Labetalol Hydrochloride

Product NDC: 29300-254
11-digit product format: 293000254
Labeler code: 29300
Product ID: 29300-254_8325a41d-d05c-4c6b-b2fc-260c9380bfba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA212719
Marketing category: ANDA
Marketing start: 2022-10-01
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	Approval date
A212719-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08
A212719-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08
A212719-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	2022-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	2022-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	2022-08-08	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212719-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212719-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212719-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212719-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212719-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212719-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212719-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212719-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212719-003	AB	1	`e64feba35796…`

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
ed0188ba-3fd3-4680-a829-ba242a115fab	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
29300-254-01	Labetalol Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		4
29300-254-05	Labetalol Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-254	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3	Current NDC, Legacy NDC, 2 package rows	20221001_ed0188ba-3fd3-4680-a829-ba242a115fab.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	ed0188ba-3fd3-4680-a829-ba242a115fab	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212719 application number: ANDA212719 ndc (product): 29300-254

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	ed0188ba-3fd3-4680-a829-ba242a115fab	4
896762	labetalol HCl 200 MG Oral Tablet	PSN	ed0188ba-3fd3-4680-a829-ba242a115fab	4
896766	labetalol HCl 300 MG Oral Tablet	PSN	ed0188ba-3fd3-4680-a829-ba242a115fab	4
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	ed0188ba-3fd3-4680-a829-ba242a115fab	4
896762	labetalol hydrochloride 200 MG Oral Tablet	SCD	ed0188ba-3fd3-4680-a829-ba242a115fab	4
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	ed0188ba-3fd3-4680-a829-ba242a115fab	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-254-01	29300025401	100 TABLET, FILM COATED in 1 BOTTLE (29300-254-01)	2022-10-01	0000-00-00	No	No	Current
29300-254-05	29300025405	500 TABLET, FILM COATED in 1 BOTTLE (29300-254-05)	2022-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets, USP Rx only	Unichem Pharmaceuticals (USA), Inc.	2026-02-25	HUMAN PRESCRIPTION DRUG LABEL	4