FDA.reportPublic FDA data

NDC11 53746007701

This exact 11-digit normalized identifier can correspond to more than one FDA hyphenation. FDA.report preserves the exact identifier and exposes every structurally valid candidate without guessing.

Possible FDA NDC forms#

Package NDC, Product root table
Package NDCProduct root
53746-0077-0153746-0077
53746-0077-153746-0077
53746-077-0153746-077

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esterified Estrogens and MethyltestosteroneESTERIFIED ESTROGENS AND METHYLTESTOSTERONEAmneal Pharmaceuticals of New York LLC316650b7-5770-4f1a-867d-68a72c60c8f22023-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 53746-077-01
ndc (product): 53746-077
ndc11 (package): 53746007701

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.