Bethanechol Chloride

Product NDC
10135-516
11-digit product format
101350516
Labeler code
10135
Product ID
10135-516_399efa61-e065-4cd0-a328-8fde48741122
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bethanechol Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA040704
Marketing category
ANDA
Marketing start
2015-04-01
Marketing end
0000-00-00
Substance
BETHANECHOL CHLORIDE
Active strength
10 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
10135-516-012020-01-31C16284748780-19d75b9d0-7111-f424-e053-dadaa90a57ceBethanechol Chloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-516-01Bethanechol Chloride100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-516-01EA - Each10135-516e400ae66-ebc2-4c70-813b-46aa88dc84e412015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETHANECHOL CHLORIDEACTIVE INGREDIENTH4QBZ2LO84BETHANECHOL CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]1
BETHANECHOLACTIVE MOIETY004F72P8F4BETHANECHOL CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BETHANECHOL CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBETHANECHOL CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBETHANECHOL CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BETHANECHOL CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BETHANECHOL CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]1
SODIUM STARCH GLYCOLATE TYPE B POTATOINACTIVE INGREDIENT27NA468985BETHANECHOL CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBETHANECHOL CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-516BETHANECHOL CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20150604_8d49c7d7-a1ae-423d-98d5-a2fcd5fa3bc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857321bethanechol chloride 10 MG Oral TabletPSN8d49c7d7-a1ae-423d-98d5-a2fcd5fa3bc01
857328bethanechol chloride 25 MG Oral TabletPSN8d49c7d7-a1ae-423d-98d5-a2fcd5fa3bc01
857340bethanechol chloride 50 MG Oral TabletPSN8d49c7d7-a1ae-423d-98d5-a2fcd5fa3bc01
857321bethanechol chloride 10 MG Oral TabletSCD8d49c7d7-a1ae-423d-98d5-a2fcd5fa3bc01
857328bethanechol chloride 25 MG Oral TabletSCD8d49c7d7-a1ae-423d-98d5-a2fcd5fa3bc01
857340bethanechol chloride 50 MG Oral TabletSCD8d49c7d7-a1ae-423d-98d5-a2fcd5fa3bc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-516-0110135051601100 in 1 BOTTLEHistorical