Metoprolol tartrate

Product NDC: 57664-477
11-digit product format: 576640477
Labeler code: 57664
Product ID: 57664-477_efa4b809-f526-5cd8-e053-2a95a90afeae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoprolol tartrate
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA074644
Marketing category: ANDA
Marketing start: 2015-06-29
Marketing end: 0000-00-00
Substance: METOPROLOL TARTRATE
Active strength: 50 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4f	Product name	1	20260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
07ea0487-5434-6896-2497-013a7ee4afbd	Product name	9	20250311
95ced987-af5e-4bea-8119-4e7d4558d21b	Product name	2	20200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
9ab5a42a-e77d-486b-bb1f-b343fe664ada	Product name	1	20180430
310125de-e7c0-730d-d178-98b990a0334a	Product name	2	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57664-477-08	2020-01-31	C162847	48780-1	9d75b9d0-268c-f424-e053-dadaa90a57ce	c9a87c39-4baf-43e2-b6bc-3634f1eb77cf
57664-477-18	2020-01-31	C162847	48780-1	9d75b9d0-268c-f424-e053-dadaa90a57ce	c9a87c39-4baf-43e2-b6bc-3634f1eb77cf

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-477-08	EA - Each	57664-477	39b38134-be07-4843-822c-80b853c3b1d5	1	2015-12-02
57664-477-18	EA - Each	57664-477	71bf00a2-d664-4e69-8013-0c73b670346e	1	2015-12-02
57664-477-52	EA - Each	57664-477	2d5a8297-374d-4ab4-9da7-7525b33a733a	1	2012-07-24
57664-477-58	EA - Each	57664-477	b4a7c87a-d463-4d12-b232-c86c17243c33	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METOPROLOL TARTRATE	ACTIVE INGREDIENT	W5S57Y3A5L	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13
METOPROLOL TARTRATE	ACTIVE INGREDIENT	W5S57Y3A5L	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METOPROLOL TARTRATE TABLET [MED-HEALTH PHARMA, LLC]	3
METOPROLOL TARTRATE	ACTIVE INGREDIENT	W5S57Y3A5L	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METOPROLOL TARTRATE TABLET [TYA PHARMACEUTICALS]	2
Metoprolol tartrate	ACTIVE INGREDIENT	W5S57Y3A5L	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
METOPROLOL TARTRATE	ACTIVE INGREDIENT	W5S57Y3A5L	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
metoprolol	ACTIVE MOIETY	GEB06NHM23	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METOPROLOL TARTRATE TABLET [DIRECT RX]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	METOPROLOL TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METOPROLOL TARTRATE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-477	METOPROLOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	20	Legacy NDC	20240201_6ae551f6-b6cc-46df-b3d7-eb2963295e0a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W5S57Y3A5L	METOPROLOL TARTRATE	56392-17-7	METOPROLOL TARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866514	metoprolol tartrate 50 MG Oral Tablet	PSN	77b7b111-641c-4c1e-8412-0ada79ad25fb	7
866514	metoprolol tartrate 50 MG Oral Tablet	SCD	77b7b111-641c-4c1e-8412-0ada79ad25fb	7
866511	metoprolol tartrate 100 MG Oral Tablet	PSN	c30b8c70-4d7e-4960-a7cf-5257a1a89bf1	3
866514	metoprolol tartrate 50 MG Oral Tablet	PSN	c30b8c70-4d7e-4960-a7cf-5257a1a89bf1	3
866511	metoprolol tartrate 100 MG Oral Tablet	SCD	c30b8c70-4d7e-4960-a7cf-5257a1a89bf1	3
866514	metoprolol tartrate 50 MG Oral Tablet	SCD	c30b8c70-4d7e-4960-a7cf-5257a1a89bf1	3
866514	metoprolol tartrate 50 MG Oral Tablet	PSN	aaf37a9b-7017-49d7-aabf-a538d4d501f6	2
866514	metoprolol tartrate 50 MG Oral Tablet	SCD	aaf37a9b-7017-49d7-aabf-a538d4d501f6	2
866511	metoprolol tartrate 100 MG Oral Tablet	PSN	8ff18a70-965a-4d3e-ae3e-b599c4e6763c	1
866924	metoprolol tartrate 25 MG Oral Tablet	PSN	8ff18a70-965a-4d3e-ae3e-b599c4e6763c	1
866514	metoprolol tartrate 50 MG Oral Tablet	PSN	8ff18a70-965a-4d3e-ae3e-b599c4e6763c	1
866511	metoprolol tartrate 100 MG Oral Tablet	SCD	8ff18a70-965a-4d3e-ae3e-b599c4e6763c	1
866924	metoprolol tartrate 25 MG Oral Tablet	SCD	8ff18a70-965a-4d3e-ae3e-b599c4e6763c	1
866514	metoprolol tartrate 50 MG Oral Tablet	SCD	8ff18a70-965a-4d3e-ae3e-b599c4e6763c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-477-52	57664047752	100 TABLET in 1 BOTTLE (57664-477-52)	100 tablet	2015-06-29	0000-00-00	No	No	Current
57664-477-58	57664047758	1000 TABLET in 1 BOTTLE (57664-477-58)	1000 tablet	2015-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoprolol Tartrate	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2024-01-22	HUMAN PRESCRIPTION DRUG LABEL	20
METOPROLOL TARTRATE	Direct_Rx	2019-09-18	HUMAN PRESCRIPTION DRUG LABEL	7
Metoprolol Tartrate Tablets, USP Rx Only	TYA Pharmaceuticals	2013-03-25	Human Prescription Drug Label	2
Metoprolol Tartrate - Med-Health Pharma, LLC	Med-Health Pharma, LLC	2012-02-15	Human Prescription Drug Label	3
Metoprolol Tartrate	Rebel Distributors Corp.	2010-10-06	HUMAN PRESCRIPTION DRUG LABEL	1

Metoprolol tartrate

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#