NDC 70594-111-01 - Acetylcysteine

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: 70594-111
Requested NDC: 70594-111-01
Package NDCs from labels: 70594-111-01, 70594-111-02
Manufacturer: Xellia Pharmaceuticals USA LLC
Effective date: 2023-05-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Acetylcysteine - Xellia Pharmaceuticals USA LLC	Xellia Pharmaceuticals USA LLC	2023-05-31	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70594-111-01	Acetylcysteine	30 mL in 1 VIAL	INJECTION, SOLUTION	30		2
70594-111-02	Acetylcysteine	4 in 1 CARTON	INJECTION, SOLUTION	4		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70594-111	ACETYLCYSTEINE INJECTION, SOLUTION [XELLIA PHARMACEUTICALS USA LLC]	2	Current NDC, 2 package rows	20230621_3e2e187e-2445-43b1-b66c-b828e2adf022.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70594-111-01	ML - Milliliter	70594-111	71c23865-11aa-494a-afb3-2b4a225ddab9	1	2023-09-05
70594-111-02	ML - Milliliter	70594-111	aa5adcd2-ba0b-4aa9-8771-45e3ad0aa502	1	2023-09-05

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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetylcysteine	ACETYLCYSTEINE	Sagent Pharmaceuticals	2324d60b-4f49-4759-a46e-a06bfce7e8aa	2022-04-05	Warnings, Adverse reactions	Exact identifier rxcui: 465377 unii: WYQ7N0BPYC
ACETYLCYSTEINE	ACETYLCYSTEINE	Indoco Remedies Limited	6588c28d-0515-4cdf-99d3-c4ad3fd0976c	2022-03-01	Warnings, Adverse reactions	Exact identifier rxcui: 465377 unii: WYQ7N0BPYC

Reported adverse events (FAERS/openFDA)#

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