FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
24979-200
11-digit product format
249790200
Labeler code
24979
Product ID
24979-200_d1cace55-0a40-4a47-a4d9-d57ed5035686
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA216782
Marketing category
ANDA
Marketing start
2023-07-01
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
24979-200-01Dicyclomine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1007
24979-200-02Dicyclomine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5007
24979-200-03Dicyclomine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-200-01EA - Each24979-2006b27532c-c19c-45fc-9da4-783358c25cc512023-08-08
24979-200-03EA - Each24979-200e352d856-40b4-4e73-9ee4-c1a62611a26712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-200DICYCLOMINE HYDROCHLORIDE TABLET [TWI PHARMACEUTICALS, INC.]5Current NDC, 3 package rows20231202_ceba627b-5fe2-4ab3-b3bc-d90c3a170a93.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
991086dicyclomine HCl 20 MG Oral TabletPSNceba627b-5fe2-4ab3-b3bc-d90c3a170a937
991086dicyclomine hydrochloride 20 MG Oral TabletSCDceba627b-5fe2-4ab3-b3bc-d90c3a170a937
991086dicyclomine HCl 20 MG Oral TabletPSN05552560-6986-f9e8-e063-6394a90a4af04
991086dicyclomine hydrochloride 20 MG Oral TabletSCD05552560-6986-f9e8-e063-6394a90a4af04
991086dicyclomine HCl 20 MG Oral TabletPSN1aebc66d-0636-45ef-8110-7ff49d4dced53
991086dicyclomine hydrochloride 20 MG Oral TabletSCD1aebc66d-0636-45ef-8110-7ff49d4dced53
991086dicyclomine HCl 20 MG Oral TabletPSN1cebadd3-2c45-9cff-e063-6394a90aaceb2
991086dicyclomine hydrochloride 20 MG Oral TabletSCD1cebadd3-2c45-9cff-e063-6394a90aaceb2
991086dicyclomine HCl 20 MG Oral TabletPSN1e0260d0-aaad-aa9f-e063-6294a90a531a1
991086dicyclomine HCl 20 MG Oral TabletPSN2ad04535-1c34-6c5c-e063-6294a90a0c171
991086dicyclomine hydrochloride 20 MG Oral TabletSCD1e0260d0-aaad-aa9f-e063-6294a90a531a1
991086dicyclomine hydrochloride 20 MG Oral TabletSCD2ad04535-1c34-6c5c-e063-6294a90a0c171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24979-200-0124979020001100 TABLET in 1 BOTTLE, PLASTIC (24979-200-01) 100 tablet2023-07-01NoNoHistorical
24979-200-0224979020002500 TABLET in 1 BOTTLE, PLASTIC (24979-200-02) 500 tablet2023-07-01NoNoHistorical
24979-200-03249790200031000 TABLET in 1 BOTTLE, PLASTIC (24979-200-03) 1000 tablet2023-07-01NoNoHistorical