FDA.reportPublic FDA data

NDC 57377-100 - Testo-100

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57377-100
Package NDCs from labels
57377-100-01
Manufacturer
Advanced Pharmaceutical Technology, Inc.
Effective date
2024-09-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Testo-100Advanced Pharmaceutical Technology, Inc.2024-09-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57377-100-01Testo-10010 in 1 AMPULEPELLET, IMPLANTABLE1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57377-100TESTO-100 (TESTOSTERONE,USP) PELLET, IMPLANTABLE [ADVANCED PHARMACEUTICAL TECHNOLOGY, INC.]101 package rows20240925_593ebdf5-54c6-7fae-e053-2991aa0a8e4a.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 4 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TestosteroneTESTOSTERONEActavis Pharma, Inc.e18b4495-c5a3-4a7f-9636-1793207843812025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
TestosteroneTESTOSTERONEBryant Ranch Prepack6c7d2dec-6492-4d53-b110-61ffeae9ee612025-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
testosteroneTESTOSTERONENorthstar Rx LLC2d55b825-8eab-4091-bdf2-9c52d111b8eb2025-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
testosteroneTESTOSTERONEPadagis Israel Pharmaceuticals Ltd54fcdcb9-fb0e-4164-9e51-f2a5feae32172025-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEStrides Pharma Science Limitedee54c393-bcfe-4a52-b7b3-1da8750f35d92025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEActavis Pharma, Inc.4f3c2c0a-7dab-4b50-9cae-869c3c2a84982025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
testosteroneTESTOSTERONEBryant Ranch Prepack9e10a37a-9c40-456b-a362-2fa8eae31e842025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
Natesto nasal gelTESTOSTERONEAcerus Pharmaceuticals Corporationdea6bed1-eaca-11e3-ac10-0800200c9a662025-07-22Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestopelTESTOSTERONEEndo USA, Inc.03b9c0b1-5884-11e4-8ed6-0800200c9a662025-07-17Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestimTESTOSTERONEEndo USA, Inc.9f2aae1f-898d-4955-be31-678e0cf853952025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
VogelxoTESTOSTERONEUpsher-Smith Laboratories, LLC2dd150f6-cdfd-4d51-8888-12b288f262622025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TESTOSTERONETESTOSTERONEAlembic Pharmaceuticals Inc.e39289aa-681c-47ec-9461-52e7f17e5d712025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEAmneal Pharmaceuticals NY LLCf9888b14-67f4-4c87-8f7b-d51baef9891b2025-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEUpsher-Smith Laboratories, LLCa887020f-b41f-49fe-8379-f01147b2a7962025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
testosteroneTESTOSTERONEPadagis Israel Pharmaceuticals Ltdc0c56607-e995-4bed-9c62-e33a722b38b52025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
testosteroneTESTOSTERONEBryant Ranch Prepack78384754-5883-46b1-84e7-c063b4b4be822025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEUpsher-Smith Laboratories, LLC10dab294-6a43-4bb3-9d91-2d200c624ffb2025-06-10Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONECipla USA Inc.6a46b5de-5d95-4570-91a6-3e4278028c592025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
Female StimulantLILIUM TIGRINUM, BOVISTA, CYPRIPEDIUM PUBESCENS, HYDRASTIS CANADENSIS, PETROSELINUM SATIVUM, AQUILEGIA VULGARIS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), KREOSOTUM, OOPHORINUM (SUIS), UTERUS (SUIS), FOLLICULINUM, LACHESIS MUTUS, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, SEPIA, PINEAL GLAND (SUIS), HYPOPHYSIS SUIS, ACONITICUM ACIDUM CIS-, APIS VENENUM PURUM, ESTRADIOL, PROGESTERONE, TESTOSTERONE, PLACENTA TOTALIS SUIS, FAECALIS (ALKALIGENES), MUTABILE BACILLUS (BACH)Deseret Biologicals, Inc.18d072ec-93e1-4e20-82db-98e80b81c3632025-05-27WarningsExact identifier
unii: 3XMK78S47O

Reported adverse events (FAERS/openFDA)#

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