Metoprolol Tartrate

Product NDC
68071-1795
Requested package NDC
68071-1795-1
11-digit product format
680711795
Labeler code
68071
Product ID
68071-1795_bb18e6d8-d995-60ca-e053-2a95a90ab663
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077739
Marketing category
ANDA
Marketing start
2007-09-11
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-179568071-1795-1DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077739-001METOPROLOL TARTRATEMETOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-11
A077739-002METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-11
A077739-003METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-11
A077739-004METOPROLOL TARTRATEMETOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-07
A077739-005METOPROLOL TARTRATEMETOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A077739-001AB
A077739-002AB
A077739-003AB
A077739-004AB
A077739-005AB

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 · 167 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-0784e616aacf4f…
2026-09-14 22:38:342026-08A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-0784e616aacf4f…
2026-08-18 06:07:402026-07A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-0703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 167 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077739-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077739-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077739-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077739-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A077739-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A077739-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077739-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077739-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077739-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077739-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077739-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077739-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-005AB103ed91905a0d…

FDA-Initiated Inactive NDC Indexing#

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.c9ccdbc0-0e4e-40c4-aacf-de60deda9fd52026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.3a236293-35c1-4083-9805-ab40df5350832026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.028b6e4a-1597-4d21-89d0-0bbbad21efa82026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEAmerican Health Packaging0a3ccfd4-8b65-4c7e-b0ba-27ff40d5b5e82026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.ad7a07a1-a05f-4eee-ba0a-69675ffbb6e82026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATELegacy Pharmaceutical Packaging, LLC20cc66c0-a00b-4643-9819-6e0daed51e5f2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEA-S Medication Solutionse1bb16fa-4f72-44bc-bc33-d7653c13f55c2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEA-S Medication Solutions5b423eba-0a35-41b0-9338-fa4c6f5c6c7f2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.18f44ba2-d431-4a73-ac78-83e734fde6942026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.d3628f24-8076-4980-a358-8445ef8260f42026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.19678edf-934a-45f3-b5da-94d10e9b32482026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATENuCare Pharmaceuticals, Inc.47d18ba7-558d-1190-e063-6294a90a958f2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATENorthwind Health Company, LLCf318d14a-9f96-4238-e053-2995a90abc152026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATENorthwind Health Company, LLCf319e981-81ff-22da-e053-2a95a90a27382026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATENorthwind Health Company, LLCd9cbda2a-70d9-74d3-e053-2a95a90aacc12026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEQPharma Inc2ad0606c-7a90-44bd-a75d-d256de30fbcf2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEQPharma Inc85a638c3-d53c-453d-935c-fcfd31372a452025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEQPharma, Inc.c0e147a8-36a6-1e61-e053-2a95a90afd622025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.f4a4da81-c4d0-4a00-9f08-9029b5d9b5ea2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.00de1f16-f979-4dbf-aa60-246ffac8d4102025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-1795-168071179501100 TABLET, FILM COATED in 1 BOTTLE (68071-1795-1) 2017-07-170000-00-00NoNoCurrent