Dicyclomine hydrochloride

Product NDC
71335-2226
11-digit product format
713352226
Labeler code
71335
Product ID
71335-2226_f2ba56dd-bb4e-4d75-ba92-2e3899a313b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216736
Marketing category
ANDA
Marketing start
2022-12-14
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
71335-2226-07133522260010 TABLET in 1 BOTTLE (71335-2226-0) 10 tablet2023-08-23NoNoHistorical
71335-2226-17133522260130 TABLET in 1 BOTTLE (71335-2226-1) 30 tablet2023-08-23NoNoHistorical
71335-2226-27133522260240 TABLET in 1 BOTTLE (71335-2226-2) 40 tablet2023-08-23NoNoHistorical
71335-2226-37133522260360 TABLET in 1 BOTTLE (71335-2226-3) 60 tablet2023-08-23NoNoHistorical
71335-2226-47133522260490 TABLET in 1 BOTTLE (71335-2226-4) 90 tablet2023-08-23NoNoHistorical
71335-2226-57133522260520 TABLET in 1 BOTTLE (71335-2226-5) 20 tablet2023-08-23NoNoHistorical
71335-2226-67133522260621 TABLET in 1 BOTTLE (71335-2226-6) 21 tablet2023-08-23NoNoHistorical
71335-2226-771335222607120 TABLET in 1 BOTTLE (71335-2226-7) 120 tablet2023-08-23NoNoHistorical
71335-2226-871335222608100 TABLET in 1 BOTTLE (71335-2226-8) 100 tablet2023-08-23NoNoHistorical
71335-2226-97133522260928 TABLET in 1 BOTTLE (71335-2226-9) 28 tablet2023-08-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dicyclomine hydrochlorideBryant Ranch Prepack2025-10-22HUMAN PRESCRIPTION DRUG LABEL101
Dicyclomine hydrochlorideBryant Ranch Prepack2023-08-23HUMAN PRESCRIPTION DRUG LABEL100