FDA.reportPublic FDA data

TAUVID

Product NDC
0002-1210
Requested package NDC
0002-1210-30
11-digit product format
000021210
Labeler code
0002
Product ID
0002-1210_d03b2693-0231-4df4-a037-63017a42e85a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flortaucipir F-18
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eli Lilly and Company
Application
NDA212123
Marketing category
NDA
Marketing start
2020-05-28
Marketing end
0000-00-00
Substance
FLORTAUCIPIR F-18
Active strength
51 mCi/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0002-12100002-1210-30DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N212123-001TAUVIDFLORTAUCIPIR F-1830ML (8.1-51mCi/ML)SOLUTION / INTRAVENOUSRLD2020-05-28
N212123-002TAUVIDFLORTAUCIPIR F-1850ML (8.1-51mCi/ML)SOLUTION / INTRAVENOUSRLD2020-05-28
N212123-003TAUVIDFLORTAUCIPIR F-1850ML (8.1-100mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2022-07-01
N212123-004TAUVIDFLORTAUCIPIR F-18100ML (8.1-100mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2022-07-01

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212123-00189325572032-05-26Drug substance2020-06-11
N212123-00289325572032-05-26Drug substance2020-06-11
N212123-00389325572032-05-26Drug substance2022-09-08
N212123-00489325572032-05-26Drug substance2022-09-08

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N212123-001TAUVID30ML (8.1-51mCi/ML)SOLUTION / INTRAVENOUSRLD2020-05-28a50c72e98297…
2026-08-01 22:54:322026-06N212123-002TAUVID50ML (8.1-51mCi/ML)SOLUTION / INTRAVENOUSRLD2020-05-28a50c72e98297…
2026-08-01 22:54:322026-06N212123-003TAUVID50ML (8.1-100mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2022-07-01a50c72e98297…
2026-08-01 22:54:322026-06N212123-004TAUVID100ML (8.1-100mCi/ML)SOLUTION / INTRAVENOUSRLD, RS2022-07-01a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N212123-00189325572032-05-26Drug substance2020-06-11a50c72e98297…
2026-08-01 22:54:322026-06N212123-00289325572032-05-26Drug substance2020-06-11a50c72e98297…
2026-08-01 22:54:322026-06N212123-00389325572032-05-26Drug substance2022-09-08a50c72e98297…
2026-08-01 22:54:322026-06N212123-00489325572032-05-26Drug substance2022-09-08a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TAUVIDFLORTAUCIPIR F-18Eli Lilly and Companyb483abad-5230-462a-adfb-1a65160f01d02025-12-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 212123
application number: NDA212123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-1210-30000021210301 VIAL, MULTI-DOSE in 1 CAN (0002-1210-30) > 30 mL in 1 VIAL, MULTI-DOSE2020-05-280000-00-00NoNoCurrent