Home NDC 72874-001 CERIANNA
Product NDC 72874-001
11-digit product format 728740001
Labeler code 72874
Product ID 72874-001_fd28ffaf-5b17-43e7-bc91-fd623819340e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUOROESTRADIOL F 18
Dosage form INJECTION
Route INTRAVENOUS
Labeler GE Healthcare Inc.
Application NDA212155
Marketing category NDA
Marketing start 2020-05-20
Substance FLUOROESTRADIOL F-18
Active strength 100 mCi/mL
Pharmacologic classes Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
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 42 .
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 N212155-001 CERIANNA FLUOROESTRADIOL F-18 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212155-001 CERIANNA 50ML (4-100mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-05-20 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base CERIANNA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROESTRADIOL F-18 100 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T32277KB09 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 72874-001-01 CERIANNA 50 mL in 1 VIAL, MULTI-DOSE INJECTION 50 27
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72874-001 CERIANNA (FLUOROESTRADIOL F 18) INJECTION [GE HEALTHCARE INC.] 21 Current NDC, Legacy NDC, 1 package rows 20250126_b2c2a2df-cf3e-4a29-a033-231ed5a94b58.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 72874-001-01 72874000101 50 mL in 1 VIAL, MULTI-DOSE (72874-001-01) 50 ml 2020-05-20 0000-00-00 No No Current