Labetalol HCL

Product NDC: 63629-9185
11-digit product format: 636299185
Labeler code: 63629
Product ID: 63629-9185_b32a345f-c892-494c-be87-8c2a2b17a3f6
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: 300 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-9185		D	Discontinued by firm	2026-09-14
excluded package	package	63629-9185	63629-9185-1	D	Discontinued by firm	2026-09-14
excluded package	package	63629-9185	63629-9185-2	D	Discontinued by firm	2026-09-14

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 · 33 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-9185-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-9185-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-9185-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-9185-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-9185-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-9185-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-9185-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-9185-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-9185-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-9185-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-9185-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-9185-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-9185-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-9185-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-9185-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-9185-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-9185-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-9185-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-9185-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-9185-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-9185-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-9185-1	`367a005e9d99…`	`383a685ebd0f…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-9185-1	EA - Each	63629-9185	59ed293f-08e9-4371-88fe-50f4d27b1014	1	2022-09-12
63629-9185-2	EA - Each	63629-9185	5f612101-b32e-4e77-ad24-dcf65748250c	1	2022-09-12

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-9185-1	63629918501	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9185-1)	2022-08-03	0000-00-00	No	No	Current
63629-9185-2	63629918502	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9185-2)	2022-08-03	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	2024-01-12	HUMAN PRESCRIPTION DRUG LABEL	102