NDC 36000-320-01 - Labetalol 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: 36000-320
Requested NDC: 36000-320-01
Package NDCs from labels: 36000-320-01, 36000-320-10
Manufacturer: Baxter Healthcare Corporation | CAPLIN STERILES LIMITED
Effective date: 2020-07-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
LABETALOL - Baxter Healthcare Corporation \| CAPLIN STERILES LIMITED	Baxter Healthcare Corporation \| CAPLIN STERILES LIMITED	2020-07-24	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36000-320-01	Labetalol Hydrochloride	4 mL in 1 VIAL	INJECTION, SOLUTION	4		6
36000-320-10	Labetalol Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36000-320	LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	5	Current NDC, Legacy NDC, 2 package rows	20240921_b17a7b3a-e7a5-4987-ae85-ad970e7540c7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36000-320-01	ML - Milliliter	36000-320	b34ef2e5-e1d1-4c87-a0d3-882601c81f1a	1	2021-05-05
36000-320-10	ML - Milliliter	36000-320	6134708c-3a79-4938-bc35-c888ef71af68	1	2021-05-05

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 10 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	794f724c-87f0-49c1-9b26-c9e491978313	2019-11-18		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	5c7d3287-883a-459b-9214-074a583c8a59	2019-11-18		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	448a1dc5-7a98-4b2f-82af-4b92de05cfc3	2019-11-18		Exact identifier unii: XF417D3PSL
Additox	TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	BioActive Nutritional, Inc.	319ee2fe-58e3-495e-bf0d-df201f6fbb1c	2018-07-18	Warnings	Exact identifier unii: Z8IX2SC1OH unii: A2I8C7HI9T
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27		Exact identifier unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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