Metoprolol succinate

Product NDC
72516-027
11-digit product format
725160027
Labeler code
72516
Product ID
72516-027_52af10c8-c2f0-56aa-e063-6394a90ad5ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Oryza pharmaceuticals Inc.
Application
ANDA214110
Marketing category
ANDA
Marketing start
2025-07-21
Substance
METOPROLOL SUCCINATE
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214110-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26
A214110-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26
A214110-003METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26
A214110-004METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2026-05-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A214110-001AB
A214110-002AB
A214110-003AB
A214110-004AB

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 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2684e616aacf4f…
2026-09-14 22:38:342026-08A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2684e616aacf4f…
2026-09-14 22:38:342026-08A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2684e616aacf4f…
2026-09-14 22:38:342026-08A214110-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2026-05-1584e616aacf4f…
2026-08-18 06:07:402026-07A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07A214110-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2026-05-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A214110-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214110-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214110-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2024-07-2679d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214110-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A214110-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A214110-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A214110-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A214110-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214110-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214110-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214110-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214110-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214110-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214110-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214110-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214110-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214110-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214110-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214110-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214110-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214110-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214110-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214110-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214110-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214110-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214110-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214110-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214110-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214110-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214110-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214110-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214110-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214110-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214110-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214110-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214110-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214110-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214110-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214110-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214110-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214110-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214110-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214110-002AB179d66fd596c7…

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol succinate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TH25PD4CCBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866412Internal RxNorm lookup
866419Internal RxNorm lookup
866436Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
151079c5-6360-45ed-8118-885543d6a4adAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4fProduct name120260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
07ea0487-5434-6896-2497-013a7ee4afbdProduct name920250311
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72516-027-01Metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
72516-027-10Metoprolol succinate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004
72516-027-50Metoprolol succinate500 in 1 BOTTLETABLET, EXTENDED RELEASE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72516-027-10EA - Each72516-027f0775fdc-5e35-4fae-80db-eae3abd273b912025-11-13

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepacka693bef9-cdfa-4012-ac87-873b9c5bf1cd2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214110
application number: ANDA214110
Metoprolol succinateMETOPROLOL SUCCINATECoupler LLC55f1a53b-8ec1-8373-e063-6394a90a896c2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214110
application number: ANDA214110
Metoprolol succinateMETOPROLOL SUCCINATEOryza pharmaceuticals Inc.151079c5-6360-45ed-8118-885543d6a4ad2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214110
application number: ANDA214110
ndc (product): 72516-027
Metoprolol succinateMETOPROLOL SUCCINATEZhejiang Jutai Pharamceutical Co., Ltd4df90eca-70e3-5c7c-e063-6294a90adc412026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214110
application number: ANDA214110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN151079c5-6360-45ed-8118-885543d6a4ad4
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN151079c5-6360-45ed-8118-885543d6a4ad4
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN151079c5-6360-45ed-8118-885543d6a4ad4
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD151079c5-6360-45ed-8118-885543d6a4ad4
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD151079c5-6360-45ed-8118-885543d6a4ad4
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD151079c5-6360-45ed-8118-885543d6a4ad4
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY151079c5-6360-45ed-8118-885543d6a4ad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72516-027-0172516002701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-027-01) 2025-07-21NoNoCurrent
72516-027-10725160027101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-027-10) 2025-07-21NoNoCurrent
72516-027-5072516002750500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-027-50) 2025-07-21NoNoCurrent