FDA.reportPublic FDA data

DICYCLOMINE HYDROCHLORIDE

Product NDC
61919-324
11-digit product format
619190324
Labeler code
61919
Product ID
61919-324_f2126a96-6338-7052-e053-2a95a90af277
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICYCLOMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA085223
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
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
61919-324-302025-01-30C16284748780-12cef2736-83e9-d83d-e063-dadaa90ab31fDICYCLOMINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-324-30DICYCLOMINE HYDROCHLORIDE30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-324-30EA - Each61919-324c17a6664-594f-4403-8920-fa741d4f2ce212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-324DICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]5Legacy NDC, 1 package rows20230420_ebaf5799-80f9-4e16-9e11-99eaf30531f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNebaf5799-80f9-4e16-9e11-99eaf30531f45
991086dicyclomine hydrochloride 20 MG Oral TabletSCDebaf5799-80f9-4e16-9e11-99eaf30531f45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-324-306191903243030 TABLET in 1 BOTTLE (61919-324-30) 30 tablet2015-01-010000-00-00NoNoCurrent