NDC 70069-441-01 - DICYCLOMINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 70069-441
Requested NDC: 70069-441-01
Package NDCs from labels: 70069-441-01, 70069-441-05
Manufacturer: Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited
Effective date: 2024-11-05
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
DICYCLOMINE - Somerset Therapeutics, LLC \| Somerset Therapeutics Private Limited	Somerset Therapeutics, LLC \| Somerset Therapeutics Private Limited	2024-11-05	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70069-441-01	DICYCLOMINE HYDROCHLORIDE	2 mL in 1 AMPULE	INJECTION, SOLUTION	2		5
70069-441-05	DICYCLOMINE HYDROCHLORIDE	5 in 1 CARTON	INJECTION, SOLUTION	5		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70069-441	DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]	5	Current NDC, 2 package rows	20241106_7ad77f59-e24a-406d-95bf-3d5c6cbc3cbe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70069-441-01	ML - Milliliter	70069-441	6608465f-7c64-4411-9cef-7d5a475da1c3	1	2024-12-10
70069-441-05	ML - Milliliter	70069-441	78e034c3-d360-434c-9d44-e5a333e9a04f	1	2024-12-10

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 55 of 55 · 1,081 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.