Home NDC 0270-0083 Choletec
Product NDC 0270-0083
11-digit product format 002700083
Labeler code 0270
Product ID 0270-0083_c9c87a8e-a0ca-2d0b-b547-b901932928c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mebrofenin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Bracco Diagnostics Inc
Application NDA018963
Marketing category NDA
Marketing start 1987-01-21
Substance MEBROFENIN
Active strength 45 mg/1
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 N018963-001 CHOLETEC TECHNETIUM TC-99M MEBROFENIN KIT N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018963-001 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 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018963-001 CHOLETEC N/A INJECTABLE / INJECTION AP RLD, RS 1987-01-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Choletec
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEBROFENIN 45 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7PV0B6ED98 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0270-0083-20 Choletec 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 10 0270-0083-20 Choletec 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEBROFENIN ACTIVE INGREDIENT 7PV0B6ED98 CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 6 MEBROFENIN ACTIVE MOIETY 7PV0B6ED98 CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 6 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 6 STANNOUS FLUORIDE INACTIVE INGREDIENT 3FTR44B32Q CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0270-0083 CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC] 9 Current NDC, Legacy NDC, 2 package rows 20240614_fd085485-998d-42a3-879a-b2d96cb8aed7.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0270-0083-20 00270008320 10 VIAL in 1 CARTON (0270-0083-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 10 vial 1987-01-21 0000-00-00 No No Current