Pixxoscan

Product NDC: 0407-1066
11-digit product format: 004071066
Labeler code: 0407
Product ID: 0407-1066_5e45495c-0abc-4b5e-ab94-185d9b971d3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GADOBUTROL
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: GE Healthcare Inc.
Application: ANDA215957
Marketing category: ANDA
Marketing start: 2026-09-30
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215957-001	PIXXOSCAN	GADOBUTROL	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29
A215957-002	PIXXOSCAN	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29
A215957-003	PIXXOSCAN	GADOBUTROL	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29
A215957-004	PIXXOSCAN	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A215957-001	AP
A215957-002	AP
A215957-003	AP
A215957-004	AP

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215957-001	PIXXOSCAN	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215957-002	PIXXOSCAN	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215957-003	PIXXOSCAN	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215957-004	PIXXOSCAN	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215957-001	PIXXOSCAN	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215957-002	PIXXOSCAN	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215957-003	PIXXOSCAN	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215957-004	PIXXOSCAN	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215957-001	PIXXOSCAN	1.20944GM/2ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215957-002	PIXXOSCAN	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215957-003	PIXXOSCAN	6.0472GM/10ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215957-004	PIXXOSCAN	9.0708GM/15ML (604.72MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-06-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215957-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215957-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215957-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215957-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215957-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215957-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215957-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215957-004	AP	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215957-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215957-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215957-003	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215957-004	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1BJ477IO2L	GADOBUTROL	770691-21-9	GADOBUTROL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0407-1066-02	00407106602	10 VIAL, GLASS in 1 BOX (0407-1066-02) / 2 mL in 1 VIAL, GLASS	2026-09-30	No	No	Historical
0407-1066-08	00407106608	10 VIAL, GLASS in 1 BOX (0407-1066-08) / 7.5 mL in 1 VIAL, GLASS	2026-09-30	No	No	Historical
0407-1066-10	00407106610	10 VIAL, GLASS in 1 BOX (0407-1066-10) / 10 mL in 1 VIAL, GLASS	2026-09-30	No	No	Historical
0407-1066-15	00407106615	10 VIAL, GLASS in 1 BOX (0407-1066-15) / 15 mL in 1 VIAL, GLASS	2026-09-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pixxoscan	GE Healthcare Inc. \| GE Healthcare AS \| ST Pharm Co., Ltd. \| Quotient Sciences (Alnwick) Limited \| VANAMALI ORGANICS Private Limited \| GE Healthcare AS avd Lindesnes	2026-10-09	HUMAN PRESCRIPTION DRUG LABEL	10