FDA.reportPublic FDA data

gadobutrol

Product NDC
70710-2064
Requested package NDC
70710-2064-6
11-digit product format
707102064
Labeler code
70710
Product ID
70710-2064_4bdf7135-c236-4892-96e0-db2d78d53853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadobutrol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA219287
Marketing category
ANDA
Marketing start
2026-07-14
Substance
GADOBUTROL
Active strength
604.72 mg/mL
Pharmacologic classes
Gadolinium-based Contrast Agent [EPC]; Magnetic Resonance Contrast Activity [MoA]
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219287-001GADOBUTROLGADOBUTROL4.5354GM/7.5ML (604.72MG/ML)SOLUTION / INTRAVENOUSAP2026-06-11
A219287-002GADOBUTROLGADOBUTROL6.0472GM/10ML (604.72MG/ML)SOLUTION / INTRAVENOUSAP2026-06-11
A219287-003GADOBUTROLGADOBUTROL9.0708GM/15ML (604.72MG/ML)SOLUTION / INTRAVENOUSAP2026-06-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A219287-001AP
A219287-002AP
A219287-003AP

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219287-001GADOBUTROL4.5354GM/7.5ML (604.72MG/ML)SOLUTION / INTRAVENOUSAP2026-06-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219287-002GADOBUTROL6.0472GM/10ML (604.72MG/ML)SOLUTION / INTRAVENOUSAP2026-06-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219287-003GADOBUTROL9.0708GM/15ML (604.72MG/ML)SOLUTION / INTRAVENOUSAP2026-06-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219287-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219287-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219287-003AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADOBUTROL604.72 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1BJ477IO2LInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ea8ae43-22ca-40c0-be72-c91a321cafd1Available 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gadobutrolGADOBUTROLZydus Pharmaceuticals USA Inc.4ea8ae43-22ca-40c0-be72-c91a321cafd12026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219287
application number: ANDA219287
ndc (package): 70710-2064-6
ndc (product): 70710-2064
ndc11 (package): 70710206406
gadobutrolGADOBUTROLViwit Pharmaceutical Co., Ltd.18c67a70-0c1f-46d4-a123-66080090b71b2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219287
application number: ANDA219287

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
70710-2064-67071020640610 VIAL, SINGLE-DOSE in 1 CARTON (70710-2064-6) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70710-2064-1)2026-07-140Current