FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
50090-1577
11-digit product format
500901577
Labeler code
50090
Product ID
50090-1577_56ab32c8-d8a0-45a4-8338-16cf7d1d7d74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040230
Marketing category
ANDA
Marketing start
1999-02-26
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 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
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1577-02023-02-07C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-12023-02-07C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-22023-02-07C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-32023-02-07C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-42023-02-07C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-52023-02-07C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-62023-02-07C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-72023-02-07C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-82023-02-07C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-02023-01-30C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-12023-01-30C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-22023-01-30C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-32023-01-30C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-42023-01-30C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-52023-01-30C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-62023-01-30C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-72023-01-30C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-1577-82023-01-30C16284748780-1f386c64a-0d48-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1577-0Dicyclomine Hydrochloride30 in 1 BOTTLETABLET3024
50090-1577-1Dicyclomine Hydrochloride100 in 1 BOTTLETABLET10024
50090-1577-2Dicyclomine Hydrochloride20 in 1 BOTTLETABLET2024
50090-1577-3Dicyclomine Hydrochloride40 in 1 BOTTLETABLET4024
50090-1577-4Dicyclomine Hydrochloride60 in 1 BOTTLETABLET6024
50090-1577-5Dicyclomine Hydrochloride4 in 1 BOTTLETABLET424
50090-1577-6Dicyclomine Hydrochloride8 in 1 BOTTLETABLET824
50090-1577-7Dicyclomine Hydrochloride10 in 1 BOTTLETABLET1024
50090-1577-8Dicyclomine Hydrochloride90 in 1 BOTTLETABLET9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1577-0EA - Each50090-1577ee75099a-b9cf-44d4-a51b-4016ef7fb2ae12021-09-07
50090-1577-2EA - Each50090-15777e015103-6d4c-4706-ac81-2f19f3a92d2e12021-09-07
50090-1577-8EA - Each50090-15771e764771-af68-4a56-b858-e911aa58231c12021-09-07

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1577DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 9 package rows20240210_b3c9dc85-2c6c-44f0-9c98-02673af934cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNb3c9dc85-2c6c-44f0-9c98-02673af934cb24
991086dicyclomine HCl 20 MG Oral TabletPSNb3c9dc85-2c6c-44f0-9c98-02673af934cb24
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDb3c9dc85-2c6c-44f0-9c98-02673af934cb24
991086dicyclomine hydrochloride 20 MG Oral TabletSCDb3c9dc85-2c6c-44f0-9c98-02673af934cb24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1577-05009015770030 TABLET in 1 BOTTLE (50090-1577-0) 30 tablet2014-12-240000-00-00NoNoCurrent
50090-1577-150090157701100 TABLET in 1 BOTTLE (50090-1577-1) 100 tablet2019-10-090000-00-00NoNoCurrent
50090-1577-25009015770220 TABLET in 1 BOTTLE (50090-1577-2) 20 tablet2014-12-240000-00-00NoNoCurrent
50090-1577-35009015770340 TABLET in 1 BOTTLE (50090-1577-3) 40 tablet2019-10-090000-00-00NoNoCurrent
50090-1577-45009015770460 TABLET in 1 BOTTLE (50090-1577-4) 60 tablet2019-10-090000-00-00NoNoCurrent
50090-1577-5500901577054 TABLET in 1 BOTTLE (50090-1577-5) 4 tablet2019-10-090000-00-00NoNoCurrent
50090-1577-6500901577068 TABLET in 1 BOTTLE (50090-1577-6) 8 tablet2019-10-090000-00-00NoNoCurrent
50090-1577-75009015770710 TABLET in 1 BOTTLE (50090-1577-7) 10 tablet2019-10-090000-00-00NoNoCurrent
50090-1577-85009015770890 TABLET in 1 BOTTLE (50090-1577-8) 90 tablet2014-12-240000-00-00NoNoCurrent