Metoprolol tartrate

Product NDC: 57664-166
11-digit product format: 576640166
Labeler code: 57664
Product ID: 57664-166_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
57664-166-08	2020-01-31	C162847	48780-1	9d75b9d0-268c-f424-e053-dadaa90a57ce	c9a87c39-4baf-43e2-b6bc-3634f1eb77cf
57664-166-18	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
57664-166-08	EA - Each	57664-166	c6c61c5a-20f6-456a-810e-c5c3d54cd1a1	1	2015-12-02
57664-166-18	EA - Each	57664-166	c3cdb942-18a1-429c-afeb-10f6c664b6bc	1	2015-12-02
57664-166-52	EA - Each	57664-166	5fddfe69-3077-4144-8688-1599666906b1	1	2012-07-24
57664-166-58	EA - Each	57664-166	89cac712-0be4-4455-ada9-4c47204fa9af	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 [PROFICIENT RX LP]	2
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]	2
METOPROLOL TARTRATE	ACTIVE INGREDIENT	W5S57Y3A5L	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
METOPROLOL TARTRATE	ACTIVE INGREDIENT	W5S57Y3A5L	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METOPROLOL TARTRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METOPROLOL TARTRATE TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-166	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
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
866511	metoprolol tartrate 100 MG Oral Tablet	PSN	eb4b7a1e-97c5-4b21-af68-485735bebb69	1
866514	metoprolol tartrate 50 MG Oral Tablet	PSN	490c6828-57f8-4dfd-bb3d-0cc51f3b781d	1
866514	metoprolol tartrate 50 MG Oral Tablet	PSN	52f26657-9fa7-4cee-bfa0-a07987b2f706	1
866514	metoprolol tartrate 50 MG Oral Tablet	PSN	eb4b7a1e-97c5-4b21-af68-485735bebb69	1
866511	metoprolol tartrate 100 MG Oral Tablet	SCD	eb4b7a1e-97c5-4b21-af68-485735bebb69	1
866514	metoprolol tartrate 50 MG Oral Tablet	SCD	490c6828-57f8-4dfd-bb3d-0cc51f3b781d	1
866514	metoprolol tartrate 50 MG Oral Tablet	SCD	52f26657-9fa7-4cee-bfa0-a07987b2f706	1
866514	metoprolol tartrate 50 MG Oral Tablet	SCD	eb4b7a1e-97c5-4b21-af68-485735bebb69	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-166-52	57664016652	100 TABLET in 1 BOTTLE (57664-166-52)	100 tablet	2015-06-29	0000-00-00	No	No	Current
57664-166-58	57664016658	1000 TABLET in 1 BOTTLE (57664-166-58)	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 Tablets, USP Rx Only	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
Metoprolol Tartrate Tablets, USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2018-08-09	HUMAN PRESCRIPTION DRUG LABEL	1
Metoprolol Tartrate Tablets, USP Rx Only	Blenheim Pharmacal, Inc.	2015-02-16	HUMAN PRESCRIPTION DRUG LABEL	1
Metoprolol Tartrate Tablets, USP Rx Only	State of Florida DOH Central Pharmacy	2014-09-30	HUMAN PRESCRIPTION DRUG LABEL	1
Metoprolol Tartrate - Med-Health Pharma, LLC	Med-Health Pharma, LLC	2012-02-15	Human Prescription Drug Label	3

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#