METOPROLOL

Product NDC
83270-177
Requested package NDC
83270-177-10
11-digit product format
832700177
Labeler code
83270
Product ID
83270-177_571d8a14-0118-d00c-e063-6394a90a2769
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate Injection
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Oneosource Specialty Pharma Limited
Application
ANDA090317
Marketing category
ANDA
Marketing start
2026-04-30
Substance
METOPROLOL TARTRATE
Active strength
5 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090317-001METOPROLOL TARTRATEMETOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-1984e616aacf4f…
2026-08-18 06:07:402026-07A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2010-04-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2010-04-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2010-04-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2010-04-193f01610625f2…
2019-09-15 20:21 UTC2019-09A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2010-04-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2010-04-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090317-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTION2010-04-19f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090317-001AP174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A090317-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090317-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090317-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A090317-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090317-001AP1ea99ee380514…

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
METOPROLOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W5S57Y3A5LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866508Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
05946833-9d66-4832-a0d8-b91b1ff01b8bAvailable on FDA.report

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METOPROLOLMETOPROLOL TARTRATE INJECTIONOneosource Specialty Pharma Limited05946833-9d66-4832-a0d8-b91b1ff01b8b2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090317
application number: ANDA090317
ndc (package): 83270-177-10
ndc (product): 83270-177
ndc11 (package): 83270017710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83270-177-108327001771010 VIAL in 1 CARTON (83270-177-10) / 5 mL in 1 VIAL (83270-177-01) 10 vial2026-04-30NoNoCurrent