Labetalol HCL

Product NDC: 71335-2145
11-digit product format: 713352145
Labeler code: 71335
Product ID: 71335-2145_efc3fa1f-504f-4b85-b736-294a6e8fda50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA200908
Marketing category: ANDA
Marketing start: 2012-07-24
Marketing end: 0000-00-00
Substance: LABETALOL HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-2145		D	Discontinued by firm	2026-09-14
excluded package	package	71335-2145	71335-2145-1	D	Discontinued by firm	2026-09-14
excluded package	package	71335-2145	71335-2145-2	D	Discontinued by firm	2026-09-14
excluded package	package	71335-2145	71335-2145-3	D	Discontinued by firm	2026-09-14
excluded package	package	71335-2145	71335-2145-4	D	Discontinued by firm	2026-09-14
excluded package	package	71335-2145	71335-2145-5	D	Discontinued by firm	2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A200908-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2012-07-10
A200908-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2012-07-10
A200908-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2012-07-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL			2012-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL			2012-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL			2012-07-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL			2012-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL			2012-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL			2012-07-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200908-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2012-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200908-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2012-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200908-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2012-07-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200908-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200908-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200908-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200908-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200908-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200908-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200908-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200908-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200908-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200908-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200908-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200908-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200908-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200908-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200908-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200908-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200908-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200908-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200908-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200908-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200908-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200908-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200908-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200908-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200908-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200908-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200908-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200908-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200908-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200908-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200908-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200908-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200908-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200908-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200908-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200908-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200908-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200908-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200908-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200908-001	AB	1	`8072bd15b7f6…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77f	Product name	2	20220311
759f1c41-9262-4238-8cee-33988631aaf4	Product name	5	20220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21	Product name	1	20210527
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2145-1	Labetalol HCL	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	102
71335-2145-2	Labetalol HCL	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	102
71335-2145-3	Labetalol HCL	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	102
71335-2145-4	Labetalol HCL	120 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	120	102
71335-2145-5	Labetalol HCL	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2145	LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	102	Legacy NDC, 5 package rows	20241019_f1f28e7a-048c-436b-8901-7072ac1d81b7.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol HCL	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	312dde0d-5147-483e-968f-4e0d46114176	2025-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200908 application number: ANDA200908

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1GEV3BAW9J	LABETALOL HYDROCHLORIDE	32780-64-6	LABETALOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896758	labetalol HCl 100 MG Oral Tablet	PSN	f1f28e7a-048c-436b-8901-7072ac1d81b7	102
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	f1f28e7a-048c-436b-8901-7072ac1d81b7	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-2145-1	71335214501	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2145-1)	2022-08-09	0000-00-00	No	No	Current
71335-2145-2	71335214502	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2145-2)	2022-08-09	0000-00-00	No	No	Current
71335-2145-3	71335214503	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2145-3)	2022-08-09	0000-00-00	No	No	Current
71335-2145-4	71335214504	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2145-4)	2022-08-09	0000-00-00	No	No	Current
71335-2145-5	71335214505	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2145-5)	2022-08-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only	Bryant Ranch Prepack	2024-10-04	HUMAN PRESCRIPTION DRUG LABEL	102