FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
70518-1767
11-digit product format
705181767
Labeler code
70518
Product ID
70518-1767_497463c6-3cfc-e95c-e063-6294a90a4389
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040230
Marketing category
ANDA
Marketing start
2019-01-02
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
70518-1767-0Dicyclomine Hydrochloride30 in 1 BLISTER PACKTABLET3012
70518-1767-1Dicyclomine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET18012
70518-1767-2Dicyclomine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET2012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1767-0EA - Each70518-17671681033c-ffc2-4a26-af84-8f7bb2fea4d512025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1767DICYCLOMINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 3 package rows20250228_7ff96d1f-fb87-4244-a697-1d93e10eb738.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN7ff96d1f-fb87-4244-a697-1d93e10eb73812
991086dicyclomine hydrochloride 20 MG Oral TabletSCD7ff96d1f-fb87-4244-a697-1d93e10eb73812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1767-07051817670030 TABLET in 1 BLISTER PACK (70518-1767-0) 30 tablet2019-01-020000-00-00NoNoCurrent
70518-1767-170518176701180 TABLET in 1 BOTTLE, PLASTIC (70518-1767-1) 180 tablet2021-12-080000-00-00NoNoCurrent
70518-1767-27051817670220 TABLET in 1 BOTTLE, PLASTIC (70518-1767-2) 20 tablet2023-08-02NoNoCurrent