Dicyclomine Hydrochloride

Product NDC
24979-201
11-digit product format
249790201
Labeler code
24979
Product ID
24979-201_db3661e3-f00b-4eb0-8674-4bf781e66cf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA217054
Marketing category
ANDA
Marketing start
2023-02-01
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
24979-201-01Dicyclomine Hydrochloride100 in 1 BOTTLECAPSULE1008
24979-201-03Dicyclomine Hydrochloride1000 in 1 BOTTLECAPSULE10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-201-01EA - Each24979-201fab20ae8-836e-4efa-8c5c-b1d02c64434912023-05-05
24979-201-03EA - Each24979-20131da4d5d-990f-4a80-a38b-6cd08dbe538012023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-201DICYCLOMINE HYDROCHLORIDE CAPSULE [UPSHER-SMITH LABORATORIES, LLC]6Current NDC, 2 package rows20250212_66cf2cc1-6011-4879-8b25-8701b0677ac6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN4ae8d2fd-a7fb-4cc4-a2cb-720c5a2e2022101
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD4ae8d2fd-a7fb-4cc4-a2cb-720c5a2e2022101
991061dicyclomine HCl 10 MG Oral CapsulePSN66cf2cc1-6011-4879-8b25-8701b0677ac68
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD66cf2cc1-6011-4879-8b25-8701b0677ac68
991061dicyclomine HCl 10 MG Oral CapsulePSN141d3818-7a87-aaa0-e063-6294a90a48663
991061dicyclomine HCl 10 MG Oral CapsulePSN4f6f4402-865b-44fb-9bfe-4e224d57e6dc3
991061dicyclomine HCl 10 MG Oral CapsulePSN59422db6-b22d-447a-9393-46347406b3383
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD141d3818-7a87-aaa0-e063-6294a90a48663
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD4f6f4402-865b-44fb-9bfe-4e224d57e6dc3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD59422db6-b22d-447a-9393-46347406b3383
991061dicyclomine HCl 10 MG Oral CapsulePSN07f0b3aa-a649-0f6c-e063-6294a90a152c2
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD07f0b3aa-a649-0f6c-e063-6294a90a152c2
991061dicyclomine HCl 10 MG Oral CapsulePSN8652905b-b3f1-4eed-bde8-ce507186ae9a1
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD8652905b-b3f1-4eed-bde8-ce507186ae9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24979-201-0124979020101100 CAPSULE in 1 BOTTLE (24979-201-01) 100 capsule2023-02-01NoNoHistorical
24979-201-03249790201031000 CAPSULE in 1 BOTTLE (24979-201-03) 1000 capsule2023-02-01NoNoHistorical