DICYCLOMINE HYDROCHLORIDE

Product NDC
73473-902
11-digit product format
734730902
Labeler code
73473
Product ID
73473-902_98b3a053-2708-460d-9929-d89164cd4a49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICYCLOMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Solaris Pharma Corporation
Application
ANDA216760
Marketing category
ANDA
Marketing start
2025-06-10
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
Rxcui991086

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
73473-902-01DICYCLOMINE HYDROCHLORIDE100 in 1 BOTTLETABLET1001
73473-902-10DICYCLOMINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73473-902-01EA - Each73473-902f0cd152a-362b-4640-b3bb-8f9d20435df412025-08-11
73473-902-10EA - Each73473-902f04e2f65-97a2-4d62-8138-d9939d2c002b12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNd46259e6-5eca-4356-bc18-815104c925cc1
991086dicyclomine hydrochloride 20 MG Oral TabletSCDd46259e6-5eca-4356-bc18-815104c925cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73473-902-0173473090201100 TABLET in 1 BOTTLE (73473-902-01) 100 tablet2025-06-10NoNoHistorical
73473-902-10734730902101000 TABLET in 1 BOTTLE (73473-902-10) 1000 tablet2025-06-10NoNoHistorical