FDA.reportPublic FDA data

PRESIGEN

Product NDC
84761-0003
11-digit product format
847610003
Labeler code
84761
Product ID
84761-0003_4710495d-4199-d77e-e063-6394a90ab9b9
Type
HUMAN OTC DRUG
Nonproprietary name
PRESIGEN
Dosage form
CAPSULE
Route
ORAL
Labeler
Tejeda Enterprises Incorporated
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-10-01
Substance
ALLIUM SATIVUM WHOLE; MOMORDICA CHARANTIA STEM
Active strength
2000; 740 mg/2U; mg/2U
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct84761-0003IInactivated by FDA2026-10-05
excluded packagepackage84761-000384761-0003-1IInactivated by FDA2026-10-05

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
PRESIGEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLIUM SATIVUM WHOLE2000 mg/2U
MOMORDICA CHARANTIA STEM740 mg/2U

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IIF21WT8O3Internal UNII lookup
3CLE6O58O9Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47104938-f3b7-d8fd-e063-6394a90a0821Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84761-0003-2PRESIGEN60 U in 1 PACKAGECAPSULE605
84761-0003-1PRESIGEN60 U in 1 PACKAGECAPSULE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84761-0003PRESIGEN CAPSULE [TEJEDA ENTERPRISES INCORPORATED]3Current NDC, 1 package rows20241106_2431aa5f-1cad-4356-e063-6394a90aec07.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
PRESIGENPRESIGENTejeda Enterprises Incorporated47104938-f3b7-d8fd-e063-6394a90a08212025-12-28WarningsExact identifier
ndc (product): 84761-0003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84761-0003-18476100030160 U in 1 PACKAGE60 uHistorical
84761-0003-28476100030260 U in 1 PACKAGE (84761-0003-2) 60 u2024-10-01NoNoCurrent