FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
70518-3917
11-digit product format
705183917
Labeler code
70518
Product ID
70518-3917_4aa0eee6-1269-e6ee-e063-6294a90a4db1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA216782
Marketing category
ANDA
Marketing start
2023-11-19
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3917-0Dicyclomine Hydrochloride30 in 1 BLISTER PACKTABLET308
70518-3917-1Dicyclomine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1808
70518-3917-2Dicyclomine Hydrochloride30 in 1 BLISTER PACKTABLET308
70518-3917-3Dicyclomine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET208
70518-3917-4Dicyclomine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1808

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3917DICYCLOMINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]4Current NDC, 5 package rows20240720_2c36b79f-153c-446c-899b-6e28ccff1dc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN2c36b79f-153c-446c-899b-6e28ccff1dc88
991086dicyclomine hydrochloride 20 MG Oral TabletSCD2c36b79f-153c-446c-899b-6e28ccff1dc88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3917-07051839170030 TABLET in 1 BLISTER PACK (70518-3917-0) 30 tablet2023-11-19NoNoHistorical
70518-3917-170518391701180 TABLET in 1 BOTTLE, PLASTIC (70518-3917-1) 180 tablet2024-04-16NoNoHistorical
70518-3917-27051839170230 TABLET in 1 BLISTER PACK (70518-3917-2) 30 tablet2024-07-19NoNoHistorical
70518-3917-37051839170320 TABLET in 1 BOTTLE, PLASTIC (70518-3917-3) 20 tablet2025-10-09NoNoHistorical
70518-3917-470518391704180 TABLET in 1 BOTTLE, PLASTIC (70518-3917-4) 180 tablet2026-02-11NoNoHistorical