Dicyclomine Hydrochloride

Product NDC
71335-2341
11-digit product format
713352341
Labeler code
71335
Product ID
71335-2341_8821239c-0d7f-4b89-90ba-554ca3e3d66a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040317
Marketing category
ANDA
Marketing start
2023-04-25
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
CQ903KQA31DICYCLOMINE HYDROCHLORIDE67-92-5DICYCLOMINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2341-17133523410130 TABLET in 1 BOTTLE (71335-2341-1) 30 tablet2024-02-06NoNoHistorical
71335-2341-27133523410240 TABLET in 1 BOTTLE (71335-2341-2) 40 tablet2024-02-06NoNoHistorical
71335-2341-37133523410360 TABLET in 1 BOTTLE (71335-2341-3) 60 tablet2024-02-06NoNoHistorical
71335-2341-47133523410490 TABLET in 1 BOTTLE (71335-2341-4) 90 tablet2024-02-06NoNoHistorical
71335-2341-57133523410520 TABLET in 1 BOTTLE (71335-2341-5) 20 tablet2024-02-06NoNoHistorical
71335-2341-67133523410621 TABLET in 1 BOTTLE (71335-2341-6) 21 tablet2024-02-06NoNoHistorical
71335-2341-771335234107120 TABLET in 1 BOTTLE (71335-2341-7) 120 tablet2024-02-06NoNoHistorical
71335-2341-871335234108100 TABLET in 1 BOTTLE (71335-2341-8) 100 tablet2024-02-06NoNoHistorical
71335-2341-97133523410928 TABLET in 1 BOTTLE (71335-2341-9) 28 tablet2024-02-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dicyclomine HydrochlorideBryant Ranch Prepack2024-02-06HUMAN PRESCRIPTION DRUG LABEL100