Home NDC 52670-556 Choline C 11
Product NDC 52670-556
11-digit product format 526700556
Labeler code 52670
Product ID 52670-556_46dfe43b-1bd0-57a8-e063-6294a90a4c40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Choline C-11
Dosage form INJECTION
Route INTRAVENOUS
Labeler Mayo Clinic
Application NDA203155
Marketing category NDA
Marketing start 2012-09-12
Substance CHOLINE C-11
Active strength 33.1 mCi/mL
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
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 N203155-001 CHOLINE C-11 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N203155-001 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 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203155-001 CHOLINE C-11 4-33.1mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2012-09-12 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 Choline C 11
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHOLINE C-11 33.1 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M4AS4XGD4Q 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 52670-556-30 Choline C 11 30 mL in 1 VIAL INJECTION 30 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52670-556 CHOLINE C 11 (CHOLINE C-11) INJECTION [MAYO CLINIC] 9 Current NDC, Legacy NDC, 1 package rows 20241219_8e046642-5038-4094-b1bb-a1915558fb1c.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 52670-556-30 52670055630 30 mL in 1 VIAL (52670-556-30) 30 ml 2012-09-12 0000-00-00 No No Current