Application 074787

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	200MG	No	No
003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	300MG	No	No
004	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 3 of 4 · 136 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
2020-12-22 03:56 UTC	2020-12	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		1998-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		1998-08-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		1998-08-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		1998-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074787-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074787-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074787-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A074787-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074787-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074787-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074787-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074787-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074787-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074787-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074787-004	AB	1	`84e616aacf4f…`
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…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Coupler LLC	5954cc5c-3e73-e039-e063-6394a90a7d6a	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074787 application number: ANDA074787
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 ndc (product): 23155-724 ndc (product): 23155-725 ndc (product): 23155-723
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-4539	Labetalol Hydrochloride	Labetalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7686	Labetalol Hydrochloride	Labetalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7687	Labetalol Hydrochloride	Labetalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7688	Labetalol Hydrochloride	Labetalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
23155-723	Labetalol Hydrochloride	Labetalol Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-723	Labetalol Hydrochloride	Labetalol Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-724	Labetalol Hydrochloride	Labetalol Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-724	Labetalol Hydrochloride	Labetalol Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-725	Labetalol Hydrochloride	Labetalol Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-725	Labetalol Hydrochloride	Labetalol Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
50436-4365	Labetalol Hydrochloride	Labetalol Hydrochloride	Unit Dose Services	ANDA	Current
68258-6047	Labetalol Hydrochloride	Labetalol Hydrochloride	Dispensing Solutions, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39441	ORIG	2004-06-08
22370	ORIG	2003-08-01
30698	ORIG	1998-08-03