LABETALOL HYDROCHLORIDE

Product NDC: 72888-468
11-digit product format: 728880468
Labeler code: 72888
Product ID: 72888-468_4e7597b8-afba-8b90-e063-6394a90a85e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advagen Pharma Ltd
Application: ANDA211953
Marketing category: ANDA
Marketing start: 2025-05-20
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 43.

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	Approval date
A211953-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18
A211953-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18
A211953-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211953-001	AB
A211953-002	AB
A211953-003	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 3 · 105 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
2026-09-14 22:38:34	2026-08	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211953-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211953-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211953-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211953-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211953-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211953-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211953-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211953-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211953-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211953-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211953-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211953-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211953-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211953-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211953-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211953-001	AB	1	`301d65b070ca…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
106a0959-5830-489f-ba60-afd4eb0fac36	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	Strength	SPL version
72888-468-01	LABETALOL HYDROCHLORIDE	500 in 1 BOTTLE	TABLET, FILM COATED	500		2
72888-468-02	LABETALOL HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72888-468-01	EA - Each	72888-468	958a9d45-a611-4d77-909f-51d715a82cae	1	2025-07-08
72888-468-02	EA - Each	72888-468	14f68446-c500-4291-bda0-cb9a05aa0564	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72888-468	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ADVAGEN PHARMA LTD]	1	Current NDC, 2 package rows	20250523_106a0959-5830-489f-ba60-afd4eb0fac36.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	ed2293f8-2b82-c3db-e053-2995a90ad46c	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	fffb7c59-ad92-4e74-850d-d94d42b7fdc9	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	04f9dcdf-4023-48ee-9e7d-ca9366d9db72	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	ae5d7b3b-e444-48d3-9d85-9b07319f9374	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Advagen Pharma Ltd	106a0959-5830-489f-ba60-afd4eb0fac36	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953 ndc (product): 72888-468
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Advagen Pharma Ltd	1c680447-b43a-4ff1-bc64-2c2174ca1c9a	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Redpharm Drug	32525ed4-3cca-2b99-e063-6294a90a6c66	2025-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	e6836a01-220d-4b69-9b4a-c919daeb6ece	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	1a71964e-e6fa-443e-bfdd-f8852f8cf29e	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	c586ab65-56e8-4a4f-b471-902198d3e58c	2023-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953

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
896766	labetalol HCl 300 MG Oral Tablet	PSN	106a0959-5830-489f-ba60-afd4eb0fac36	2
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	106a0959-5830-489f-ba60-afd4eb0fac36	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72888-468-01	72888046801	500 TABLET, FILM COATED in 1 BOTTLE (72888-468-01)	2025-05-20	No	No	Current
72888-468-02	72888046802	100 TABLET, FILM COATED in 1 BOTTLE (72888-468-02)	2025-05-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets USP Rx only	Advagen Pharma Ltd \| Rubicon Research Limited	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	2