Home NDC 0409-1778 Metoprolol Tartrate
Product NDC 0409-1778
11-digit product format 004091778
Labeler code 0409
Product ID 0409-1778_25fb7425-bc57-4216-8fc8-0bbec3d1125b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METOPROLOL TARTRATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA078085
Marketing category ANDA
Marketing start 2008-07-24
Substance METOPROLOL TARTRATE
Active strength 1 mg/mL
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-1778-35 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-1778-35 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0409-1778-35 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0409-1778-35 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0409-1778-35 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0409-1778-35 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0409-1778-35 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0409-1778-35 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0409-1778-35 0efc9e666f02…f202fb6c5f17…
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 A078085-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078085-001 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 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078085-001 METOPROLOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 2008-04-29 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 Tartrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOPROLOL TARTRATE 1 mg/mL
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 0409-1778-05 Metoprolol Tartrate 10 in 1 CARTON INJECTION, SOLUTION 10 29 0409-1778-15 Metoprolol Tartrate 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METOPROLOL TARTRATE ACTIVE INGREDIENT W5S57Y3A5L METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 15 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 15 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 15 WATER INACTIVE INGREDIENT 059QF0KO0R METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 15 METOPROLOL TARTRATE ACTIVE INGREDIENT W5S57Y3A5L METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 14 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 14 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 14 WATER INACTIVE INGREDIENT 059QF0KO0R METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 14 METOPROLOL TARTRATE ACTIVE INGREDIENT W5S57Y3A5L METOPROLOL TARTRATE INJECTION, SOLUTION [CARDINAL HEALTH] 1 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE INJECTION, SOLUTION [CARDINAL HEALTH] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X METOPROLOL TARTRATE INJECTION, SOLUTION [CARDINAL HEALTH] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1778 METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 28 Current NDC, Legacy NDC, 2 package rows 20241129_7c1f998a-233d-4feb-6ea2-457702abd0d2.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Metoprolol Tartrate METOPROLOL TARTRATE Cardinal Health 107, LLC a670d75a-ec69-4570-a3be-c57b896fc553 2026-06-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078085 application number: ANDA078085 Metoprolol Tartrate METOPROLOL TARTRATE Hospira, Inc. 7c1f998a-233d-4feb-6ea2-457702abd0d2 2026-05-21 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078085 application number: ANDA078085 ndc (product): 0409-1778 Metoprolol Tartrate METOPROLOL TARTRATE Hospira, Inc. f65e93ec-4db6-44fa-bff1-8ae89aa8243f 2026-05-04 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078085 application number: ANDA078085 Metoprolol Tartrate METOPROLOL TARTRATE ProPharma Distribution 3ef0affa-a2f7-92de-e063-6294a90ad4d0 2025-09-16 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078085 application number: ANDA078085 METOPROLOL TARTRATE METOPROLOL TARTRATE HF Acquisition Co LLC, DBA HealthFirst 99b22be0-d2b4-2449-e053-2995a90a6c28 2024-02-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078085 application number: ANDA078085
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 0409-1778-05 00409177805 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-1778-15) 2008-07-24 0000-00-00 No No Current 0409-1778-15 00409177815 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical