Bethanechol Chloride

Product NDC
55648-965
11-digit product format
556480965
Labeler code
55648
Product ID
55648-965_a3ff540a-0e67-4d4c-ab96-b80b28373771
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bethanechol Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA040532
Marketing category
ANDA
Marketing start
2003-09-29
Marketing end
0000-00-00
Substance
BETHANECHOL CHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-965-012019-11-13C16284748780-197449f38-b591-f6ea-e053-dbdaa90aa703Product Information Bethanechol Chloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-965-01Bethanechol Chloride100 in 1 BOTTLETABLET1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETHANECHOL CHLORIDEACTIVE INGREDIENTH4QBZ2LO84BETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1
BETHANECHOLACTIVE MOIETY004F72P8F4BETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-965BETHANECHOL CHLORIDE TABLET [WOCKHARDT LIMITED]1Legacy NDC, 1 package rows20120207_6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857321bethanechol chloride 10 MG Oral TabletPSN6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e21
857328bethanechol chloride 25 MG Oral TabletPSN6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e21
857336bethanechol chloride 5 MG Oral TabletPSN6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e21
857340bethanechol chloride 50 MG Oral TabletPSN6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e21
857321bethanechol chloride 10 MG Oral TabletSCD6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e21
857328bethanechol chloride 25 MG Oral TabletSCD6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e21
857336bethanechol chloride 5 MG Oral TabletSCD6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e21
857340bethanechol chloride 50 MG Oral TabletSCD6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-965-0155648096501100 in 1 BOTTLEHistorical