Labetalol Hydrochloride

Product NDC: 47781-586
Requested package NDC: 47781-586-29
11-digit product format: 477810586
Labeler code: 47781
Product ID: 47781-586_31b2325f-63aa-a3ef-4b01-59e3ab3aba2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Alvogen Inc.
Application: ANDA090699
Marketing category: ANDA
Marketing start: 2017-06-01
Marketing end: 0000-00-00
Substance: LABETALOL HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	47781-586	47781-586-29	D	Discontinued by firm		2026-08-03

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 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090699-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP		2012-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090699-001	AP

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090699-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090699-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090699-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090699-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090699-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090699-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090699-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090699-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090699-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090699-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090699-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090699-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090699-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090699-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090699-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090699-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090699-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090699-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090699-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090699-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090699-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090699-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090699-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090699-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090699-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090699-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090699-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090699-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090699-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090699-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090699-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090699-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090699-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090699-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090699-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090699-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090699-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090699-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090699-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090699-001	AP	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-586-29	ML - Milliliter	47781-586	829b60e6-ab01-41d8-8cdb-53507e6288e4	1	2017-07-07
47781-586-56	ML - Milliliter	47781-586	835dd71d-f238-43a8-9984-ba07ce5efe68	1	2017-07-07

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	Mullan Pharmaceutical Inc.	fb5ef3ba-0a7e-4f41-9547-d734983da0d3	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090699 application number: ANDA090699
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Gland Pharma Limited	48caf986-3126-48e1-afcd-16d65c9cfe00	2024-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090699 application number: ANDA090699
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Fosun Pharma USA Inc.	4a5ffab2-a3b8-411e-992d-7f38d508643a	2024-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090699 application number: ANDA090699
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Fosun Pharma USA Inc.	f18dff28-f6f5-4ecb-9797-25062e247559	2021-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090699 application number: ANDA090699

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
47781-586-29	47781058629	1 VIAL, MULTI-DOSE in 1 CARTON (47781-586-29) > 20 mL in 1 VIAL, MULTI-DOSE	2017-06-01	0000-00-00	No	No	Current