NDC 53489-356 - 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: 53489-356
Package NDCs from labels: 53489-356-07, 53489-356-06, 53489-356-01, 53489-356-03, 53489-356-05, 53489-356-10
Manufacturer: Mutual Pharmaceutical Company, Inc.
Effective date: 2007-01-03
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
LABETALOL HYDROCHLORIDE TABLETS, USP	Mutual Pharmaceutical Company, Inc.	2007-01-03	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53489-356-01	Labetalol Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	1
53489-356-03	Labetalol Hydrochloride	250 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	250	1
53489-356-05	Labetalol Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	1
53489-356-06	Labetalol Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	1
53489-356-07	Labetalol Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	1
53489-356-10	Labetalol Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53489-356	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1	6 package rows	20070111_B1E6C7AB-EEFE-4089-B403-EDEAAB4F6E36.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Labetalol Hydrochloride	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
Labetalol	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
Anhydrous lactose	INACTIVE INGREDIENT		LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
carnauba wax	INACTIVE INGREDIENT		LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
FD&C Blue #2 aluminum lake	INACTIVE INGREDIENT		LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
hydroxypropyl methylcellulose	INACTIVE INGREDIENT		LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
polydextrose	INACTIVE INGREDIENT		LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
polyethylene glycol	INACTIVE INGREDIENT		LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
polysorbate 80	INACTIVE INGREDIENT		LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
pregelatinized starch (corn)	INACTIVE INGREDIENT		LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
synthetic red iron oxide	INACTIVE INGREDIENT		LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
synthetic yellow iron oxide	INACTIVE INGREDIENT		LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]	1

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 4 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	c586ab65-56e8-4a4f-b471-902198d3e58c	2023-10-17	Warnings, Adverse reactions	Exact identifier rxcui: 896758
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Cadila Pharmaceuticals Limited	5fba93fc-4580-48c2-a1ec-5d446680adcf	2022-12-09	Warnings, Adverse reactions	Exact identifier rxcui: 896766 rxcui: 896758 rxcui: 896762
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	Proficient Rx LP	c0301841-e209-4242-bace-58a20e6dd01b	2022-11-01	Warnings, Adverse reactions	Exact identifier rxcui: 896758
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Epic Pharma, LLC	b950655d-a9f8-4ace-bb56-0c7abbca231e	2021-09-30	Warnings, Adverse reactions	Exact identifier rxcui: 896766 rxcui: 896758 rxcui: 896762
B1E6C7AB-EEFE-4089-B403-EDEAAB4F6E36			B1E6C7AB-EEFE-4089-B403-EDEAAB4F6E36	2007-01-03	Warnings, Adverse reactions	Exact identifier spl id: B1E6C7AB-EEFE-4089-B403-EDEAAB4F6E36 spl set id: B1E6C7AB-EEFE-4089-B403-EDEAAB4F6E36

Reported adverse events (FAERS/openFDA)#

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