FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
50268-199
11-digit product format
502680199
Labeler code
50268
Product ID
50268-199_47e343c9-2e61-c288-e063-6394a90a0b5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA217054
Marketing category
ANDA
Marketing start
2024-03-20
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2027-12-31

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
50268-199-11Dicyclomine Hydrochloride1 in 1 BLISTER PACKCAPSULE13
50268-199-15Dicyclomine Hydrochloride50 in 1 BOXCAPSULE503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-199-11EA - Each50268-1998eb780a6-907e-4b33-8550-4cb994b2feda12024-04-05
50268-199-15EA - Each50268-199eb8f0d59-2033-4a36-8aef-f2016d7a835412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-199DICYCLOMINE HYDROCHLORIDE CAPSULE [AVPAK]2Current NDC, 2 package rows20240615_141d3818-7a87-aaa0-e063-6294a90a4866.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN141d3818-7a87-aaa0-e063-6294a90a48663
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD141d3818-7a87-aaa0-e063-6294a90a48663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-199-11502680199111 in 1 BLISTER PACKHistorical
50268-199-155026801991550 BLISTER PACK in 1 BOX (50268-199-15) / 1 CAPSULE in 1 BLISTER PACK (50268-199-11) 50 blister pack2024-03-20NoNoHistorical