Home NDC 17156-067 Vizamyl
Product NDC 17156-067
11-digit product format 171560067
Labeler code 17156
Product ID 17156-067_4fda8ebc-b46e-4d12-9c45-8cbb3a2516bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flutemetamol F-18
Dosage form SOLUTION
Route INTRAVENOUS
Labeler GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)
Application NDA203137
Marketing category NDA
Marketing start 2014-01-01
Substance FLUTEMETAMOL F-18
Active strength 4.05 mCi/mL
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203137-001 VIZAMYL FLUTEMETAMOL F-18 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 N203137-002 VIZAMYL FLUTEMETAMOL F-18 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203137-001 8916131 2028-09-16 Drug product 2015-02-18 N203137-002 8916131 2028-09-16 Drug product 2015-02-18
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 3 · 84 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 2026-08-18 06:07:40 2026-07 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203137-001 VIZAMYL 40.5mCi/10ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD 2013-10-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203137-002 VIZAMYL 121.5mCi/30ML (4.05mCi/ML) INJECTABLE / INTRAVENOUS RLD, RS 2013-10-25 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 9 · 328 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N203137-001 8916131 2028-09-16 Drug product 2015-02-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203137-002 8916131 2028-09-16 Drug product 2015-02-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203137-001 8916131 2028-09-16 Drug product 2015-02-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203137-002 8916131 2028-09-16 Drug product 2015-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203137-001 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203137-001 8916131 2028-09-16 Drug product 2015-02-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203137-002 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203137-002 8916131 2028-09-16 Drug product 2015-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203137-001 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203137-001 8916131 2028-09-16 Drug product 2015-02-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203137-002 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203137-002 8916131 2028-09-16 Drug product 2015-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203137-001 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203137-001 8916131 2028-09-16 Drug product 2015-02-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203137-002 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203137-002 8916131 2028-09-16 Drug product 2015-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203137-001 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203137-001 8916131 2028-09-16 Drug product 2015-02-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203137-002 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203137-002 8916131 2028-09-16 Drug product 2015-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203137-001 8236282 2024-05-21 Drug substance, Drug product 2013-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203137-001 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203137-001 8916131 2028-09-16 Drug product 2015-02-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203137-002 8236282 2024-05-21 Drug substance, Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203137-002 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203137-002 8916131 2028-09-16 Drug product 2015-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203137-001 8236282 2024-05-21 Drug substance, Drug product 2013-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203137-001 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203137-001 8916131 2028-09-16 Drug product 2015-02-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203137-002 8236282 2024-05-21 Drug substance, Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203137-002 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203137-002 8916131 2028-09-16 Drug product 2015-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203137-001 8236282 2024-05-21 Drug substance, Drug product 2013-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203137-001 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203137-001 8916131 2028-09-16 Drug product 2015-02-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203137-002 8236282 2024-05-21 Drug substance, Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203137-002 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203137-002 8916131 2028-09-16 Drug product 2015-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203137-001 8236282 2024-05-21 Drug substance, Drug product 2013-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203137-001 7270800 2025-09-03 U-336 Drug substance, Drug product 2014-03-28 d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base Vizamyl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUTEMETAMOL F-18 4.05 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L49M066S0O 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 17156-067-10 Vizamyl 1 in 1 CONTAINER SOLUTION 1 31 17156-067-10 Vizamyl 10 mL in 1 VIAL, MULTI-DOSE SOLUTION 10 31 17156-067-30 Vizamyl 1 in 1 CONTAINER SOLUTION 1 31 17156-067-30 Vizamyl 30 mL in 1 VIAL, MULTI-DOSE SOLUTION 30 31
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17156-067 VIZAMYL (FLUTEMETAMOL F-18) SOLUTION [MEDI-PHYSICS, INC. DBA GE HEALTHCARE] 18 Current NDC, Legacy NDC, 4 package rows 20250514_b3558f16-8f9a-4e55-8d9c-836427ebaa57.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vizamyl FLUTEMETAMOL F-18 GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare) b3558f16-8f9a-4e55-8d9c-836427ebaa57 2026-04-06 Warnings, Adverse reactions Exact identifier application applno (NDA): 203137 application number: NDA203137 ndc (product): 17156-067
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 17156-067-10 17156006710 1 in 1 CONTAINER Historical 17156-067-30 17156006730 1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE 2014-03-01 0000-00-00 No No Current