Labetalol hydrochloride

Product NDC: 63629-5311
11-digit product format: 636295311
Labeler code: 63629
Product ID: 63629-5311_773b679b-bf61-4391-a79b-3a071c9bfc93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075133
Marketing category: ANDA
Marketing start: 1998-08-03
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: 2021-12-31
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	63629-5311		D	Discontinued by firm	2026-08-17
excluded package	package	63629-5311	63629-5311-1	D	Discontinued by firm	2026-08-17
excluded package	package	63629-5311	63629-5311-2	D	Discontinued by firm	2026-08-17
excluded package	package	63629-5311	63629-5311-3	D	Discontinued by firm	2026-08-17
excluded package	package	63629-5311	63629-5311-4	D	Discontinued by firm	2026-08-17
excluded package	package	63629-5311	63629-5311-5	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 2 · 78 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	63629-5311-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5311-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5311-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5311-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5311-3	`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	63629-5311-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5311-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5311-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5311-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5311-3	`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	63629-5311-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5311-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5311-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5311-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5311-3	`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	63629-5311-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5311-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5311-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5311-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5311-3	`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	63629-5311-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5311-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5311-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5311-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5311-3	`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	63629-5311-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5311-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5311-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5311-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5311-3	`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	63629-5311-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5311-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5311-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5311-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5311-3	`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	63629-5311-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5311-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5311-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5311-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5311-3	`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	63629-5311-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-5311-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-5311-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-5311-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-5311-3	`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	63629-5311-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-5311-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-5311-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-5311-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-5311-3	`ad56d346431e…`	`cc804d4bbf1e…`

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	Approval date
A075133-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03
A075133-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03
A075133-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075133-001	AB
A075133-002	AB
A075133-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`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	A075133-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075133-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075133-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075133-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075133-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075133-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075133-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075133-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075133-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075133-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075133-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075133-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075133-001	AB	1	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-5311-1	2020-10-16	Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only
63629-5311-2	2020-10-16	Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only
63629-5311-3	2020-10-16	Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only
63629-5311-4	2020-10-16	Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only
63629-5311-5	2020-10-16	Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only
63629-5311-1	2020-01-31	Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only
63629-5311-2	2020-01-31	Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only
63629-5311-3	2020-01-31	Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only
63629-5311-4	2020-01-31	Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only
63629-5311-5	2020-01-31	Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LABETALOL HYDROCHLORIDE	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LABETALOL	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
WATER	INACTIVE INGREDIENT	059QF0KO0R	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000

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 · 4 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	a007d945-417c-4647-ab03-95ca219d7d38	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075133 application number: ANDA075133
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	83a6e770-207a-46bc-992d-c1ad90d1006d	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075133 application number: ANDA075133
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	Proficient Rx LP	c0301841-e209-4242-bace-58a20e6dd01b	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075133 application number: ANDA075133
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	Actavis Pharma, Inc.	a5b65a9b-6b8a-48a4-9c72-0e605bb309eb	2015-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075133 application number: ANDA075133

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
63629-5311-1	63629531101	30 TABLET, FILM COATED in 1 BOTTLE (63629-5311-1)	2014-04-16	0000-00-00	No	No	Current
63629-5311-2	63629531102	60 TABLET, FILM COATED in 1 BOTTLE (63629-5311-2)	2014-04-16	0000-00-00	No	No	Current
63629-5311-3	63629531103	58 TABLET, FILM COATED in 1 BOTTLE (63629-5311-3)	2014-04-16	0000-00-00	No	No	Current
63629-5311-4	63629531104	90 TABLET, FILM COATED in 1 BOTTLE (63629-5311-4)	2014-04-16	0000-00-00	No	No	Current
63629-5311-5	63629531105	180 TABLET, FILM COATED in 1 BOTTLE (63629-5311-5)	2014-04-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	1011