FDA.reportPublic FDA data

LUMISIGHT

Product NDC
82292-040
Requested package NDC
82292-040-10
11-digit product format
822920040
Labeler code
82292
Product ID
82292-040_8a6aec36-4e75-4cd0-a250-cb126128bbd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pegulicianine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Lumicell, Inc.
Application
NDA214511
Marketing category
NDA
Marketing start
2024-04-17
Substance
PEGULICIANINE
Active strength
10 mg/mL
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214511-001LUMISIGHTPEGULICIANINE ACETATEEQ 39MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-17

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214511-001115923962030-09-01Drug substance2025-01-17
N214511-00191554712031-10-12U-38902024-05-01
N214511-001102857592031-12-08U-38902024-05-01
N214511-00190329652031-12-08U-38902024-05-01
N214511-00195328352031-12-08U-38902024-05-01
N214511-00197635772034-09-14U-3890Drug substance, Drug product2024-05-01

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N214511-001NCE2029-04-17

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
2026-02-19 14:30 UTC2026-02N214511-001LUMISIGHTEQ 39MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214511-001LUMISIGHTEQ 39MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214511-001LUMISIGHTEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-178072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214511-001LUMISIGHTEQ 39MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-04-17a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N214511-001115923962030-09-01Drug substance2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214511-00191554712031-10-12U-38902024-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214511-001102857592031-12-08U-38902024-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214511-00190329652031-12-08U-38902024-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214511-00195328352031-12-08U-38902024-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214511-00197635772034-09-14U-3890Drug substance, Drug product2024-05-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214511-001115923962030-09-01Drug substance2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214511-00191554712031-10-12U-38902024-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214511-001102857592031-12-08U-38902024-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214511-00190329652031-12-08U-38902024-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214511-00195328352031-12-08U-38902024-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214511-00197635772034-09-14U-3890Drug substance, Drug product2024-05-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N214511-001115923962030-09-01Drug substance2025-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214511-00191554712031-10-12U-38902024-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214511-001102857592031-12-08U-38902024-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214511-00190329652031-12-08U-38902024-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214511-00195328352031-12-08U-38902024-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214511-00197635772034-09-14U-3890Drug substance, Drug product2024-05-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214511-001115923962030-09-01Drug substance2025-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214511-00191554712031-10-12U-38902024-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214511-001102857592031-12-08U-38902024-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214511-00190329652031-12-08U-38902024-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214511-00195328352031-12-08U-38902024-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214511-00197635772034-09-14U-3890Drug substance, Drug product2024-05-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214511-001115923962030-09-01Drug substance2025-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214511-00191554712031-10-12U-38902024-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214511-001102857592031-12-08U-38902024-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214511-00190329652031-12-08U-38902024-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214511-00195328352031-12-08U-38902024-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214511-00197635772034-09-14U-3890Drug substance, Drug product2024-05-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214511-00191554712031-10-12U-38902024-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214511-001102857592031-12-08U-38902024-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214511-00190329652031-12-08U-38902024-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214511-00195328352031-12-08U-38902024-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214511-00197635772034-09-14U-3890Drug substance, Drug product2024-05-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214511-00191554712031-10-12U-38902024-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214511-001102857592031-12-08U-38902024-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214511-00190329652031-12-08U-38902024-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214511-00195328352031-12-08U-38902024-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214511-00197635772034-09-14U-3890Drug substance, Drug product2024-05-012680178bc6a6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N214511-001NCE2029-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214511-001NCE2029-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N214511-001NCE2029-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214511-001NCE2029-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214511-001NCE2029-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214511-001NCE2029-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214511-001NCE2029-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214511-001NCE2029-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214511-001NCE2029-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214511-001NCE2029-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214511-001NCE2029-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214511-001NCE2029-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214511-001NCE2029-04-171e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214511-001NCE2029-04-17a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGULICIANINE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T6HE85WN0QInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7160e774-663a-43e4-ba4a-06cc57830e66Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
b61dce11-7b27-4241-a419-691270f12522Product name120250130
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82292-040-01LUMISIGHT3.9 mL in 1 VIALInjection, powder, lyophilized,3.93
82292-040-10LUMISIGHT10 in 1 CARTONInjection, powder, lyophilized,103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82292-040-01EA - Each82292-0405210a929-a7fa-4725-9470-fe0be48fa84a12024-06-10
82292-040-10EA - Each82292-040d4690cf3-9f57-4720-bb2a-a43e673a6ebd12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82292-040LUMISIGHT (PEGULICIANINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LUMICELL, INC.]2Current NDC, 2 package rows20240605_7160e774-663a-43e4-ba4a-06cc57830e66.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
LUMISIGHTPEGULICIANINELumicell, Inc.7160e774-663a-43e4-ba4a-06cc57830e662026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 214511
application number: NDA214511
ndc (package): 82292-040-10
ndc (product): 82292-040
ndc11 (package): 82292004010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82292-040-108229200401010 VIAL in 1 CARTON (82292-040-10) / 3.9 mL in 1 VIAL (82292-040-01) 10 vial2024-04-17NoNoCurrent