Labetalol Hydrochloride

Product NDC: 72485-515
Requested package NDC: 72485-515-01
11-digit product format: 724850515
Labeler code: 72485
Product ID: 72485-515_1b856828-2371-4bcc-adc0-146ac8b04460
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA214533
Marketing category: ANDA
Marketing start: 2026-09-15
Substance: LABETALOL HYDROCHLORIDE
Active strength: 100 mg/20mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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
A214533-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP		2021-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214533-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214533-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214533-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214533-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214533-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214533-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214533-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214533-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214533-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214533-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214533-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214533-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214533-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214533-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214533-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214533-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214533-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214533-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214533-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214533-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214533-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214533-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214533-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214533-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214533-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214533-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214533-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214533-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214533-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214533-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214533-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214533-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214533-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214533-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214533-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214533-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214533-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Labetalol Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LABETALOL HYDROCHLORIDE	100 mg/20mL

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Caplin Steriles Limited	77152699-1ca8-442a-8cb4-80b0ffbec6f2	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214533 application number: ANDA214533
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NorthStar Rx LLC	a2d07ec0-3718-40eb-9d0a-79c557c486b9	2023-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214533 application number: ANDA214533
labetalol hydrochloride	LABETALOL HYDROCHLORIDE	Sagent Pharmaceuticals	da8af6c2-d822-4ae5-9c2d-a1d161bdefd0	2022-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214533 application number: ANDA214533

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	Sample	Exclude flag	Status
72485-515-01	72485051501	1 VIAL, MULTI-DOSE in 1 CARTON (72485-515-01) / 20 mL in 1 VIAL, MULTI-DOSE	2026-09-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Injection, USP	Armas Pharmaceuticals Inc.	2026-07-08	HUMAN PRESCRIPTION DRUG LABEL	1