NDC 14445-412-30 - 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: 14445-412
Requested NDC: 14445-412-30
Package NDCs from labels: 14445-412-30, 14445-412-04
Manufacturer: Indoco Remedies Limited
Effective date: 2022-03-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ACETYLCYSTEINE - Indoco Remedies Limited	Indoco Remedies Limited	2022-03-01	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
14445-412-04	ACETYLCYSTEINE	4 in 1 CARTON	INJECTION	4		4
14445-412-30	ACETYLCYSTEINE	30 mL in 1 VIAL	INJECTION	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14445-412	ACETYLCYSTEINE INJECTION [INDOCO REMEDIES LIMITED ]	4	Current NDC, Legacy NDC, 2 package rows	20220302_6588c28d-0515-4cdf-99d3-c4ad3fd0976c.zip

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 9 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetylcysteine	ACETYLCYSTEINE	Fresenius Kabi USA, LLC	d990ef51-ced2-4359-b99b-092334d2dc9b	2022-10-31	Warnings, Adverse reactions	Exact identifier rxcui: 465377 unii: WYQ7N0BPYC
Acetylcysteine	ACETYLCYSTEINE	Fresenius Kabi USA, LLC	8d81039e-20ef-5144-e053-2a95a90a89fd	2022-10-31	Warnings, Adverse reactions	Exact identifier unii: WYQ7N0BPYC
Sterile Water	WATER	Fresenius Kabi USA, LLC	b45e9f1d-9c48-4b46-8541-d846b89540df	2022-10-26	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye wash	PURIFIED WATER	McKesson	bd089fde-24ba-4de5-e053-2995a90a39bb	2022-10-18	Warnings	Exact identifier unii: 059QF0KO0R
Bach Original Flower Remedies Rock Water	WATER	Nelson Bach USA Limited	ea242559-1618-3354-e053-2a95a90a1a95	2022-10-03	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Acetylcysteine	ACETYLCYSTEINE	Sagent Pharmaceuticals	2324d60b-4f49-4759-a46e-a06bfce7e8aa	2022-04-05	Warnings, Adverse reactions	Exact identifier rxcui: 465377 unii: WYQ7N0BPYC
Miracle FootCream Lavender	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db520c80-2a2a-5eb1-e053-2995a90a5bb4	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
Miracle FootCream Lemon	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db525c63-29fd-2033-e053-2995a90a56b9	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
ACETYLCYSTEINE	ACETYLCYSTEINE	Indoco Remedies Limited	6588c28d-0515-4cdf-99d3-c4ad3fd0976c	2022-03-01	Warnings, Adverse reactions	Exact identifier application number: ANDA215620 ndc (package): 14445-412-30 ndc (package): 14445-412-04 ndc (product): 14445-412 ndc11 (package): 14445041230 rxcui: 465377 spl id: 2b8da336-9b90-466e-9ac2-6f6cbb999f9f spl set id: 6588c28d-0515-4cdf-99d3-c4ad3fd0976c unii: WYQ7N0BPYC
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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