Home NDC 42337-007 gadobutrol
Product NDC 42337-007
11-digit product format 423370007
Labeler code 42337
Product ID 42337-007_57452c1c-7ad5-1e99-e063-6394a90aa2c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gadobutrol
Dosage form INJECTION
Route INTRAVENOUS
Labeler Viwit Pharmaceutical Co., Ltd.
Application ANDA219287
Marketing category ANDA
Marketing start 2026-06-11
Substance GADOBUTROL
Active strength 604.72 mg/mL
Pharmacologic classes Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219287-001 GADOBUTROL GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 A219287-002 GADOBUTROL GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 A219287-003 GADOBUTROL GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 A219287-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219287-002 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219287-003 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219287-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219287-002 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219287-003 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219287-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219287-002 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219287-003 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2026-06-11 a50c72e98297…
Observed Orange Book normalized TE 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 gadobutrol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GADOBUTROL 604.72 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1BJ477IO2L 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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42337-007-02 42337000702 10 VIAL, SINGLE-DOSE in 1 CARTON (42337-007-02) / 15 mL in 1 VIAL, SINGLE-DOSE (42337-007-01) 2026-06-11 No No Current