Dicyclomine hydrochloride

Product NDC
0143-3126
11-digit product format
001433126
Labeler code
0143
Product ID
0143-3126_008f2526-f7fc-4c9b-939d-04661bcec6be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA040204
Marketing category
ANDA
Marketing start
1997-02-28
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-3126-01EA - Each0143-312669daa5a5-d3c4-47ea-87c6-0921cd9e1cf712013-02-11
0143-3126-10EA - Each0143-3126b22fd2de-3651-408a-beb7-4787a92bc0b312013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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 HYDROCHLORIDE CAPSULE [STAT RX USA]1
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.]1
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [STAT RX USA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [STAT RX USA]1
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE [STAT RX USA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICYCLOMINE CAPSULE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN88942e82-b798-4122-9ea2-0932ef09357f3
991061dicyclomine HCl 10 MG Oral CapsulePSNb9466716-e359-294c-e053-2a95a90af7083
991086dicyclomine HCl 20 MG Oral TabletPSN88942e82-b798-4122-9ea2-0932ef09357f3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD88942e82-b798-4122-9ea2-0932ef09357f3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDb9466716-e359-294c-e053-2a95a90af7083
991086dicyclomine hydrochloride 20 MG Oral TabletSCD88942e82-b798-4122-9ea2-0932ef09357f3
991061dicyclomine HCl 10 MG Oral CapsulePSNc2aac506-3f10-4116-9b65-6341aaaf98931
991061dicyclomine HCl 10 MG Oral CapsulePSNda10031f-9da8-49a2-a019-5ce80c4b7ede1
991061dicyclomine HCl 10 MG Oral CapsulePSNddc61a17-0577-47dc-b323-05e2594a09e61
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDc2aac506-3f10-4116-9b65-6341aaaf98931
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDda10031f-9da8-49a2-a019-5ce80c4b7ede1
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDddc61a17-0577-47dc-b323-05e2594a09e61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-3126-0100143312601100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3126-01) 100 capsule1997-02-280000-00-00NoNoCurrent
0143-3126-10001433126101000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3126-10) 1000 capsule1997-02-280000-00-00NoNoCurrent