Dicyclomine Hydrochloride

Product NDC
60687-369
11-digit product format
606870369
Labeler code
60687
Product ID
60687-369_20d5c3bc-5e5b-8cfe-e063-6394a90a5618
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA084285
Marketing category
ANDA
Marketing start
2018-10-04
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
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-369-01Dicyclomine Hydrochloride100 in 1 BOX, UNIT-DOSECAPSULE1006
60687-369-11Dicyclomine Hydrochloride1 in 1 BLISTER PACKCAPSULE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-369-01EA - Each60687-3694ca30f53-a9a5-4958-b935-265c01abafe412018-11-06
60687-369-11EA - Each60687-369b1d09f1c-c6b0-459b-a36d-1a429784281212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-369DICYCLOMINE 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 CapsulePSN63b207da-159c-4cb5-8b06-616ed4811c126
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 CapsuleSCD63b207da-159c-4cb5-8b06-616ed4811c126
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
60687-369-0160687036901100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-369-01) / 1 CAPSULE in 1 BLISTER PACK (60687-369-11) 100 blister pack2018-10-040000-00-00NoNoCurrent
60687-369-11606870369111 in 1 BLISTER PACKHistorical