DICYCLOMINE HYDROCHLORIDE

Product NDC
73473-800
11-digit product format
734730800
Labeler code
73473
Product ID
73473-800_8aedf1df-44c6-47d1-8a9d-8ce2b757ae12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICYCLOMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Solaris Pharma Corporation
Application
ANDA216639
Marketing category
ANDA
Marketing start
2025-06-10
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

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
73473-800-01DICYCLOMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1003
73473-800-10DICYCLOMINE HYDROCHLORIDE1000 in 1 BOTTLECAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73473-800-01EA - Each73473-8008d0e75f9-affb-4a26-8746-e08300a47f4b12025-08-11
73473-800-10EA - Each73473-800dbe19e18-c250-4371-a139-1c1466a6f6b012025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN4237bb2e-d6dd-4e3a-baa2-85be5dc3c8f23
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD4237bb2e-d6dd-4e3a-baa2-85be5dc3c8f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73473-800-0173473080001100 CAPSULE in 1 BOTTLE (73473-800-01) 100 capsule2025-06-10NoNoHistorical
73473-800-10734730800101000 CAPSULE in 1 BOTTLE (73473-800-10) 1000 capsule2025-06-10NoNoHistorical