FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
43547-634
11-digit product format
435470634
Labeler code
43547
Product ID
43547-634_d0954a7a-812b-487e-8c22-2a2a58303277
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Solco Healthcare US,LLC
Application
ANDA217531
Marketing category
ANDA
Marketing start
2022-08-23
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
43547-634-10Dicyclomine hydrochloride100 in 1 BOTTLECAPSULE1001
43547-634-11Dicyclomine hydrochloride1000 in 1 BOTTLECAPSULE10001
43547-634-50Dicyclomine hydrochloride500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-634-10EA - Each43547-63407f67633-d49b-4b83-a7e4-b6a606dc670512024-01-04
43547-634-11EA - Each43547-634eb06c4c0-6089-4ff6-af6c-ede99cae77e312024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-634DICYCLOMINE HYDROCHLORIDE CAPSULE [SOLCO HEALTHCARE US,LLC]1Current NDC, 3 package rows20230831_d0954a7a-812b-487e-8c22-2a2a58303277.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN3745661f-5d24-487d-e063-6294a90a5a683
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD3745661f-5d24-487d-e063-6294a90a5a683
991061dicyclomine HCl 10 MG Oral CapsulePSN2d439669-5cbc-292f-e063-6394a90a7ca91
991061dicyclomine HCl 10 MG Oral CapsulePSNd0954a7a-812b-487e-8c22-2a2a583032771
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD2d439669-5cbc-292f-e063-6394a90a7ca91
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDd0954a7a-812b-487e-8c22-2a2a583032771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43547-634-1043547063410100 CAPSULE in 1 BOTTLE (43547-634-10) 100 capsule2022-08-23NoNoHistorical
43547-634-11435470634111000 CAPSULE in 1 BOTTLE (43547-634-11) 1000 capsule2022-08-23NoNoHistorical
43547-634-5043547063450500 CAPSULE in 1 BOTTLE (43547-634-50) 500 capsule2022-08-23NoNoHistorical