Labetalol Hydrochloride

Product NDC: 68083-111
11-digit product format: 680830111
Labeler code: 68083
Product ID: 68083-111_f3cca933-34c3-4efd-81c6-02a4920dda16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA090699
Marketing category: ANDA
Marketing start: 2012-04-19
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: 2026-12-31
Current FDA listing: Yes

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

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 · 42 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	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A090699-001	AP	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Labetalol Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LABETALOL HYDROCHLORIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1GEV3BAW9J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
896771	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48caf986-3126-48e1-afcd-16d65c9cfe00	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
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
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68083-111-01	Labetalol Hydrochloride	20 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	20	6
68083-111-01	Labetalol Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10	6
68083-111-02	Labetalol Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10	6
68083-111-02	Labetalol Hydrochloride	40 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	40	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Labetalol hydrochloride	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ]	3
Labetalol	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ]	3
Anhydrous Dextrose	INACTIVE INGREDIENT	5SL0G7R0OK	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ]	3
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ]	3
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ]	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ]	3
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-111	LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]	6	Current NDC, Legacy NDC, 4 package rows	20240522_48caf986-3126-48e1-afcd-16d65c9cfe00.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	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 ndc (product): 68083-111
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896771	labetalol HCl 5 MG/ML Injectable Solution	PSN	48caf986-3126-48e1-afcd-16d65c9cfe00	6
896771	labetalol hydrochloride 5 MG/ML Injectable Solution	SCD	48caf986-3126-48e1-afcd-16d65c9cfe00	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-111-01	68083011101	10 VIAL, GLASS in 1 CARTON (68083-111-01) / 20 mL in 1 VIAL, GLASS	2012-04-19	0000-00-00	No	No	Current
68083-111-02	68083011102	10 VIAL, GLASS in 1 CARTON (68083-111-02) / 40 mL in 1 VIAL, GLASS	2012-04-19	0000-00-00	No	No	Current