Dicyclomine Hydrochloride

Product NDC
63187-196
11-digit product format
631870196
Labeler code
63187
Product ID
63187-196_33e2fa6e-66b0-436e-8a4d-235f3ba2c94d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA084285
Marketing category
ANDA
Marketing start
1974-09-30
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991061, 991086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-196-30Dicyclomine Hydrochloride30 in 1 BOTTLECAPSULE307
63187-196-90Dicyclomine Hydrochloride90 in 1 BOTTLECAPSULE907

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
ACACIAINACTIVE INGREDIENT5C5403N26ODICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71ODICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-196DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]6Current NDC, Legacy NDC, 2 package rows20240907_3b7145d7-1ba7-45c1-8202-b8fc575d5a8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN3b7145d7-1ba7-45c1-8202-b8fc575d5a8e7
991086dicyclomine HCl 20 MG Oral TabletPSN3b7145d7-1ba7-45c1-8202-b8fc575d5a8e7
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD3b7145d7-1ba7-45c1-8202-b8fc575d5a8e7
991086dicyclomine hydrochloride 20 MG Oral TabletSCD3b7145d7-1ba7-45c1-8202-b8fc575d5a8e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-196-306318701963030 CAPSULE in 1 BOTTLE (63187-196-30) 30 capsule2015-08-030000-00-00NoNoCurrent
63187-196-606318701966060 CAPSULE in 1 BOTTLE (63187-196-60) 60 capsule2015-08-030000-00-00NoNoCurrent
63187-196-906318701969090 CAPSULE in 1 BOTTLE (63187-196-90) 90 capsule2015-08-030000-00-00NoNoCurrent