Home NDC 0270-1111 ProHance
Product NDC 0270-1111
11-digit product format 002701111
Labeler code 0270
Product ID 0270-1111_2124d0de-8f96-6f0d-6c42-7296def2661f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gadoteridol
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler BRACCO DIAGNOSTICS INC
Application NDA020131
Marketing category NDA
Marketing start 1992-11-16
Substance GADOTERIDOL
Active strength 279.3 mg/mL
Pharmacologic classes Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020131-001 PROHANCE GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020131-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020131-001 PROHANCE 279.3MG/ML INJECTABLE / INJECTION RLD, RS 1992-11-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ProHance
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GADOTERIDOL 279.3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0199MV609F Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0270-1111-70 ProHance 50 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, SOLUTION 50 28 0270-1111-70 ProHance 5 in 1 BOX INJECTION, SOLUTION 5 28 0270-1111-85 ProHance 5 in 1 BOX INJECTION, SOLUTION 5 28 0270-1111-85 ProHance 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, SOLUTION 100 28 0270-1111-01 ProHance 5 in 1 BOX INJECTION, SOLUTION 5 24 0270-1111-01 ProHance 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 24 0270-1111-02 ProHance 15 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 15 24 0270-1111-02 ProHance 5 in 1 BOX INJECTION, SOLUTION 5 24 0270-1111-03 ProHance 5 in 1 BOX INJECTION, SOLUTION 5 24 0270-1111-03 ProHance 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 24 0270-1111-04 ProHance 5 in 1 BOX INJECTION, SOLUTION 5 24 0270-1111-04 ProHance 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded gadoteridol ACTIVE INGREDIENT 0199MV609F PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 7 gadoteridol ACTIVE MOIETY 0199MV609F PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 7 calteridol calcium INACTIVE INGREDIENT RPH56VWA1A PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 7 tromethamine INACTIVE INGREDIENT 023C2WHX2V PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 7 gadoteridol ACTIVE INGREDIENT 0199MV609F PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 6 gadoteridol ACTIVE MOIETY 0199MV609F PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 6 calteridol calcium INACTIVE INGREDIENT RPH56VWA1A PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 6 tromethamine INACTIVE INGREDIENT 023C2WHX2V PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0270-1111 PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 28 Current NDC, Legacy NDC, 4 package rows 20250321_e8b76200-c0aa-491b-aad7-e22d2f68496f.zip 0270-1111 PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 24 Current NDC, Legacy NDC, 8 package rows 20250321_778aee03-7d4c-481a-be8a-a75db0702f5a.zip
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 Marketing end Sample Exclude flag Status 0270-1111-01 00270111101 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-01) / 10 mL in 1 VIAL, SINGLE-DOSE 1992-11-16 0000-00-00 No No Current 0270-1111-02 00270111102 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-02) / 15 mL in 1 VIAL, SINGLE-DOSE 1992-11-16 0000-00-00 No No Current 0270-1111-03 00270111103 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-03) / 20 mL in 1 VIAL, SINGLE-DOSE 1992-11-16 0000-00-00 No No Current 0270-1111-04 00270111104 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-04) / 5 mL in 1 VIAL, SINGLE-DOSE 1992-11-16 0000-00-00 No No Current 0270-1111-16 00270111116 5 SYRINGE, GLASS in 1 BOX (0270-1111-16) > 10 mL in 1 SYRINGE, GLASS 1992-11-16 2023-05-31 No No Current 0270-1111-45 00270111145 5 SYRINGE, GLASS in 1 BOX (0270-1111-45) > 17 mL in 1 SYRINGE, GLASS 1992-11-16 0000-00-00 No No Current 0270-1111-70 00270111170 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 2003-10-09 0000-00-00 No No Current 0270-1111-85 00270111185 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-85) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2022-02-01 0000-00-00 No No Current