FDA.reportPublic FDA data

Dicyclomine

Product NDC
0143-1227
11-digit product format
001431227
Labeler code
0143
Product ID
0143-1227_ab1abd30-25fd-46ed-a992-925836112c98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA040161
Marketing category
ANDA
Marketing start
1996-10-01
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine
Listing expiration
2026-12-31

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
0143-1227-01Dicyclomine100 in 1 BOTTLE, PLASTICTABLET10013
0143-1227-10Dicyclomine1000 in 1 BOTTLE, PLASTICTABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1227-01EA - Each0143-12271c21019a-5837-42d8-8434-9b7b0a433afa12012-07-24
0143-1227-10EA - Each0143-122726b43e46-348b-40c2-830c-b996e13cbd1b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [WEST-WARD PHARMACEUTICAL CORP]7
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDICYCLOMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]1
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STAT RX USA LLC]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STAT RX USA LLC]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STAT RX USA LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-1227DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 2 package rows20221202_5a553bda-1e3d-4b80-913f-73dd54655033.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN5a553bda-1e3d-4b80-913f-73dd5465503313
991086dicyclomine hydrochloride 20 MG Oral TabletSCD5a553bda-1e3d-4b80-913f-73dd5465503313
991086dicyclomine HCl 20 MG Oral TabletPSNa330a08e-0cb6-bc66-e053-2995a90ad9e98
991086dicyclomine hydrochloride 20 MG Oral TabletSCDa330a08e-0cb6-bc66-e053-2995a90ad9e98
991086dicyclomine HCl 20 MG Oral TabletPSNb1db8bc1-2fcc-45c3-b49a-c8968649d5e76
991086dicyclomine hydrochloride 20 MG Oral TabletSCDb1db8bc1-2fcc-45c3-b49a-c8968649d5e76
991086dicyclomine HCl 20 MG Oral TabletPSN8b7af7c1-72ce-4d29-947f-aa6dd24f078b4
991086dicyclomine hydrochloride 20 MG Oral TabletSCD8b7af7c1-72ce-4d29-947f-aa6dd24f078b4
991061dicyclomine HCl 10 MG Oral CapsulePSN88942e82-b798-4122-9ea2-0932ef09357f3
991086dicyclomine HCl 20 MG Oral TabletPSN88942e82-b798-4122-9ea2-0932ef09357f3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD88942e82-b798-4122-9ea2-0932ef09357f3
991086dicyclomine hydrochloride 20 MG Oral TabletSCD88942e82-b798-4122-9ea2-0932ef09357f3
991086dicyclomine HCl 20 MG Oral TabletPSN2c656550-7e5b-445f-e063-6294a90a8f522
991086dicyclomine hydrochloride 20 MG Oral TabletSCD2c656550-7e5b-445f-e063-6294a90a8f522
991086dicyclomine HCl 20 MG Oral TabletPSN59b1b2cc-73ce-49cf-a87a-05a2d6428be51
991086dicyclomine HCl 20 MG Oral TabletPSNaa8350bd-f832-4983-baed-2a6978819b491
991086dicyclomine HCl 20 MG Oral TabletPSNd70e3238-cb91-44eb-8598-f8713b89be971
991086dicyclomine hydrochloride 20 MG Oral TabletSCDaa8350bd-f832-4983-baed-2a6978819b491
991086dicyclomine hydrochloride 20 MG Oral TabletSCD59b1b2cc-73ce-49cf-a87a-05a2d6428be51
991086dicyclomine hydrochloride 20 MG Oral TabletSCDd70e3238-cb91-44eb-8598-f8713b89be971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-1227-0100143122701100 TABLET in 1 BOTTLE, PLASTIC (0143-1227-01) 100 tablet1996-10-010000-00-00NoNoCurrent
0143-1227-10001431227101000 TABLET in 1 BOTTLE, PLASTIC (0143-1227-10) 1000 tablet1996-10-010000-00-00NoNoCurrent