FDA.reportPublic FDA data

DOTAREM

Product NDC
67684-2000
11-digit product format
676842000
Labeler code
67684
Product ID
67684-2000_313093fe-89fb-4ca8-973c-f36175bb47df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadoterate meglumine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Guerbet LLC
Application
NDA204781
Marketing category
NDA
Marketing start
2013-03-20
Substance
GADOTERATE MEGLUMINE
Active strength
376.9 mg/mL
Pharmacologic classes
Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67684-200067684-2000-5DDiscontinued by firm2026-08-17
excluded packagepackage67684-200067684-2000-6DDiscontinued by firm2026-08-17
excluded packagepackage67684-200067684-2000-7DDiscontinued by firm2026-08-17

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, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0567684-2000-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0567684-2000-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0567684-2000-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2667684-2000-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2667684-2000-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2667684-2000-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3167684-2000-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3167684-2000-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3167684-2000-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2867684-2000-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2867684-2000-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2867684-2000-5a1b67e2a42f9…c4cf2c586c0d…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204781-001DOTAREMGADOTERATE MEGLUMINE37.69GM/100ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20
N204781-002DOTAREMGADOTERATE MEGLUMINE3.769GM/10ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20
N204781-003DOTAREMGADOTERATE MEGLUMINE5.6535GM/15ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20
N204781-004DOTAREMGADOTERATE MEGLUMINE7.538GM/20ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20
N204781-005DOTAREMGADOTERATE MEGLUMINE1.8845GM/5ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2017-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N204781-001AP
N204781-002AP
N204781-003AP
N204781-004AP
N204781-005AP

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N204781-001DOTAREM37.69GM/100ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20caaa826d4ba7…
2026-08-18 06:07:402026-07N204781-002DOTAREM3.769GM/10ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20caaa826d4ba7…
2026-08-18 06:07:402026-07N204781-003DOTAREM5.6535GM/15ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20caaa826d4ba7…
2026-08-18 06:07:402026-07N204781-004DOTAREM7.538GM/20ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20caaa826d4ba7…
2026-08-18 06:07:402026-07N204781-005DOTAREM1.8845GM/5ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2017-03-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204781-001DOTAREM37.69GM/100ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204781-002DOTAREM3.769GM/10ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204781-003DOTAREM5.6535GM/15ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204781-004DOTAREM7.538GM/20ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204781-005DOTAREM1.8845GM/5ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2017-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204781-001DOTAREM37.69GM/100ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204781-002DOTAREM3.769GM/10ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204781-003DOTAREM5.6535GM/15ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204781-004DOTAREM7.538GM/20ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204781-005DOTAREM1.8845GM/5ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2017-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N204781-001DOTAREM37.69GM/100ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204781-002DOTAREM3.769GM/10ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204781-003DOTAREM5.6535GM/15ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204781-004DOTAREM7.538GM/20ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204781-005DOTAREM1.8845GM/5ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2017-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204781-001DOTAREM37.69GM/100ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204781-002DOTAREM3.769GM/10ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204781-003DOTAREM5.6535GM/15ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204781-004DOTAREM7.538GM/20ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204781-005DOTAREM1.8845GM/5ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2017-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204781-001DOTAREM37.69GM/100ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204781-002DOTAREM3.769GM/10ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204781-003DOTAREM5.6535GM/15ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204781-004DOTAREM7.538GM/20ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204781-005DOTAREM1.8845GM/5ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2017-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204781-001DOTAREM37.69GM/100ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204781-002DOTAREM3.769GM/10ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204781-003DOTAREM5.6535GM/15ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204781-004DOTAREM7.538GM/20ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204781-005DOTAREM1.8845GM/5ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2017-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204781-001DOTAREM37.69GM/100ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204781-002DOTAREM3.769GM/10ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204781-003DOTAREM5.6535GM/15ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204781-004DOTAREM7.538GM/20ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204781-005DOTAREM1.8845GM/5ML (376.9MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2017-03-312680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 195 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N204781-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N204781-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N204781-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N204781-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N204781-005AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204781-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204781-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204781-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204781-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204781-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204781-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204781-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204781-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204781-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204781-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N204781-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204781-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204781-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204781-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204781-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204781-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204781-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204781-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204781-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204781-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204781-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204781-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204781-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204781-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204781-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204781-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204781-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204781-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204781-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204781-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204781-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204781-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204781-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204781-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204781-005AP12680178bc6a6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N204781-001NPP2020-08-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204781-002NPP2020-08-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204781-003NPP2020-08-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204781-004NPP2020-08-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204781-005NPP2020-08-2574a2ff9319b5…
2020-12-22 03:56 UTC2020-12N204781-001NPP2020-08-258869cabd3fbd…
2020-12-22 03:56 UTC2020-12N204781-002NPP2020-08-258869cabd3fbd…
2020-12-22 03:56 UTC2020-12N204781-003NPP2020-08-258869cabd3fbd…
2020-12-22 03:56 UTC2020-12N204781-004NPP2020-08-258869cabd3fbd…
2020-12-22 03:56 UTC2020-12N204781-005NPP2020-08-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204781-001NPP2020-08-25c0c555d07b60…
2020-11-12 02:37 UTC2020-11N204781-002NPP2020-08-25c0c555d07b60…
2020-11-12 02:37 UTC2020-11N204781-003NPP2020-08-25c0c555d07b60…
2020-11-12 02:37 UTC2020-11N204781-004NPP2020-08-25c0c555d07b60…
2020-11-12 02:37 UTC2020-11N204781-005NPP2020-08-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204781-001NPP2020-08-253f01610625f2…
2019-12-14 00:12 UTC2019-12N204781-002NPP2020-08-253f01610625f2…
2019-12-14 00:12 UTC2019-12N204781-003NPP2020-08-253f01610625f2…
2019-12-14 00:12 UTC2019-12N204781-004NPP2020-08-253f01610625f2…
2019-12-14 00:12 UTC2019-12N204781-005NPP2020-08-253f01610625f2…
2019-09-15 20:21 UTC2019-09N204781-001NPP2020-08-25b00525d2431f…
2019-09-15 20:21 UTC2019-09N204781-002NPP2020-08-25b00525d2431f…
2019-09-15 20:21 UTC2019-09N204781-003NPP2020-08-25b00525d2431f…
2019-09-15 20:21 UTC2019-09N204781-004NPP2020-08-25b00525d2431f…
2019-09-15 20:21 UTC2019-09N204781-005NPP2020-08-25b00525d2431f…
2019-07-19 19:46 UTC2019-07N204781-001NPP2020-08-25ea99ee380514…
2019-07-19 19:46 UTC2019-07N204781-002NPP2020-08-25ea99ee380514…
2019-07-19 19:46 UTC2019-07N204781-003NPP2020-08-25ea99ee380514…
2019-07-19 19:46 UTC2019-07N204781-004NPP2020-08-25ea99ee380514…
2019-07-19 19:46 UTC2019-07N204781-005NPP2020-08-25ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
DOTAREM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADOTERATE MEGLUMINE376.9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L0ND3981AGInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5b2d15dc-225b-aca9-f9ef-b38666fe1e57Product name420250620
c34d3757-8380-f2a9-d77b-04fccc1c986eProduct name420250226
3c495eba-e7eb-cf97-a376-25ae31b0cc54Product name120140508
51162ac0-9a99-d9a1-b417-523615d04171Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67684-2000-42023-12-28C16284748780-1f386c649-9c83-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOTAREM safely and effectively. See full prescribing information for DOTAREM. DOTAREM ® (gadoterate meglumine) Injection for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013
67684-2000-42023-01-30C16284748780-1f386c649-9c83-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOTAREM safely and effectively. See full prescribing information for DOTAREM. DOTAREM ® (gadoterate meglumine) Injection for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67684-2000-0DOTAREM10 in 1 PACKAGEINJECTION1025
67684-2000-0DOTAREM5 mL in 1 VIALINJECTION525
67684-2000-1DOTAREM10 mL in 1 VIALINJECTION1025
67684-2000-1DOTAREM10 in 1 PACKAGEINJECTION1025
67684-2000-2DOTAREM10 in 1 PACKAGEINJECTION1025
67684-2000-2DOTAREM15 mL in 1 VIALINJECTION1525
67684-2000-3DOTAREM20 mL in 1 VIALINJECTION2025
67684-2000-3DOTAREM10 in 1 PACKAGEINJECTION1025
67684-2000-5DOTAREM5 in 1 PACKAGEINJECTION525
67684-2000-5DOTAREM10 mL in 1 SYRINGEINJECTION1025
67684-2000-6DOTAREM15 mL in 1 SYRINGEINJECTION1525
67684-2000-6DOTAREM5 in 1 PACKAGEINJECTION525
67684-2000-7DOTAREM20 mL in 1 SYRINGEINJECTION2025
67684-2000-7DOTAREM5 in 1 PACKAGEINJECTION525
67684-2000-4DOTAREM6 in 1 PACKAGEInjection617
67684-2000-4DOTAREM100 mL in 1 VIALInjection10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67684-2000-0ML - Milliliter67684-200037f15795-d63f-460a-9206-c5c0da62856412019-01-24
67684-2000-1ML - Milliliter67684-20003016fd32-3e7d-4b63-ba2c-b9a9e3d6d79f12013-09-04
67684-2000-2ML - Milliliter67684-2000d47ebf69-7683-4f57-9b86-2abf8caf6d7212013-09-04
67684-2000-3ML - Milliliter67684-2000b3ecd5e5-11e1-43da-876e-5c5f327e2b0912013-09-04
67684-2000-4ML - Milliliter67684-20006b70e2f1-b672-4e34-82fa-30c23d0c3eca12013-09-04
67684-2000-5ML - Milliliter67684-20002664bf82-741c-4f1e-b761-f9d56049b77f12013-10-17
67684-2000-6ML - Milliliter67684-20003c7eb227-6a12-449b-ae4c-9919aa3b918712013-10-17
67684-2000-7ML - Milliliter67684-2000a6a6a298-2b05-46fe-8f1d-a7f06160918e12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gadoterate meglumineACTIVE INGREDIENTL0ND3981AGDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]3
GADOLINIUM CATION (3+)ACTIVE MOIETYAZV954TZ9NDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]3
gadoterate meglumineACTIVE INGREDIENTL0ND3981AGDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]2
GADOLINIUM CATION (3+)ACTIVE MOIETYAZV954TZ9NDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67684-2000DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]25Current NDC, Legacy NDC, 14 package rows20250321_e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc.zip
67684-2000DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]17Current NDC, Legacy NDC, 2 package rows20250321_82b83e61-6af8-4225-aa39-8cbf206f65b0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOTAREMGADOTERATE MEGLUMINEGuerbet LLCe2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc2025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 204781
application number: NDA204781
ndc (product): 67684-2000
DOTAREMGADOTERATE MEGLUMINEGuerbet LLC82b83e61-6af8-4225-aa39-8cbf206f65b02025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 204781
application number: NDA204781
ndc (product): 67684-2000

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67684-2000-06768420000010 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL10 vial2017-03-310000-00-00NoNoCurrent
67684-2000-16768420000110 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL10 vial2013-03-200000-00-00NoNoCurrent
67684-2000-26768420000210 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL10 vial2013-03-200000-00-00NoNoCurrent
67684-2000-36768420000310 VIAL in 1 PACKAGE (67684-2000-3) / 20 mL in 1 VIAL10 vial2013-03-200000-00-00NoNoCurrent
67684-2000-4676842000046 VIAL in 1 PACKAGE (67684-2000-4) / 100 mL in 1 VIAL6 vial2013-04-260000-00-00NoNoCurrent
67684-2000-5676842000055 SYRINGE in 1 PACKAGE (67684-2000-5) > 10 mL in 1 SYRINGE5 syringe2013-03-200000-00-00NoNoCurrent
67684-2000-6676842000065 SYRINGE in 1 PACKAGE (67684-2000-6) > 15 mL in 1 SYRINGE5 syringe2013-03-200000-00-00NoNoCurrent
67684-2000-7676842000075 SYRINGE in 1 PACKAGE (67684-2000-7) > 20 mL in 1 SYRINGE5 syringe2013-03-200000-00-00NoNoCurrent