Dicyclomine Hydrochloride

Product NDC
55700-766
11-digit product format
557000766
Labeler code
55700
Product ID
55700-766_601ca4b9-eb4e-47b1-a3ca-1d7554b39489
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA085082
Marketing category
ANDA
Marketing start
2019-06-21
Marketing end
2026-08-31
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991061

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
55700-766-30Dicyclomine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-766-30EA - Each55700-766a74faf7e-60d8-4f33-ac59-e9b49bc90e6312019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-766DICYCLOMINE HYDROCHLORIDE CAPSULE [QUALITY CARE PRODUCTS, LLC]3Current NDC, Legacy NDC, 1 package rows20241220_1d257aa6-9963-4732-93b0-797b06c994ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN1d257aa6-9963-4732-93b0-797b06c994ce3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD1d257aa6-9963-4732-93b0-797b06c994ce3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-766-305570007663030 CAPSULE in 1 BOTTLE, PLASTIC (55700-766-30) 30 capsule2019-06-212026-08-31NoNoCurrent