Dicyclomine Hydrochloride

Product NDC
60687-380
11-digit product format
606870380
Labeler code
60687
Product ID
60687-380_20d5c3bc-5e5b-8cfe-e063-6394a90a5618
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040230
Marketing category
ANDA
Marketing start
2018-12-06
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-380-01Dicyclomine Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1006
60687-380-11Dicyclomine Hydrochloride1 in 1 BLISTER PACKTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-380-01EA - Each60687-380d3740645-9ed8-4f4c-ba40-9083c05cfae512018-11-06
60687-380-11EA - Each60687-380f0edf5d7-873e-4c32-bb4c-d2d2d86adbd512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-380DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20240830_833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe86
991086dicyclomine HCl 20 MG Oral TabletPSN833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe86
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe86
991086dicyclomine hydrochloride 20 MG Oral TabletSCD833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-380-0160687038001100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-380-01) / 1 TABLET in 1 BLISTER PACK (60687-380-11) 100 blister pack2018-12-060000-00-00NoNoCurrent
60687-380-11606870380111 in 1 BLISTER PACKHistorical