Home NDC 69932-002 POSLUMA
Product NDC 69932-002
11-digit product format 699320002
Labeler code 69932
Product ID 69932-002_67cbcafa-00b3-41fd-986d-1159706273f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name flotufolastat F-18
Dosage form INJECTION
Route INTRAVENOUS
Labeler Blue Earth Diagnostics
Application NDA216023
Marketing category NDA
Marketing start 2023-05-25
Substance FLOTUFOLASTAT F-18
Active strength 158 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 43 .
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 N216023-001 POSLUMA FLOTUFOLASTAT F-18 GALLIUM 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216023-001 12390540 2038-08-23 Drug substance 2025-09-03 N216023-001 11413360 2038-11-22 U-3614 Drug substance 2023-06-06 N216023-001 11413360 2038-11-22 U-3615 Drug substance 2023-06-06 N216023-001 12357711 2038-11-22 Drug substance 2025-08-06 N216023-001 12377176 2038-11-22 Drug substance 2025-09-03 N216023-001 12036290 2041-11-27 U-3614 Drug product 2024-08-01 N216023-001 12036290 2041-11-27 U-3615 Drug product 2024-08-01 N216023-001 12427207 2041-11-27 Drug product 2025-10-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216023-001 NCE 2028-05-25
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 2026-09-14 22:38:34 2026-08 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216023-001 POSLUMA 50ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216023-001 POSLUMA 50ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216023-001 POSLUMA 25ML (8-158mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 96 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N216023-001 12390540 2038-08-23 Drug substance 2025-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216023-001 11413360 2038-11-22 U-3614 Drug substance 2023-06-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216023-001 11413360 2038-11-22 U-3615 Drug substance 2023-06-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216023-001 12357711 2038-11-22 Drug substance 2025-08-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216023-001 12377176 2038-11-22 Drug substance 2025-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216023-001 12036290 2041-11-27 U-3614 Drug product 2024-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216023-001 12036290 2041-11-27 U-3615 Drug product 2024-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216023-001 12427207 2041-11-27 Drug product 2025-10-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216023-001 12390540 2038-08-23 Drug substance 2025-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216023-001 11413360 2038-11-22 U-3614 Drug substance 2023-06-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216023-001 11413360 2038-11-22 U-3615 Drug substance 2023-06-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216023-001 12357711 2038-11-22 Drug substance 2025-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216023-001 12377176 2038-11-22 Drug substance 2025-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216023-001 12036290 2041-11-27 U-3614 Drug product 2024-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216023-001 12036290 2041-11-27 U-3615 Drug product 2024-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216023-001 12427207 2041-11-27 Drug product 2025-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216023-001 12390540 2038-08-23 Drug substance 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216023-001 11413360 2038-11-22 U-3614 Drug substance 2023-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216023-001 11413360 2038-11-22 U-3615 Drug substance 2023-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216023-001 12357711 2038-11-22 Drug substance 2025-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216023-001 12377176 2038-11-22 Drug substance 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216023-001 12036290 2041-11-27 U-3614 Drug product 2024-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216023-001 12036290 2041-11-27 U-3615 Drug product 2024-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216023-001 12427207 2041-11-27 Drug product 2025-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216023-001 12390540 2038-08-23 Drug substance 2025-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216023-001 11413360 2038-11-22 U-3614 Drug substance 2023-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216023-001 11413360 2038-11-22 U-3615 Drug substance 2023-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216023-001 12357711 2038-11-22 Drug substance 2025-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216023-001 12377176 2038-11-22 Drug substance 2025-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216023-001 12036290 2041-11-27 U-3614 Drug product 2024-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216023-001 12036290 2041-11-27 U-3615 Drug product 2024-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216023-001 12427207 2041-11-27 Drug product 2025-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216023-001 11413360 2038-11-22 U-3614 Drug substance 2023-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216023-001 11413360 2038-11-22 U-3615 Drug substance 2023-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216023-001 12036290 2041-11-27 U-3614 Drug product 2024-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216023-001 12036290 2041-11-27 U-3615 Drug product 2024-08-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216023-001 11413360 2038-11-22 U-3614 Drug substance 2023-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216023-001 11413360 2038-11-22 U-3615 Drug substance 2023-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216023-001 12036290 2041-11-27 U-3614 Drug product 2024-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216023-001 12036290 2041-11-27 U-3615 Drug product 2024-08-01 fd3edfee7708…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base POSLUMA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLOTUFOLASTAT F-18 158 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 811W19E3OL 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 69932-002-50 POSLUMA 25 mL in 1 VIAL, MULTI-DOSE INJECTION 25 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69932-002 POSLUMA (FLOTUFOLASTAT F-18) INJECTION [BLUE EARTH DIAGNOSTICS] 9 Current NDC, 1 package rows 20250212_907ac4a4-a088-4826-ab50-cfc31985c9d4.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 Sample Exclude flag Status 69932-002-50 69932000250 25 mL in 1 VIAL, MULTI-DOSE (69932-002-50) 25 ml 2023-05-25 No No Current