Labetalol Hydrochloride

Product NDC: 63629-2055
11-digit product format: 636292055
Labeler code: 63629
Product ID: 63629-2055_ed43928c-f814-4acf-855d-efcb5b7727e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207863
Marketing category: ANDA
Marketing start: 2019-05-24
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-2055		D	Discontinued by firm		2026-10-15
excluded package	package	63629-2055	63629-2055-1	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A207863-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04
A207863-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04
A207863-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207863-001	AB
A207863-002	AB
A207863-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A207863-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207863-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207863-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207863-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207863-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207863-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207863-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207863-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207863-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207863-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207863-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207863-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207863-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207863-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207863-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207863-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207863-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207863-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207863-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207863-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207863-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207863-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207863-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207863-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207863-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207863-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207863-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207863-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207863-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207863-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207863-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207863-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207863-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207863-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207863-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207863-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207863-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207863-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207863-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207863-003	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

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
63629-2055-1	Labetalol Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500		102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2055-1	EA - Each	63629-2055	e9cfb5db-4b8d-45b4-884d-ec1def62b16d	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2055	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	102	Legacy NDC, 1 package rows	20230306_ecb357ea-ba26-4d8a-b10a-5110f777414b.zip

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	ecb357ea-ba26-4d8a-b10a-5110f777414b	102
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	ecb357ea-ba26-4d8a-b10a-5110f777414b	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2055-1	63629205501	500 TABLET, FILM COATED in 1 BOTTLE (63629-2055-1)	2021-01-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets	Bryant Ranch Prepack	2023-03-02	HUMAN PRESCRIPTION DRUG LABEL	102