Dicyclomine hydrochloride

Product NDC
73352-119
11-digit product format
733520119
Labeler code
73352
Product ID
73352-119_4008fdd6-a9b7-b299-e063-6394a90afdfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Trifluent Pharma, LLC
Application
ANDA216736
Marketing category
ANDA
Marketing start
2025-07-14
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui2719470

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
73352-119-60Dicyclomine hydrochloride60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-119-60EA - Each73352-119ef4d1713-d0aa-4cb7-b08c-573bbad1849e12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719470dicyclomine hydrochloride 40 MG Oral TabletPSN56282794-5874-4220-b25c-cea4b17d19aa2
2719470dicyclomine hydrochloride 40 MG Oral TabletSCD56282794-5874-4220-b25c-cea4b17d19aa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73352-119-607335201196060 TABLET in 1 BOTTLE (73352-119-60) 60 tablet2025-07-14NoNoHistorical