Labetalol hydrochloride

Product NDC: 0591-0607
Requested package NDC: 0591-0607-05
11-digit product format: 005910607
Labeler code: 0591
Product ID: 0591-0607_d5dfcb69-d2c4-49ca-a684-83c9e15b3b06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA075133
Marketing category: ANDA
Marketing start: 1998-08-03
Marketing end: 2026-05-31
Substance: LABETALOL HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0591-0607	0591-0607-05	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-0607	0591-0607-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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	Approval date
A075133-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03
A075133-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03
A075133-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075133-001	AB
A075133-002	AB
A075133-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1998-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075133-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1998-08-03	`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	A075133-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075133-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075133-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075133-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075133-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075133-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075133-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075133-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075133-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075133-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075133-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075133-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075133-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075133-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075133-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075133-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075133-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075133-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075133-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075133-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075133-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075133-001	AB	1	`1e350fbaab3a…`

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
0591-0607-01	Labetalol hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	16
0591-0607-05	Labetalol hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	16
0591-0607-10	Labetalol hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-0607-01	EA - Each	0591-0607	a5599636-e130-49f9-baae-a374fabe4222	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LABETALOL HYDROCHLORIDE	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LABETALOL	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
WATER	INACTIVE INGREDIENT	059QF0KO0R	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LABETALOL HYDROCHLORIDE	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
LABETALOL	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	9
LABETALOL HYDROCHLORIDE	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
LABETALOL	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	6
LABETALOL HYDROCHLORIDE	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
LABETALOL HYDROCHLORIDE	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
LABETALOL HYDROCHLORIDE	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LABETALOL	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
LABETALOL	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LABETALOL	ACTIVE MOIETY	R5H8897N95	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-0607	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	15	Current NDC, Legacy NDC, 3 package rows	20181129_a5b65a9b-6b8a-48a4-9c72-0e605bb309eb.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	A-S Medication Solutions	a007d945-417c-4647-ab03-95ca219d7d38	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075133 application number: ANDA075133
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	83a6e770-207a-46bc-992d-c1ad90d1006d	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075133 application number: ANDA075133
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	Proficient Rx LP	c0301841-e209-4242-bace-58a20e6dd01b	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075133 application number: ANDA075133
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	Actavis Pharma, Inc.	a5b65a9b-6b8a-48a4-9c72-0e605bb309eb	2015-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075133 application number: ANDA075133 ndc (package): 0591-0607-05 ndc (product): 0591-0607 ndc11 (package): 00591060705

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	a5b65a9b-6b8a-48a4-9c72-0e605bb309eb	16
896762	labetalol HCl 200 MG Oral Tablet	PSN	a5b65a9b-6b8a-48a4-9c72-0e605bb309eb	16
896766	labetalol HCl 300 MG Oral Tablet	PSN	a5b65a9b-6b8a-48a4-9c72-0e605bb309eb	16
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	a5b65a9b-6b8a-48a4-9c72-0e605bb309eb	16
896762	labetalol hydrochloride 200 MG Oral Tablet	SCD	a5b65a9b-6b8a-48a4-9c72-0e605bb309eb	16
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	a5b65a9b-6b8a-48a4-9c72-0e605bb309eb	16
896762	labetalol HCl 200 MG Oral Tablet	PSN	88ff4e25-bef7-4a8b-a292-23878baac116	1
896766	labetalol HCl 300 MG Oral Tablet	PSN	7b09b29d-095d-4bf3-b991-8123c14d7a00	1
896766	labetalol HCl 300 MG Oral Tablet	PSN	88ff4e25-bef7-4a8b-a292-23878baac116	1
896762	labetalol hydrochloride 200 MG Oral Tablet	SCD	88ff4e25-bef7-4a8b-a292-23878baac116	1
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	7b09b29d-095d-4bf3-b991-8123c14d7a00	1
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	88ff4e25-bef7-4a8b-a292-23878baac116	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-0607-05	00591060705	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0607-05)	1998-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only	A-S Medication Solutions	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL	1
Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only	Major Pharmaceuticals	2021-09-10	HUMAN PRESCRIPTION DRUG LABEL	15
Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	1011
Labetalol Hydrochloride Tablets, USP Revised: December 2015 Rx Only	Golden State Medical Supply, Inc.	2018-11-06	HUMAN PRESCRIPTION DRUG LABEL	4
Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only	Actavis Pharma, Inc.	2015-12-31	HUMAN PRESCRIPTION DRUG LABEL	15
Labetalol Hydrochloride Tablets USP Revised : July 2008 Rx only 2000623	Rebel Distributors Corp	2011-09-21	HUMAN PRESCRIPTION DRUG LABEL	1
LABETALOL HYDROCHLORIDE - STAT RX USA LLC	STAT RX USA LLC	2011-09-01	HUMAN PRESCRIPTION DRUG LABEL	1