Home NDC 50419-324 Ambelvist
Product NDC 50419-324
11-digit product format 504190324
Labeler code 50419
Product ID 50419-324_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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219627-001 AMBELVIST GADOQUATRANE 0.5158GM/2ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 N219627-002 AMBELVIST GADOQUATRANE 1.93425GM/7.5ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 N219627-003 AMBELVIST GADOQUATRANE 2.579GM/10ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 N219627-004 AMBELVIST GADOQUATRANE 3.8685GM/15ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 N219627-005 AMBELVIST GADOQUATRANE 7.737GM/30ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 N219627-006 AMBELVIST GADOQUATRANE 16.7635GM/65ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12
Orange Book patents# Current patent rows page 1 of 1 · 36 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219627-001 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-001 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-001 11491245 2036-05-30 Drug substance 2026-07-10 N219627-001 12478696 2036-05-30 Drug substance 2026-07-10 N219627-001 12303573 2039-11-21 Drug product 2026-07-10 N219627-001 11944690 2040-05-19 Drug product 2026-07-10 N219627-002 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-002 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-002 11491245 2036-05-30 Drug substance 2026-07-10 N219627-002 12478696 2036-05-30 Drug substance 2026-07-10 N219627-002 12303573 2039-11-21 Drug product 2026-07-10 N219627-002 11944690 2040-05-19 Drug product 2026-07-10 N219627-003 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-003 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-003 11491245 2036-05-30 Drug substance 2026-07-10 N219627-003 12478696 2036-05-30 Drug substance 2026-07-10 N219627-003 12303573 2039-11-21 Drug product 2026-07-10 N219627-003 11944690 2040-05-19 Drug product 2026-07-10 N219627-004 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-004 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-004 11491245 2036-05-30 Drug substance 2026-07-10 N219627-004 12478696 2036-05-30 Drug substance 2026-07-10 N219627-004 12303573 2039-11-21 Drug product 2026-07-10 N219627-004 11944690 2040-05-19 Drug product 2026-07-10 N219627-005 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-005 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-005 11491245 2036-05-30 Drug substance 2026-07-10 N219627-005 12478696 2036-05-30 Drug substance 2026-07-10 N219627-005 12303573 2039-11-21 Drug product 2026-07-10 N219627-005 11944690 2040-05-19 Drug product 2026-07-10 N219627-006 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-006 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 N219627-006 11491245 2036-05-30 Drug substance 2026-07-10 N219627-006 12478696 2036-05-30 Drug substance 2026-07-10 N219627-006 12303573 2039-11-21 Drug product 2026-07-10 N219627-006 11944690 2040-05-19 Drug product 2026-07-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N219627-001 AMBELVIST 0.5158GM/2ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-002 AMBELVIST 1.93425GM/7.5ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-003 AMBELVIST 2.579GM/10ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-004 AMBELVIST 3.8685GM/15ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-005 AMBELVIST 7.737GM/30ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-006 AMBELVIST 16.7635GM/65ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219627-001 AMBELVIST 0.5158GM/2ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219627-002 AMBELVIST 1.93425GM/7.5ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219627-003 AMBELVIST 2.579GM/10ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219627-004 AMBELVIST 3.8685GM/15ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219627-005 AMBELVIST 7.737GM/30ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219627-006 AMBELVIST 16.7635GM/65ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219627-001 AMBELVIST 0.5158GM/2ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219627-002 AMBELVIST 1.93425GM/7.5ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219627-003 AMBELVIST 2.579GM/10ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219627-004 AMBELVIST 3.8685GM/15ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219627-005 AMBELVIST 7.737GM/30ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219627-006 AMBELVIST 16.7635GM/65ML (257.9MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N219627-001 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-001 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-001 11491245 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-001 12478696 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-001 12303573 2039-11-21 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-001 11944690 2040-05-19 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-002 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-002 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-002 11491245 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-002 12478696 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-002 12303573 2039-11-21 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-002 11944690 2040-05-19 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-003 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-003 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-003 11491245 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-003 12478696 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-003 12303573 2039-11-21 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-003 11944690 2040-05-19 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-004 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-004 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-004 11491245 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-004 12478696 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-004 12303573 2039-11-21 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-004 11944690 2040-05-19 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-005 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-005 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-005 11491245 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-005 12478696 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-005 12303573 2039-11-21 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-005 11944690 2040-05-19 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-006 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-006 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-006 11491245 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-006 12478696 2036-05-30 Drug substance 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-006 12303573 2039-11-21 Drug product 2026-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219627-006 11944690 2040-05-19 Drug product 2026-07-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219627-001 10137209 2036-05-30 U-4424 Drug substance 2026-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219627-001 10722601 2036-05-30 U-4424 Drug substance 2026-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219627-001 11491245 2036-05-30 Drug substance 2026-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219627-001 12478696 2036-05-30 Drug substance 2026-07-10 caaa826d4ba7…
Observed Orange Book exclusivity history# 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 Ingredient Strength GADOQUATRANE 257.9 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OZG7J613HK Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ambelvist GADOQUATRANE Bayer HealthCare Pharmaceuticals Inc. fac80f5d-8d37-4237-bb52-0faef0dd46aa 2025-06-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 219627 application number: NDA219627 ndc (product): 50419-324
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50419-324-11 50419032411 10 VIAL, SINGLE-DOSE in 1 CARTON (50419-324-11) / 15 mL in 1 VIAL, SINGLE-DOSE (50419-324-01) 2026-06-12 No No Current