Labetalol Hydrochloride

Product NDC: 68382-800
11-digit product format: 683820800
Labeler code: 68382
Product ID: 68382-800_49639538-dfdd-4312-9664-701e8bdbe191
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA207743
Marketing category: ANDA
Marketing start: 2017-12-05
Substance: LABETALOL HYDROCHLORIDE
Active strength: 300 mg/1
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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207743-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19
A207743-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2017-09-19
A207743-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207743-001	AB
A207743-002	AB
A207743-003	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A207743-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207743-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207743-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207743-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207743-001	AB	1	`1e350fbaab3a…`

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	300 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
896758	Internal RxNorm lookup
896762	Internal RxNorm lookup
896766	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
5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68382-800-01	Labetalol Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	5
68382-800-05	Labetalol Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	5
68382-800-06	Labetalol Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
68382-800-16	Labetalol Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-800-01	EA - Each	68382-800	950b148e-0788-4544-bc56-d688e5f8eac1	1	2018-04-19
68382-800-05	EA - Each	68382-800	39f81004-0574-41c6-b54c-88aa0cc73234	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-800	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	4	Current NDC, Legacy NDC, 4 package rows	20221014_5942a5a8-c3c1-4ecb-921e-9bc92393bdf8.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	BluePoint Laboratories Inc.	63ede355-42ec-4c52-a941-51e5f6b35ed6	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	9c3bb751-c425-43ff-b530-2460b568b689	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743 ndc (product): 68382-800
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Cardinal Health 107, LLC	63db5b00-e864-4b2d-84f2-00bf35211b9b	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	American Health Packaging	3004aa59-288c-4971-b77b-78789715ef5a	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Lifesciences Limited	a3c0cc1e-1c01-4009-afdc-d35a66546aec	2024-11-30		Exact identifier application applno (ANDA): 207743 application number: ANDA207743

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
896758	labetalol HCl 100 MG Oral Tablet	PSN	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	5
896762	labetalol HCl 200 MG Oral Tablet	PSN	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	5
896766	labetalol HCl 300 MG Oral Tablet	PSN	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	5
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	5
896762	labetalol hydrochloride 200 MG Oral Tablet	SCD	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	5
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-800-01	68382080001	100 TABLET, FILM COATED in 1 BOTTLE (68382-800-01)	2017-12-05	0000-00-00	No	No	Current
68382-800-05	68382080005	500 TABLET, FILM COATED in 1 BOTTLE (68382-800-05)	2017-12-05	0000-00-00	No	No	Current
68382-800-06	68382080006	30 TABLET, FILM COATED in 1 BOTTLE (68382-800-06)	2017-12-05	0000-00-00	No	No	Current
68382-800-16	68382080016	90 TABLET, FILM COATED in 1 BOTTLE (68382-800-16)	2017-12-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets, USP Rx only	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	5
Labetalol Hydrochloride Tablets, USP Rx only	Major Pharmaceuticals	2024-07-05	HUMAN PRESCRIPTION DRUG LABEL	2