Labetalol Hydrochloride

Product NDC: 55154-2339
Requested package NDC: 55154-2339-0
11-digit product format: 551542339
Labeler code: 55154
Product ID: 55154-2339_9c79527a-b5aa-4f81-9bfc-b557286ce1cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health
Application: ANDA207743
Marketing category: ANDA
Marketing start: 2017-12-05
Marketing end: 0000-00-00
Substance: LABETALOL HYDROCHLORIDE
Active strength: 200 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55154-2339	55154-2339-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	RLD / RS	Approval date
A207743-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19
A207743-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2017-09-19
A207743-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207743-001	AB
A207743-002	AB
A207743-003	AB

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 · 126 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
2026-08-18 06:07:40	2026-07	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207743-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207743-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207743-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207743-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207743-001	AB	1	`1e350fbaab3a…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	BluePoint Laboratories Inc.	63ede355-42ec-4c52-a941-51e5f6b35ed6	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	9c3bb751-c425-43ff-b530-2460b568b689	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Cardinal Health 107, LLC	63db5b00-e864-4b2d-84f2-00bf35211b9b	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	American Health Packaging	3004aa59-288c-4971-b77b-78789715ef5a	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Lifesciences Limited	a3c0cc1e-1c01-4009-afdc-d35a66546aec	2024-11-30		Exact identifier application applno (ANDA): 207743 application number: ANDA207743

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-2339-0	55154233900	10 BLISTER PACK in 1 BAG (55154-2339-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2017-12-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets, USP Rx only	Cardinal Health 107, LLC	2024-09-17	HUMAN PRESCRIPTION DRUG LABEL	5