FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
70436-147
11-digit product format
704360147
Labeler code
70436
Product ID
70436-147_4c2eae9b-279f-0604-e063-6394a90aaf35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA207076
Marketing category
ANDA
Marketing start
2021-09-23
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/2mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991065

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70436-147-812026-01-29C16284748780-149896155-b029-586f-e063-e6dba90add90These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE INJECTION. DICYCLOMINE HYDROCHLORIDE injection, USP for intramuscular use Initial U.S. Approval: 1950
70436-147-812026-01-29C16284748780-149896155-b029-586f-e063-e6dba90add90These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE INJECTION. DICYCLOMINE HYDROCHLORIDE injection, USP for intramuscular use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-147-80Dicyclomine Hydrochloride2 mL in 1 VIALINJECTION210
70436-147-81Dicyclomine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION210
70436-147-81Dicyclomine Hydrochloride5 in 1 BOXINJECTION510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-147-80ML - Milliliter70436-1477e7e54c1-9617-488b-aab3-554b9a0a06e112026-03-17
70436-147-81ML - Milliliter70436-14703d7c1da-952b-49b5-9ed3-0cb3f05934be12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-147DICYCLOMINE HYDROCHLORIDE INJECTION [SLATE RUN PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 3 package rows20241226_e20a1ccf-2f3a-4872-811e-d93fb56b8e83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991065dicyclomine HCl 20 MG in 2 ML InjectionPSNe20a1ccf-2f3a-4872-811e-d93fb56b8e8310
9910652 ML dicyclomine hydrochloride 10 MG/ML InjectionSCDe20a1ccf-2f3a-4872-811e-d93fb56b8e8310
991065dicyclomine hydrochloride 20 MG per 2 ML InjectionSYe20a1ccf-2f3a-4872-811e-d93fb56b8e8310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70436-147-80704360147802 mL in 1 VIAL (70436-147-80) 2 ml2021-09-23NoNoHistorical
70436-147-81704360147815 VIAL, SINGLE-DOSE in 1 BOX (70436-147-81) / 2 mL in 1 VIAL, SINGLE-DOSE2021-09-230000-00-00NoNoCurrent