Home NDC 63323-660 Metoprolol
Product NDC 63323-660
11-digit product format 633230660
Labeler code 63323
Product ID 63323-660_4066607a-15cb-42ac-999e-5254907dda5a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METOPROLOL TARTRATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA091045
Marketing category ANDA
Marketing start 2010-10-28
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091045-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091045-001 AP
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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091045-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2010-10-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Metoprolol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOPROLOL TARTRATE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W5S57Y3A5L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 866508 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-660-01 Metoprolol 5 mL in 1 VIAL INJECTION, SOLUTION 5 6 63323-660-05 Metoprolol 10 in 1 TRAY INJECTION, SOLUTION 10 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-660 METOPROLOL (METOPROLOL TARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 5 Current NDC, Legacy NDC, 2 package rows 20211117_be1c686e-37a5-4a53-945b-68a6ead35134.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-660-01 63323066001 5 mL in 1 VIAL 5 ml Historical 63323-660-05 63323066005 10 VIAL in 1 TRAY (63323-660-05) / 5 mL in 1 VIAL (63323-660-01) 10 vial 2010-10-28 0000-00-00 No No Current