Labetalol hydrochloride

Product NDC: 21695-592
11-digit product format: 216950592
Labeler code: 21695
Product ID: 21695-592_7cdbf66c-9548-47ac-b79a-10a9934c1a29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA075133
Marketing category: ANDA
Marketing start: 1998-08-03
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: E
Listing certified through: 2017-12-31
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	21695-592		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-592	21695-592-30	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-592	21695-592-60	I	Inactivated by FDA	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 · 66 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	21695-592-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-592-30	`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	21695-592-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-592-30	`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	21695-592-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-592-30	`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	21695-592-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-592-30	`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	21695-592-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-592-30	`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	21695-592-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-592-30	`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	21695-592-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-592-30	`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	21695-592-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-592-30	`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	21695-592-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-592-30	`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	21695-592-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-592-30	`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	21695-592-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-592-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-592-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-592-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-592-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-592-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-592-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-592-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-592-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-592-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-592-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-592-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-592-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-592-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-592-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-592-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-592-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-592-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-592-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-592-30	`e2bbac7714bc…`	`27bdfed8d636…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-592-30	2019-09-24	C162847	48780-1	934fe258-48e7-48b1-e053-8cdaa90a720a	Labetalol Hydrochloride Tablets USP Revised : July 2008 Rx only 2000623
21695-592-60	2019-09-24	C162847	48780-1	934fe258-48e7-48b1-e053-8cdaa90a720a	Labetalol Hydrochloride Tablets USP Revised : July 2008 Rx only 2000623

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-592-30	Labetalol hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		2
21695-592-60	Labetalol hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-592-30	EA - Each	21695-592	1f8008f6-f84e-40ad-8a1c-5768afcfebef	1	2012-07-24
21695-592-60	EA - Each	21695-592	15e49ae2-60b2-4b88-b7c9-ad3da606aa17	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
LABETALOL HYDROCHLORIDE	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
LABETALOL	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-592	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 2 package rows	20111220_d555e256-c8ba-414e-8bba-4e1222356d14.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896758	labetalol HCl 100 MG Oral Tablet	PSN	d555e256-c8ba-414e-8bba-4e1222356d14	2
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	d555e256-c8ba-414e-8bba-4e1222356d14	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-592-30	21695059230	30 in 1 BOTTLE, PLASTIC	Historical
21695-592-60	21695059260	60 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets USP Revised : July 2008 Rx only 2000623	Rebel Distributors Corp	2010-12-28	HUMAN PRESCRIPTION DRUG LABEL	2