oral TabletSCD80393410-dd51-4cac-b27c-50ece00cca3713
857340bethanechol chloride 50 MG Oral TabletSCD80393410-dd51-4cac-b27c-50ece00cca3713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0510-0000832051000100 TABLET in 1 BOTTLE (0832-0510-00) 100 tablet2010-01-240000-00-00NoNoCurrent
0832-0510-0100832051001100 BLISTER PACK in 1 CARTON (0832-0510-01) / 1 TABLET in 1 BLISTER PACK (0832-0510-89) 100 blister pack2010-01-240000-00-00NoNoCurrent
0832-0510-10008320510101000 TABLET in 1 BOTTLE (0832-0510-10) 1000 tablet2010-01-240000-00-00NoNoCurrent
0832-0510-89008320510891 in 1 BLISTER PACKHistorical