Home DailyMed 56bd2db9-dd1d-41f9-b5af-5bed59ea9a3b National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:50:25 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 N201277-001 GADAVIST GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 N201277-002 GADAVIST GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 N201277-003 GADAVIST GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 N201277-004 GADAVIST GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 N201277-005 GADAVIST GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 N201277-006 GADAVIST GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-12-18
Therapeutic equivalence codes# Current TE-code 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.
Product history page 1 of 7 · 258 observed 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 N201277-001 GADAVIST 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201277-002 GADAVIST 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201277-003 GADAVIST 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201277-004 GADAVIST 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201277-005 GADAVIST 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201277-006 GADAVIST 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-12-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201277-001 GADAVIST 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201277-002 GADAVIST 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201277-003 GADAVIST 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201277-004 GADAVIST 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201277-005 GADAVIST 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201277-006 GADAVIST 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201277-001 GADAVIST 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201277-002 GADAVIST 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201277-003 GADAVIST 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201277-004 GADAVIST 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201277-005 GADAVIST 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201277-006 GADAVIST 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201277-001 GADAVIST 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201277-002 GADAVIST 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201277-003 GADAVIST 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201277-004 GADAVIST 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201277-005 GADAVIST 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201277-006 GADAVIST 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201277-001 GADAVIST 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201277-002 GADAVIST 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201277-003 GADAVIST 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201277-004 GADAVIST 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201277-005 GADAVIST 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201277-006 GADAVIST 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201277-001 GADAVIST 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201277-002 GADAVIST 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201277-003 GADAVIST 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201277-004 GADAVIST 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201277-005 GADAVIST 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201277-006 GADAVIST 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201277-001 GADAVIST 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201277-002 GADAVIST 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201277-003 GADAVIST 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201277-004 GADAVIST 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-03-14 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 148 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N201277-006 5980864 2021-11-09 U-1119 Drug substance, Drug product 2016-03-17 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N201277-006 5980864 2021-11-09 U-1119 Drug substance, Drug product 2016-03-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201277-006 5980864 2021-11-09 U-1119 Drug substance, Drug product 2016-03-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201277-006 5980864 2021-11-09 U-1119 Drug substance, Drug product 2016-03-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201277-006 5980864 2021-11-09 U-1119 Drug substance, Drug product 2016-03-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201277-006 5980864 2021-11-09 U-1119 Drug substance, Drug product 2016-03-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201277-006 5980864 2021-11-09 U-1119 Drug substance, Drug product 2016-03-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201277-006 5980864 2021-11-09 U-1119 Drug substance, Drug product 2016-03-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201277-006 5980864 2021-11-09 U-1119 Drug substance, Drug product 2016-03-17 ea99ee380514…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 106 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.