FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
71335-0425
11-digit product format
713350425
Labeler code
71335
Product ID
71335-0425_8bde11c1-3380-437d-beda-1eb263058208
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040230
Marketing category
ANDA
Marketing start
1999-02-26
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
71335-0425-1Dicyclomine Hydrochloride30 in 1 BOTTLETABLET3010
71335-0425-2Dicyclomine Hydrochloride40 in 1 BOTTLETABLET4010
71335-0425-3Dicyclomine Hydrochloride60 in 1 BOTTLETABLET6010
71335-0425-4Dicyclomine Hydrochloride90 in 1 BOTTLETABLET9010
71335-0425-5Dicyclomine Hydrochloride20 in 1 BOTTLETABLET2010
71335-0425-6Dicyclomine Hydrochloride21 in 1 BOTTLETABLET2110
71335-0425-7Dicyclomine Hydrochloride120 in 1 BOTTLETABLET12010
71335-0425-8Dicyclomine Hydrochloride100 in 1 BOTTLETABLET10010
71335-0425-9Dicyclomine Hydrochloride28 in 1 BOTTLETABLET2810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0425-1EA - Each71335-04256e6bc18a-194e-4dab-b14e-40ffbbf028a612018-03-08
71335-0425-2EA - Each71335-0425fec8e589-6229-4e59-9237-fd80268ab1d512018-03-08
71335-0425-3EA - Each71335-0425a239c964-e4cc-48e4-94c7-fcf1d2b0f77e12018-03-08
71335-0425-4EA - Each71335-0425630bd52a-c02c-4a5a-9709-09de7072d32012018-03-08
71335-0425-5EA - Each71335-0425fa5b3465-8208-43f3-8cbc-ce4b5888410412018-03-08
71335-0425-6EA - Each71335-04253c7c6df1-ae12-47f5-937e-94f039c2b67312018-03-08
71335-0425-7EA - Each71335-04250217747d-3b23-4652-be69-c654e4f11ae912018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0425DICYCLOMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 9 package rows20240828_34db5a80-f445-41e5-b3c4-4c18abb09c92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN34db5a80-f445-41e5-b3c4-4c18abb09c9210
991086dicyclomine hydrochloride 20 MG Oral TabletSCD34db5a80-f445-41e5-b3c4-4c18abb09c9210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0425-17133504250130 TABLET in 1 BOTTLE (71335-0425-1) 30 tablet2018-02-220000-00-00NoNoCurrent
71335-0425-27133504250240 TABLET in 1 BOTTLE (71335-0425-2) 40 tablet2021-12-270000-00-00NoNoCurrent
71335-0425-37133504250360 TABLET in 1 BOTTLE (71335-0425-3) 60 tablet2020-11-120000-00-00NoNoCurrent
71335-0425-47133504250490 TABLET in 1 BOTTLE (71335-0425-4) 90 tablet2020-03-260000-00-00NoNoCurrent
71335-0425-57133504250520 TABLET in 1 BOTTLE (71335-0425-5) 20 tablet2018-05-040000-00-00NoNoCurrent
71335-0425-67133504250621 TABLET in 1 BOTTLE (71335-0425-6) 21 tablet2021-12-270000-00-00NoNoCurrent
71335-0425-771335042507120 TABLET in 1 BOTTLE (71335-0425-7) 120 tablet2021-12-270000-00-00NoNoCurrent
71335-0425-871335042508100 TABLET in 1 BOTTLE (71335-0425-8) 100 tablet2021-12-270000-00-00NoNoCurrent
71335-0425-97133504250928 TABLET in 1 BOTTLE (71335-0425-9) 28 tablet2020-06-010000-00-00NoNoCurrent