Ambelvist

Product NDC
50419-331
Requested package NDC
50419-331-11
11-digit product format
504190331
Labeler code
50419
Product ID
50419-331_7c4d8f12-64e0-465f-9b4b-99700e141feb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gadoquatrane
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA219627
Marketing category
NDA
Marketing start
2026-06-12
Substance
GADOQUATRANE
Active strength
257.9 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219627-001AMBELVISTGADOQUATRANE0.5158GM/2ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12
N219627-002AMBELVISTGADOQUATRANE1.93425GM/7.5ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12
N219627-003AMBELVISTGADOQUATRANE2.579GM/10ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12
N219627-004AMBELVISTGADOQUATRANE3.8685GM/15ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12
N219627-005AMBELVISTGADOQUATRANE7.737GM/30ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12
N219627-006AMBELVISTGADOQUATRANE16.7635GM/65ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219627-001101372092036-05-30U-4424Drug substance2026-07-10
N219627-001107226012036-05-30U-4424Drug substance2026-07-10
N219627-001114912452036-05-30Drug substance2026-07-10
N219627-001124786962036-05-30Drug substance2026-07-10
N219627-001123035732039-11-21Drug product2026-07-10
N219627-001119446902040-05-19Drug product2026-07-10
N219627-002101372092036-05-30U-4424Drug substance2026-07-10
N219627-002107226012036-05-30U-4424Drug substance2026-07-10
N219627-002114912452036-05-30Drug substance2026-07-10
N219627-002124786962036-05-30Drug substance2026-07-10
N219627-002123035732039-11-21Drug product2026-07-10
N219627-002119446902040-05-19Drug product2026-07-10
N219627-003101372092036-05-30U-4424Drug substance2026-07-10
N219627-003107226012036-05-30U-4424Drug substance2026-07-10
N219627-003114912452036-05-30Drug substance2026-07-10
N219627-003124786962036-05-30Drug substance2026-07-10
N219627-003123035732039-11-21Drug product2026-07-10
N219627-003119446902040-05-19Drug product2026-07-10
N219627-004101372092036-05-30U-4424Drug substance2026-07-10
N219627-004107226012036-05-30U-4424Drug substance2026-07-10
N219627-004114912452036-05-30Drug substance2026-07-10
N219627-004124786962036-05-30Drug substance2026-07-10
N219627-004123035732039-11-21Drug product2026-07-10
N219627-004119446902040-05-19Drug product2026-07-10
N219627-005101372092036-05-30U-4424Drug substance2026-07-10
N219627-005107226012036-05-30U-4424Drug substance2026-07-10
N219627-005114912452036-05-30Drug substance2026-07-10
N219627-005124786962036-05-30Drug substance2026-07-10
N219627-005123035732039-11-21Drug product2026-07-10
N219627-005119446902040-05-19Drug product2026-07-10
N219627-006101372092036-05-30U-4424Drug substance2026-07-10
N219627-006107226012036-05-30U-4424Drug substance2026-07-10
N219627-006114912452036-05-30Drug substance2026-07-10
N219627-006124786962036-05-30Drug substance2026-07-10
N219627-006123035732039-11-21Drug product2026-07-10
N219627-006119446902040-05-19Drug product2026-07-10

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219627-001NCE2031-06-12
N219627-002NCE2031-06-12
N219627-003NCE2031-06-12
N219627-004NCE2031-06-12
N219627-005NCE2031-06-12
N219627-006NCE2031-06-12

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N219627-001AMBELVIST0.5158GM/2ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N219627-002AMBELVIST1.93425GM/7.5ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N219627-003AMBELVIST2.579GM/10ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N219627-004AMBELVIST3.8685GM/15ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N219627-005AMBELVIST7.737GM/30ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N219627-006AMBELVIST16.7635GM/65ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-1284e616aacf4f…
2026-08-18 06:07:402026-07N219627-001AMBELVIST0.5158GM/2ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-002AMBELVIST1.93425GM/7.5ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-003AMBELVIST2.579GM/10ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-004AMBELVIST3.8685GM/15ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-005AMBELVIST7.737GM/30ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-006AMBELVIST16.7635GM/65ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-001AMBELVIST0.5158GM/2ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-002AMBELVIST1.93425GM/7.5ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-003AMBELVIST2.579GM/10ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-004AMBELVIST3.8685GM/15ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-005AMBELVIST7.737GM/30ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-006AMBELVIST16.7635GM/65ML (257.9MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-12a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219627-001101372092036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-001107226012036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-001114912452036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-001124786962036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-001123035732039-11-21Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-001119446902040-05-19Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-002101372092036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-002107226012036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-002114912452036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-002124786962036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-002123035732039-11-21Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-002119446902040-05-19Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-003101372092036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-003107226012036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-003114912452036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-003124786962036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-003123035732039-11-21Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-003119446902040-05-19Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-004101372092036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-004107226012036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-004114912452036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-004124786962036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-004123035732039-11-21Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-004119446902040-05-19Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-005101372092036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-005107226012036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-005114912452036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-005124786962036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-005123035732039-11-21Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-005119446902040-05-19Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-006101372092036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-006107226012036-05-30U-4424Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-006114912452036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-006124786962036-05-30Drug substance2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-006123035732039-11-21Drug product2026-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N219627-006119446902040-05-19Drug product2026-07-1084e616aacf4f…
2026-08-18 06:07:402026-07N219627-001101372092036-05-30U-4424Drug substance2026-07-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-001107226012036-05-30U-4424Drug substance2026-07-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-001114912452036-05-30Drug substance2026-07-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-001124786962036-05-30Drug substance2026-07-10caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219627-001NCE2031-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N219627-002NCE2031-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N219627-003NCE2031-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N219627-004NCE2031-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N219627-005NCE2031-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N219627-006NCE2031-06-1284e616aacf4f…
2026-08-18 06:07:402026-07N219627-001NCE2031-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-002NCE2031-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-003NCE2031-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-004NCE2031-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-005NCE2031-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N219627-006NCE2031-06-12caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-001NCE2031-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-002NCE2031-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-003NCE2031-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-004NCE2031-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-005NCE2031-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219627-006NCE2031-06-12a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ambelvist
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADOQUATRANE257.9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OZG7J613HKInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fac80f5d-8d37-4237-bb52-0faef0dd46aaAvailable on FDA.report

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmbelvistGADOQUATRANEBayer HealthCare Pharmaceuticals Inc.fac80f5d-8d37-4237-bb52-0faef0dd46aa2025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 219627
application number: NDA219627
ndc (package): 50419-331-11
ndc (product): 50419-331
ndc11 (package): 50419033111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50419-331-11504190331115 SYRINGE in 1 CARTON (50419-331-11) / 10 mL in 1 SYRINGE (50419-331-01) 5 syringe2026-06-12NoNoCurrent