FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
71335-2506
11-digit product format
713352506
Labeler code
71335
Product ID
71335-2506_2c521bdf-ff4d-47e3-8776-0ba6e5e6613b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217916
Marketing category
ANDA
Marketing start
2023-09-13
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

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991086

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
71335-2506-0Dicyclomine Hydrochloride10 in 1 BOTTLETABLET102
71335-2506-1Dicyclomine Hydrochloride30 in 1 BOTTLETABLET302
71335-2506-2Dicyclomine Hydrochloride40 in 1 BOTTLETABLET402
71335-2506-3Dicyclomine Hydrochloride60 in 1 BOTTLETABLET602
71335-2506-4Dicyclomine Hydrochloride90 in 1 BOTTLETABLET902
71335-2506-5Dicyclomine Hydrochloride20 in 1 BOTTLETABLET202
71335-2506-6Dicyclomine Hydrochloride21 in 1 BOTTLETABLET212
71335-2506-7Dicyclomine Hydrochloride120 in 1 BOTTLETABLET1202
71335-2506-8Dicyclomine Hydrochloride100 in 1 BOTTLETABLET1002
71335-2506-9Dicyclomine Hydrochloride28 in 1 BOTTLETABLET282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2506-1EA - Each71335-25064b64062d-4101-44a5-9667-d5df765fcaf212025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2506DICYCLOMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2Current NDC, 10 package rows20250212_8561b68a-c88b-4047-9fcf-2df7344543b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN8561b68a-c88b-4047-9fcf-2df7344543b22
991086dicyclomine hydrochloride 20 MG Oral TabletSCD8561b68a-c88b-4047-9fcf-2df7344543b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2506-07133525060010 TABLET in 1 BOTTLE (71335-2506-0) 10 tablet2024-10-07NoNoHistorical
71335-2506-17133525060130 TABLET in 1 BOTTLE (71335-2506-1) 30 tablet2024-10-07NoNoHistorical
71335-2506-27133525060240 TABLET in 1 BOTTLE (71335-2506-2) 40 tablet2024-10-07NoNoHistorical
71335-2506-37133525060360 TABLET in 1 BOTTLE (71335-2506-3) 60 tablet2024-10-07NoNoHistorical
71335-2506-47133525060490 TABLET in 1 BOTTLE (71335-2506-4) 90 tablet2024-10-07NoNoHistorical
71335-2506-57133525060520 TABLET in 1 BOTTLE (71335-2506-5) 20 tablet2024-10-07NoNoHistorical
71335-2506-67133525060621 TABLET in 1 BOTTLE (71335-2506-6) 21 tablet2024-10-07NoNoHistorical
71335-2506-771335250607120 TABLET in 1 BOTTLE (71335-2506-7) 120 tablet2024-10-07NoNoHistorical
71335-2506-871335250608100 TABLET in 1 BOTTLE (71335-2506-8) 100 tablet2024-10-07NoNoHistorical
71335-2506-97133525060928 TABLET in 1 BOTTLE (71335-2506-9) 28 tablet2024-10-07NoNoHistorical