Labetalol hydrochloride

Product NDC: 0591-0607
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

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 [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, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LABETALOL HYDROCHLORIDE	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	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
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	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 [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	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
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	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 [STAT RX USA LLC]	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
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	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 [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	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

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
0591-0607-01	00591060701	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0607-01)	1998-08-03	2026-05-31	No	No	Current
0591-0607-05	00591060705	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0607-05)	1998-08-03	0000-00-00	No	No	Current
0591-0607-10	00591060710	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0607-10)	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	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

Labetalol hydrochloride

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#