FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
71205-428
11-digit product format
712050428
Labeler code
71205
Product ID
71205-428_254cd89b-86ad-4846-a5d3-5fe66e0d1e81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA085082
Marketing category
ANDA
Marketing start
1986-06-19
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
71205-428-15Dicyclomine Hydrochloride15 in 1 BOTTLE, PLASTICCAPSULE152
71205-428-20Dicyclomine Hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE202
71205-428-30Dicyclomine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE302
71205-428-60Dicyclomine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE602
71205-428-90Dicyclomine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-428-15EA - Each71205-42893073f97-f406-4d1e-861f-248f56b9db5412020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-428DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 5 package rows20230712_346bbb6a-3499-4e90-af22-95f1cd0c0417.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN346bbb6a-3499-4e90-af22-95f1cd0c04172
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD346bbb6a-3499-4e90-af22-95f1cd0c04172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-428-157120504281515 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-15) 15 capsule2020-03-120000-00-00NoNoCurrent
71205-428-207120504282020 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-20) 20 capsule2020-03-120000-00-00NoNoCurrent
71205-428-307120504283030 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-30) 30 capsule2020-03-120000-00-00NoNoCurrent
71205-428-607120504286060 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-60) 60 capsule2020-03-120000-00-00NoNoCurrent
71205-428-907120504289090 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-90) 90 capsule2020-03-120000-00-00NoNoCurrent