FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
0832-6052
11-digit product format
008326052
Labeler code
0832
Product ID
0832-6052_43687d93-357b-a540-e063-6394a90a2748
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA216760
Marketing category
ANDA
Marketing start
2022-11-28
Marketing end
2026-09-30
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine hydrochloride

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
0832-6052-10Dicyclomine hydrochloride1000 in 1 BOTTLETABLET10003
0832-6052-11Dicyclomine hydrochloride100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-6052-10EA - Each0832-605264316205-c415-4c86-bd25-8885168aaf6012023-02-06
0832-6052-11EA - Each0832-6052bb3a12af-4c99-44d0-9f35-c196868e953412023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-6052DICYCLOMINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC]2Current NDC, 2 package rows20240713_dda92fd9-d0e2-447b-aae6-012f089a4c2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNdda92fd9-d0e2-447b-aae6-012f089a4c2f3
991086dicyclomine hydrochloride 20 MG Oral TabletSCDdda92fd9-d0e2-447b-aae6-012f089a4c2f3
991086dicyclomine HCl 20 MG Oral TabletPSNf6d02efd-ad65-99e9-e053-6394a90aa5d22
991086dicyclomine hydrochloride 20 MG Oral TabletSCDf6d02efd-ad65-99e9-e053-6394a90aa5d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-6052-10008326052101000 TABLET in 1 BOTTLE (0832-6052-10) 1000 tablet2023-02-092026-06-30NoNoHistorical
0832-6052-1100832605211100 TABLET in 1 BOTTLE (0832-6052-11) 100 tablet2023-02-092026-09-30NoNoHistorical