Labetalol Hydrochloride

Product NDC: 50090-4149
11-digit product format: 500904149
Labeler code: 50090
Product ID: 50090-4149_7164c86a-8886-404a-924f-af4b75dc28e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: labetalol hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA018716
Marketing category: NDA
Marketing start: 2018-03-01
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: 2022-12-31
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	50090-4149		I	Inactivated by FDA	2026-10-05
excluded package	package	50090-4149	50090-4149-0	I	Inactivated by FDA	2026-10-05
excluded package	package	50090-4149	50090-4149-1	I	Inactivated by FDA	2026-10-05

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 · 45 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	50090-4149-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4149-1	`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	50090-4149-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4149-1	`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	50090-4149-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4149-1	`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	50090-4149-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4149-1	`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	50090-4149-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4149-1	`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	50090-4149-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4149-1	`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	50090-4149-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4149-1	`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	50090-4149-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4149-1	`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	50090-4149-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4149-1	`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	50090-4149-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-4149-1	`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	50090-4149-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-4149-1	`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	50090-4149-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-4149-1	`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	50090-4149-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4149-1	`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	50090-4149-0	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4149-1	`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	50090-4149-0	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4149-1	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018716-001	TRANDATE	LABETALOL HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24
N018716-002	TRANDATE	LABETALOL HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01
N018716-003	TRANDATE	LABETALOL HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01
N018716-004	TRANDATE	LABETALOL HYDROCHLORIDE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018716-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018716-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018716-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018716-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018716-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018716-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018716-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018716-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018716-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018716-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018716-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018716-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018716-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018716-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018716-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018716-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018716-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018716-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018716-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018716-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018716-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018716-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018716-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018716-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018716-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018716-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018716-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018716-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018716-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018716-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018716-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018716-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018716-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018716-003	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018716-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018716-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018716-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018716-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018716-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018716-003	AB	1	`a67488948f0b…`

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
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
50090-4149-0	2023-01-30	C162847	48780-1	f386c649-d300-0266-e053-dadaa90a7c1a	Labetalol Hydrochloride Tablets
50090-4149-1	2023-01-30	C162847	48780-1	f386c649-d300-0266-e053-dadaa90a7c1a	Labetalol Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4149-0	Labetalol Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60		4
50090-4149-1	Labetalol Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4149-0	EA - Each	50090-4149	9050d60b-6ea7-4af9-8726-fc8f761181da	1	2022-01-06
50090-4149-1	EA - Each	50090-4149	d5beb324-eb5a-47a9-8e7d-69d243609fc2	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4149	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 2 package rows	20210303_23b3a6a8-b53e-46a1-ad2f-8a33e1c22fcf.zip

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	23b3a6a8-b53e-46a1-ad2f-8a33e1c22fcf	4
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	23b3a6a8-b53e-46a1-ad2f-8a33e1c22fcf	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4149-0	50090414900	60 TABLET, FILM COATED in 1 BOTTLE (50090-4149-0)	2019-02-20	0000-00-00	No	No	Current
50090-4149-1	50090414901	90 TABLET, FILM COATED in 1 BOTTLE (50090-4149-1)	2019-02-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	4