Metoprolol tartrate

Product NDC
67544-387
Requested package NDC
67544-387-80
11-digit product format
675440387
Labeler code
67544
Product ID
67544-387_4c117ff1-5215-4b0b-9b2d-449a31092f37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076670
Marketing category
ANDA
Marketing start
2015-06-29
Marketing end
0000-00-00
Substance
METOPROLOL TARTRATE
Active strength
25 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 packagepackage67544-38767544-387-80DDiscontinued by firm2026-08-11

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67544-38767544-387-80IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67544-38767544-387-80IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076670-001METOPROLOL TARTRATEMETOPROLOL TARTRATE25MGTABLET / ORAL2004-01-15

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076670-001METOPROLOL TARTRATE25MGTABLET / ORAL2004-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORAL2004-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076670-001METOPROLOL TARTRATE25MGTABLET / ORAL2004-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-153f01610625f2…
2019-09-15 20:21 UTC2019-09A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076670-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076670-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076670-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076670-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076670-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076670-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076670-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076670-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076670-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076670-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076670-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076670-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076670-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076670-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076670-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076670-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076670-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076670-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076670-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076670-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076670-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076670-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076670-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076670-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076670-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076670-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076670-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076670-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076670-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076670-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076670-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076670-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076670-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076670-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076670-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076670-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076670-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-387-30EA - Each67544-38759635b45-4d46-4b76-a82f-8247a9f871ec12018-10-11
67544-387-53EA - Each67544-3873ecffecd-2097-47be-b4fc-a7b90546565a12021-04-08
67544-387-60EA - Each67544-387123f09b3-6875-4509-a24e-44cc7a3350d412018-10-11
67544-387-70EA - Each67544-387f4a5f7f0-8886-42ef-9e9d-b9d13f9168fc12021-04-08
67544-387-80EA - Each67544-38726e4ceae-d7b8-4cbc-97d4-60053fb1ceb312018-10-11
67544-387-92EA - Each67544-3873d18b4fe-c3dc-433b-b258-069edcd13c3f12021-04-08
67544-387-98EA - Each67544-387c8a7c6b0-33b8-40a3-b429-e8401611bd2612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-387METOPROLOL TARTRATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20210323_3d428860-3dd1-42a3-8d5b-aa800b3e28b8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-387-8067544038780180 TABLET in 1 BOTTLE (67544-387-80) 180 tablet2018-07-030000-00-00NoNoCurrent