Magnevist

Product NDC: 50419-188
Requested package NDC: 50419-188-11
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

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50419-188	50419-188-11	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-188-01	ML - Milliliter	50419-188	682363c2-7c43-48c8-91e7-fb9a72c27f87	1	2012-07-24
50419-188-02	ML - Milliliter	50419-188	62685f87-3b33-4ef1-8e99-53fb9696eb4e	1	2012-07-24
50419-188-05	ML - Milliliter	50419-188	d03df8a3-30fc-4f62-ab23-3295935ad75e	1	2012-07-24
50419-188-11	ML - Milliliter	50419-188	be1625a5-a171-4222-98eb-138e010c2e5f	1	2012-07-24
50419-188-15	ML - Milliliter	50419-188	0c33cdc5-db7a-4609-87ef-0ccb3d80773c	1	2012-07-24
50419-188-36	ML - Milliliter	50419-188	1499c965-3142-492d-b9d8-cbac5fc67318	1	2012-07-24
50419-188-37	ML - Milliliter	50419-188	42445aad-09dd-4bd9-ac80-cd06a7c7d326	1	2012-07-24
50419-188-38	ML - Milliliter	50419-188	9c2322cd-09af-44a1-bb73-be9360b61968	1	2012-07-24
50419-188-44	ML - Milliliter	50419-188	1db23299-476d-41a9-9bb7-b5790f881106	1	2015-07-20
50419-188-47	ML - Milliliter	50419-188	f5a42370-0ed0-4dd2-acd9-36597ba57fa8	1	2012-07-24
50419-188-58	ML - Milliliter	50419-188	1df490be-14b6-4c4a-a9b9-037a819dde82	1	2012-07-24
50419-188-81	ML - Milliliter	50419-188	6ee0e0b1-6706-44bf-9ca2-1590db2d561d	1	2017-04-05
50419-188-82	ML - Milliliter	50419-188	d92ea7e5-4bdd-4da6-b4b3-1fbcafdf0c79	1	2017-04-05
50419-188-83	ML - Milliliter	50419-188	6a83a07f-16a9-4fe5-839e-6f2222976578	1	2017-04-05
50419-188-84	ML - Milliliter	50419-188	dc933313-00e7-47ae-b0ef-a9e9585465ae	1	2017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GADOPENTETATE DIMEGLUMINE	ACTIVE INGREDIENT	RH248G8V27	MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	10
GADOPENTETATE	ACTIVE MOIETY	V7OK6J19HQ	MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	10
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	10
PENTETIC ACID	INACTIVE INGREDIENT	7A314HQM0I	MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	10
GADOPENTETATE DIMEGLUMINE	ACTIVE INGREDIENT	RH248G8V27	MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
GADOPENTETATE	ACTIVE MOIETY	V7OK6J19HQ	MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
PENTETIC ACID	INACTIVE INGREDIENT	7A314HQM0I	MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RH248G8V27	GADOPENTETATE DIMEGLUMINE	86050-77-3	GADOPENTETATE DIMEGLUMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Magnevist	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG	2019-07-23	HUMAN PRESCRIPTION DRUG LABEL	17
Magnevist	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG	2019-07-23	HUMAN PRESCRIPTION DRUG LABEL	12