FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
50090-0128
11-digit product format
500900128
Labeler code
50090
Product ID
50090-0128_79b6358e-3913-4cd3-a0b9-decfd7a0f6cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA085082
Marketing category
ANDA
Marketing start
1986-06-19
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
2022-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0128-02023-01-30C16284748780-1f386c64a-48a1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-0128-22023-01-30C16284748780-1f386c64a-48a1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-0128-82023-01-30C16284748780-1f386c64a-48a1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE 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
50090-0128-0Dicyclomine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3028
50090-0128-2Dicyclomine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE6028
50090-0128-8Dicyclomine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0128-0EA - Each50090-01289eab78ef-8013-4767-8b2c-b260a633f52a12018-08-13
50090-0128-2EA - Each50090-0128e626547d-ea5a-403d-835b-9f0da30b6dff12018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0128DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]28Legacy NDC, 3 package rows20210820_8b242ad1-0438-42ed-931b-8f85ea9bc660.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN8b242ad1-0438-42ed-931b-8f85ea9bc66028
991086dicyclomine HCl 20 MG Oral TabletPSN8b242ad1-0438-42ed-931b-8f85ea9bc66028
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD8b242ad1-0438-42ed-931b-8f85ea9bc66028
991086dicyclomine hydrochloride 20 MG Oral TabletSCD8b242ad1-0438-42ed-931b-8f85ea9bc66028

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0128-05009001280030 CAPSULE in 1 BOTTLE, PLASTIC (50090-0128-0) 30 capsule2014-08-240000-00-00NoNoCurrent
50090-0128-25009001280260 CAPSULE in 1 BOTTLE, PLASTIC (50090-0128-2) 60 capsule2014-08-240000-00-00NoNoCurrent
50090-0128-85009001280890 CAPSULE in 1 BOTTLE, PLASTIC (50090-0128-8) 90 capsule2014-08-240000-00-00NoNoCurrent