Dicyclomine Hydrochloride

Product NDC: 68071-2868
11-digit product format: 680712868
Labeler code: 68071
Product ID: 68071-2868_ec94d19c-33da-dc02-e053-2995a90a01be
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA040230
Marketing category: ANDA
Marketing start: 1999-02-26
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f755a917-03bc-45af-a1e3-50286868bfdb	Product name	9	20250303
f27796e1-d653-495b-932a-f51768e9be8a	Product name	2	20211021

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2868-6	2025-01-30	C162847	48780-1	2cef2736-5b44-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2868-6	Dicyclomine Hydrochloride	6 in 1 BOTTLE	TABLET	6		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2868	DICYCLOMINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20221104_ec94d19c-33d9-dc02-e053-2995a90a01be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	ec94d19c-33d9-dc02-e053-2995a90a01be	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	ec94d19c-33d9-dc02-e053-2995a90a01be	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2868-6	68071286806	6 TABLET in 1 BOTTLE (68071-2868-6)	6 tablet	2022-11-03	0000-00-00	No	No	Current