Home NDC 50419-188 Magnevist
Product NDC 50419-188
11-digit product format 504190188
Labeler code 50419
Product ID 50419-188_010f5383-4b59-426a-aa4f-674079edb44c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gadopentetate dimeglumine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Bayer HealthCare Pharmaceuticals Inc.
Application NDA021037
Marketing category NDA
Marketing start 2010-12-14
Marketing end 2022-05-30
Substance GADOPENTETATE DIMEGLUMINE
Active strength 469 mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 5 · 288 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021037-001 MAGNEVIST GADOPENTETATE DIMEGLUMINE 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD, RS 2000-03-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD, RS 2000-03-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021037-001 MAGNEVIST 469.01MG/ML INJECTABLE / INJECTION RLD 2000-03-10 cb3db0bc1861…
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50419-188-01 50419018801 20 CARTON in 1 BOX (50419-188-01) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE 20 carton 2014-06-11 2022-01-31 No No Current 50419-188-02 50419018802 20 CARTON in 1 BOX (50419-188-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 20 mL in 1 VIAL, SINGLE-DOSE 20 carton 2014-06-11 2022-01-31 No No Current 50419-188-05 50419018805 20 CARTON in 1 BOX (50419-188-05) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE 20 carton 2014-06-11 2022-07-31 No No Current 50419-188-11 50419018811 10 VIAL, PHARMACY BULK PACKAGE in 1 BOX (50419-188-11) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2010-12-14 2022-05-30 No No Current 50419-188-15 50419018815 20 CARTON in 1 BOX (50419-188-15) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-DOSE 20 carton 2014-06-11 2022-07-31 No No Current 50419-188-36 50419018836 5 SYRINGE in 1 BOX (50419-188-36) > 10 mL in 1 SYRINGE 5 syringe 2014-06-11 2022-02-28 No No Current 50419-188-37 50419018837 5 SYRINGE in 1 BOX (50419-188-37) > 15 mL in 1 SYRINGE 5 syringe 2014-06-11 2023-01-31 No No Current 50419-188-38 50419018838 5 SYRINGE in 1 BOX (50419-188-38) > 20 mL in 1 SYRINGE 5 syringe 2014-06-11 2022-10-30 No No Current 50419-188-40 50419018840 20 CARTON in 1 BOX (50419-188-40) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE 20 carton 2014-06-11 2022-07-31 No No Current 50419-188-42 50419018842 20 CARTON in 1 BOX (50419-188-42) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE 20 carton 2014-06-11 2022-01-31 No No Current 50419-188-43 50419018843 5 SYRINGE in 1 BOX (50419-188-43) > 10 mL in 1 SYRINGE 5 syringe 2014-06-11 2022-02-28 No No Current 50419-188-44 50419018844 20 CARTON in 1 BOX (50419-188-44) > 20 VIAL, SINGLE-DOSE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-DOSE 20 carton 2014-06-11 2022-07-31 No No Current 50419-188-45 50419018845 5 SYRINGE in 1 BOX (50419-188-45) > 15 mL in 1 SYRINGE 5 syringe 2014-06-11 2023-01-31 No No Current 50419-188-46 50419018846 20 CARTON in 1 BOX (50419-188-46) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 20 mL in 1 VIAL, SINGLE-DOSE 20 carton 2014-06-11 2022-01-31 No No Current 50419-188-47 50419018847 5 SYRINGE in 1 BOX (50419-188-47) > 20 mL in 1 SYRINGE 5 syringe 2014-06-11 2022-10-30 No No Current 50419-188-58 50419018858 10 VIAL, PHARMACY BULK PACKAGE in 1 BOX (50419-188-58) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 2010-12-14 2022-05-30 No No Current 50419-188-81 50419018881 2 CARTON in 1 BOX (50419-188-81) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE 2 carton 2016-06-01 2022-07-31 No No Current 50419-188-82 50419018882 2 CARTON in 1 BOX (50419-188-82) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE 2 carton 2016-06-01 2022-01-31 No No Current 50419-188-83 50419018883 2 CARTON in 1 BOX (50419-188-83) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-DOSE 2 carton 2016-06-01 2022-07-31 No No Current 50419-188-84 50419018884 2 CARTON in 1 BOX (50419-188-84) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 20 mL in 1 VIAL, SINGLE-DOSE 2 carton 2016-06-01 2022-01-31 No No Current