Amyvid

Product NDC
0002-1200
11-digit product format
000021200
Labeler code
0002
Product ID
0002-1200_63e1d0b5-c634-4699-91b2-643a6e765139
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Florbetapir F 18
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eli Lilly and Company
Application
NDA202008
Marketing category
NDA
Marketing start
2012-06-01
Substance
FLORBETAPIR F-18
Active strength
51 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202008-001AMYVIDFLORBETAPIR F-1810ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06
N202008-002AMYVIDFLORBETAPIR F-1810-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06
N202008-003AMYVIDFLORBETAPIR F-1810-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-06
N202008-004AMYVIDFLORBETAPIR F-1810-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-13

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202008-00176870522027-04-30U-4217Drug substance, Drug product2012-05-04
N202008-00185069292027-04-30U-4217Drug substance, Drug product2013-09-06
N202008-00276870522027-04-30U-4217Drug substance, Drug product
N202008-00285069292027-04-30U-4217Drug substance, Drug product
N202008-00376870522027-04-30U-4217Drug substance, Drug product
N202008-00385069292027-04-30U-4217Drug substance, Drug product
N202008-00476870522027-04-30U-4217Drug substance, Drug product2025-07-23
N202008-00485069292027-04-30U-4217Drug substance, Drug product2025-07-23

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 4 · 145 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N202008-001AMYVID10ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07N202008-002AMYVID10-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07N202008-003AMYVID10-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07N202008-004AMYVID10-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202008-001AMYVID10ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202008-002AMYVID10-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202008-003AMYVID10-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202008-004AMYVID10-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-001AMYVID10ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-002AMYVID10-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-003AMYVID10-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-004AMYVID10-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N202008-001AMYVID10ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202008-002AMYVID10-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202008-003AMYVID10-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202008-004AMYVID10-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202008-001AMYVID10ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202008-002AMYVID10-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202008-003AMYVID10-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202008-004AMYVID10-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202008-001AMYVID10ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202008-002AMYVID10-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202008-003AMYVID10-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202008-004AMYVID10-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202008-001AMYVID10ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202008-002AMYVID10-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202008-003AMYVID10-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202008-004AMYVID10-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202008-001AMYVID10ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202008-002AMYVID10-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202008-003AMYVID10-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202008-004AMYVID10-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202008-001AMYVID10ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202008-002AMYVID10-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202008-003AMYVID10-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202008-004AMYVID10-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202008-001AMYVID10ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202008-002AMYVID10-30ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD2012-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202008-003AMYVID10-50ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2012-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202008-004AMYVID10-100ML (13.5-51mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-13d8e5a09893c0…

Observed Orange Book patent history#

Patent history page 1 of 7 · 262 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N202008-00176870522027-04-30U-4217Drug substance, Drug product2012-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07N202008-00185069292027-04-30U-4217Drug substance, Drug product2013-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N202008-00276870522027-04-30U-4217Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N202008-00285069292027-04-30U-4217Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N202008-00376870522027-04-30U-4217Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N202008-00385069292027-04-30U-4217Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N202008-00476870522027-04-30U-4217Drug substance, Drug product2025-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07N202008-00485069292027-04-30U-4217Drug substance, Drug product2025-07-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202008-00176870522027-04-30U-4217Drug substance, Drug product2012-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202008-00185069292027-04-30U-4217Drug substance, Drug product2013-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202008-00276870522027-04-30U-4217Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202008-00285069292027-04-30U-4217Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202008-00376870522027-04-30U-4217Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202008-00385069292027-04-30U-4217Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202008-00476870522027-04-30U-4217Drug substance, Drug product2025-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202008-00485069292027-04-30U-4217Drug substance, Drug product2025-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-00176870522027-04-30U-4217Drug substance, Drug product2012-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-00185069292027-04-30U-4217Drug substance, Drug product2013-09-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-00276870522027-04-30U-4217Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-00285069292027-04-30U-4217Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-00376870522027-04-30U-4217Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-00385069292027-04-30U-4217Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-00476870522027-04-30U-4217Drug substance, Drug product2025-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202008-00485069292027-04-30U-4217Drug substance, Drug product2025-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N202008-00176870522027-04-30U-4217Drug substance, Drug product2012-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202008-00185069292027-04-30U-4217Drug substance, Drug product2013-09-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202008-00276870522027-04-30U-4217Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202008-00285069292027-04-30U-4217Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202008-00376870522027-04-30U-4217Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202008-00385069292027-04-30U-4217Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202008-00476870522027-04-30U-4217Drug substance, Drug product2025-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202008-00485069292027-04-30U-4217Drug substance, Drug product2025-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202008-00176870522027-04-30Drug substance, Drug product2012-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202008-00185069292027-04-30U-1423Drug substance, Drug product2013-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202008-00276870522027-04-30Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202008-00285069292027-04-30U-1423Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202008-00376870522027-04-30Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202008-00385069292027-04-30U-1423Drug substance, Drug productfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202008-00176870522027-04-30Drug substance, Drug product2012-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202008-00185069292027-04-30U-1423Drug substance, Drug product2013-09-06b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
Amyvid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLORBETAPIR F-1851 mCi/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6W15Z5R0RUInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb5a5043-0f51-11df-8a39-0800200c9a66Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-1200-48Amyvid100 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION10025
0002-1200-48Amyvid1 in 1 CANINJECTION, SOLUTION125
0002-1200-50Amyvid50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5025
0002-1200-50Amyvid1 in 1 CANINJECTION, SOLUTION125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-1200-50EA - Each0002-1200f47357cf-6fff-44fd-aa65-c55d386d508f12024-02-14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-1200AMYVID (FLORBETAPIR F 18) INJECTION, SOLUTION [ELI LILLY AND COMPANY]22Current NDC, Legacy NDC, 4 package rows20241115_bb5a5043-0f51-11df-8a39-0800200c9a66.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmyvidFLORBETAPIR F 18Eli Lilly and Companybb5a5043-0f51-11df-8a39-0800200c9a662025-12-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 202008
application number: NDA202008
ndc (product): 0002-1200

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-1200-30000021200301 VIAL, MULTI-DOSE in 1 CAN (0002-1200-30) > 30 mL in 1 VIAL, MULTI-DOSE2012-06-010000-00-00NoNoCurrent
0002-1200-48000021200481 VIAL, MULTI-DOSE in 1 CAN (0002-1200-48) / 100 mL in 1 VIAL, MULTI-DOSE2023-05-22NoNoCurrent
0002-1200-50000021200501 VIAL, MULTI-DOSE in 1 CAN (0002-1200-50) / 50 mL in 1 VIAL, MULTI-DOSE2012-06-010000-00-00NoNoCurrent