TOPROL

Product NDC
71610-035
11-digit product format
716100035
Labeler code
71610
Product ID
71610-035_f94f454a-2f40-4d6b-8936-57fad107a20b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA019962
Marketing category
NDA
Marketing start
2018-01-01
Substance
METOPROLOL SUCCINATE
Active strength
25 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 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
N019962-001TOPROL-XLMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10
N019962-002TOPROL-XLMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10
N019962-003TOPROL-XLMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10
N019962-004TOPROL-XLMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019962-001AB
N019962-002AB
N019962-003AB
N019962-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-0584e616aacf4f…
2026-08-18 06:07:402026-07N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N019962-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N019962-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N019962-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N019962-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N019962-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019962-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019962-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019962-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019962-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019962-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TOPROL
Brand name suffix
XL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE25 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866427Internal RxNorm lookup
866429Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a07891a5-152e-4a38-8179-e05a90458a7dAvailable 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
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
71610-035-45TOPROLXL45 in 1 BOTTLETABLET, EXTENDED RELEASE451
71610-035-60TOPROLXL90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-035-45EA - Each71610-03563a15c76-66a4-4219-ab61-0e27d50ad8c612018-04-19
71610-035-60EA - Each71610-0356fb10365-a9d5-4e2c-9bed-22660b47dd9a12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-035TOPROL XL (METOPROLOL SUCCINATE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20180221_a07891a5-152e-4a38-8179-e05a90458a7d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOPROL XLMETOPROLOL SUCCINATEMelinta Therapeutics, LLC496ddfaa-7c9c-4888-b747-a210249b367a2026-03-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 019962
application number: NDA019962
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEProficient Rx LPe236f1ed-b400-4854-81c7-64964422a2f72019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019962
application number: NDA019962
TOPROL XLMETOPROLOL SUCCINATEAphena Pharma Solutions - Tennessee, LLCa07891a5-152e-4a38-8179-e05a90458a7d2018-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019962
application number: NDA019962
ndc (product): 71610-035

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNa07891a5-152e-4a38-8179-e05a90458a7d1
866429Toprol XL 25 MG 24HR Extended Release Oral TabletPSNa07891a5-152e-4a38-8179-e05a90458a7d1
86642924 HR metoprolol succinate 25 MG Extended Release Oral Tablet [Toprol]SBDa07891a5-152e-4a38-8179-e05a90458a7d1
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDa07891a5-152e-4a38-8179-e05a90458a7d1
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYa07891a5-152e-4a38-8179-e05a90458a7d1
86642924 HR Toprol 25 MG Extended Release Oral TabletSYa07891a5-152e-4a38-8179-e05a90458a7d1
86642924 HR Toprol XL 25 MG Extended Release Oral TabletSYa07891a5-152e-4a38-8179-e05a90458a7d1
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYa07891a5-152e-4a38-8179-e05a90458a7d1
866429Toprol XL (metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate)) 24 HR Extended Release Oral TabletSYa07891a5-152e-4a38-8179-e05a90458a7d1
866429Toprol XL 25 MG 24 HR Extended Release Oral TabletSYa07891a5-152e-4a38-8179-e05a90458a7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-035-457161000354545 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-035-45) 2018-01-260000-00-00NoNoCurrent
71610-035-607161000356090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-035-60) 2018-01-260000-00-00NoNoCurrent