Lopressor

Product NDC: 30698-459
11-digit product format: 306980459
Labeler code: 30698
Product ID: 30698-459_28c4fc69-5609-49ec-8fe5-4d7bc8f88288
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metoprolol tartrate
Dosage form: TABLET
Route: ORAL
Labeler: Validus Pharmaceuticals LLC
Application: NDA017963
Marketing category: NDA
Marketing start: 2014-05-05
Substance: METOPROLOL TARTRATE
Active strength: 100 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017963-001	LOPRESSOR	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017963-002	LOPRESSOR	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N017963-001	AB
N017963-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017963-001	LOPRESSOR	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017963-002	LOPRESSOR	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017963-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017963-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017963-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017963-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017963-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017963-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017963-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017963-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017963-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017963-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017963-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017963-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017963-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017963-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017963-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017963-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017963-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017963-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017963-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017963-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017963-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017963-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017963-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017963-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017963-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017963-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017963-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017963-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017963-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017963-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017963-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017963-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017963-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017963-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017963-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017963-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017963-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017963-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017963-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017963-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lopressor
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOPROLOL TARTRATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W5S57Y3A5L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866511	Internal RxNorm lookup
866513	Internal RxNorm lookup
866514	Internal RxNorm lookup
866516	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0283bc9d-6998-493a-824a-d4c85f704111	Available on FDA.report

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
30698-459-01	Lopressor	100 in 1 BOTTLE	TABLET	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
30698-459-01	EA - Each	30698-459	063dac93-6de7-44f8-a1b7-ed2f6d30c08c	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METOPROLOL TARTRATE	ACTIVE INGREDIENT	W5S57Y3A5L	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
LACTOSE, UNSPECIFIED FORM	INACTIVE INGREDIENT	J2B2A4N98G	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
30698-459	LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]	10	Current NDC, Legacy NDC, 1 package rows	20240131_0283bc9d-6998-493a-824a-d4c85f704111.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lopressor	METOPROLOL TARTRATE	Validus Pharmaceuticals LLC	0283bc9d-6998-493a-824a-d4c85f704111	2023-09-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017963 application number: NDA017963 ndc (product): 30698-459

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
866513	Lopressor 100 MG Oral Tablet	PSN	0283bc9d-6998-493a-824a-d4c85f704111	10
866516	Lopressor 50 MG Oral Tablet	PSN	0283bc9d-6998-493a-824a-d4c85f704111	10
866511	metoprolol tartrate 100 MG Oral Tablet	PSN	0283bc9d-6998-493a-824a-d4c85f704111	10
866514	metoprolol tartrate 50 MG Oral Tablet	PSN	0283bc9d-6998-493a-824a-d4c85f704111	10
866513	metoprolol tartrate 100 MG Oral Tablet [Lopressor]	SBD	0283bc9d-6998-493a-824a-d4c85f704111	10
866516	metoprolol tartrate 50 MG Oral Tablet [Lopressor]	SBD	0283bc9d-6998-493a-824a-d4c85f704111	10
866511	metoprolol tartrate 100 MG Oral Tablet	SCD	0283bc9d-6998-493a-824a-d4c85f704111	10
866514	metoprolol tartrate 50 MG Oral Tablet	SCD	0283bc9d-6998-493a-824a-d4c85f704111	10
866513	Lopressor 100 MG Oral Tablet	SY	0283bc9d-6998-493a-824a-d4c85f704111	10
866516	Lopressor 50 MG Oral Tablet	SY	0283bc9d-6998-493a-824a-d4c85f704111	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
30698-459-01	30698045901	100 TABLET in 1 BOTTLE (30698-459-01)	100 tablet	2014-05-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lopressor - Validus Pharmaceuticals LLC	Validus Pharmaceuticals LLC	2023-09-14	HUMAN PRESCRIPTION DRUG LABEL	10