Labetalol Hydrochloride

Product NDC: 68258-6047
11-digit product format: 682586047
Labeler code: 68258
Product ID: 68258-6047_85ac20d9-9737-449c-9929-e84c649f5a00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA074787
Marketing category: ANDA
Marketing start: 2011-01-01
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: 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	68258-6047		I	Inactivated by FDA	2026-08-17
excluded package	package	68258-6047	68258-6047-3	I	Inactivated by FDA	2026-08-17
excluded package	package	68258-6047	68258-6047-9	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	68258-6047-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-6047-3	`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	68258-6047-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-6047-3	`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	68258-6047-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-6047-3	`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	68258-6047-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-6047-3	`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	68258-6047-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-6047-3	`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	68258-6047-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-6047-3	`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	68258-6047-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-6047-3	`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	68258-6047-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-6047-3	`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	68258-6047-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-6047-3	`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	68258-6047-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-6047-3	`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	68258-6047-9	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68258-6047-3	`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	68258-6047-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68258-6047-3	`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	68258-6047-9	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-6047-3	`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	68258-6047-9	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-6047-3	`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	68258-6047-9	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-6047-3	`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	68258-6047-9	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-6047-3	`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	68258-6047-9	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-6047-3	`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	68258-6047-9	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-6047-3	`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	68258-6047-9	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-6047-3	`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	68258-6047-9	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-6047-3	`e2bbac7714bc…`	`27bdfed8d636…`

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

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	TE codes	Approval date
A074787-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03
A074787-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03
A074787-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03
A074787-004	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2026-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074787-001	AB
A074787-002	AB
A074787-003	AB
A074787-004	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 · 128 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	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074787-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2026-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 121 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	A074787-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074787-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074787-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074787-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074787-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074787-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074787-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074787-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074787-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074787-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074787-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074787-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074787-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074787-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074787-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074787-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074787-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074787-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074787-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074787-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074787-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074787-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074787-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074787-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074787-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074787-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074787-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074787-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074787-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074787-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074787-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074787-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074787-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074787-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074787-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074787-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074787-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074787-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074787-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074787-003	AB	1	`301d65b070ca…`

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
68258-6047-3	2019-11-27	C162847	48780-1	9855e2a2-5031-60a7-e053-dbdaa90a05bd	LABETALOL HYDROCHLORIDE TABLETS USP Rx only
68258-6047-9	2019-11-27	C162847	48780-1	9855e2a2-5031-60a7-e053-dbdaa90a05bd	LABETALOL HYDROCHLORIDE TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-6047-3	Labetalol Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		2
68258-6047-9	Labetalol Hydrochloride	90 in 1 PACKAGE	TABLET, FILM COATED	90		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Labetalol Hydrochloride	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
LABETALOL	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-6047	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 2 package rows	20131107_167c5861-c51b-45b2-9973-8e02e6ffc041.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	BluePoint Laboratories	e4562c70-f245-4dbe-8fe1-0bb64a91a315	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074787 application number: ANDA074787
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NorthStar Rx LLC	5bd81a8a-a480-4c8d-bd4f-3158412e6a73	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074787 application number: ANDA074787
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	bf84ebae-3c91-4448-b1db-8e5ed3053866	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074787 application number: ANDA074787
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Chartwell RX, LLC	ac439c08-1e47-4306-8308-b31d7a1a443c	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074787 application number: ANDA074787

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
896762	labetalol HCl 200 MG Oral Tablet	PSN	167c5861-c51b-45b2-9973-8e02e6ffc041	2
896762	labetalol hydrochloride 200 MG Oral Tablet	SCD	167c5861-c51b-45b2-9973-8e02e6ffc041	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-6047-3	68258604703	30 in 1 BOTTLE	Historical
68258-6047-9	68258604709	90 in 1 PACKAGE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LABETALOL HYDROCHLORIDE TABLETS USP Rx only	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-11-07	HUMAN PRESCRIPTION DRUG LABEL	2