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 5 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hormone BalanceACETALDEHYDE, DOPAMINE HYDROCHLORIDE, DHEA (DEHYDROEPIANDROSTERONE), 7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, FOLLICULINUM, OOPHORINUM (SUIS), CHOLESTERINUM, PROGESTERONE, TESTOSTERONE, CORTISONE ACETICUM, ALDOSTERONE, ANDROSTERONE, FOLLICLE STIMULATING HORMONEDr. Donna Restivo DC421707d6-31c1-4d57-b017-796fc872efe42025-05-23WarningsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEActavis Pharma, Inc.7227ab2f-c8ef-4bab-92ab-3092182abcc92025-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
TestosteroneTESTOSTERONEZoe Processing0bb2581c-5a65-469b-8f9a-954ac9cc90fb2025-02-03WarningsExact identifier
unii: 3XMK78S47O
Strength FALPHA-KETOGLUTARICUM ACIDUM, ISOLEUCINE, L-ARGININE, L CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, ESTRADIOL, FOLLICULINUM, PROGESTERONE, TESTOSTERONE, OOPHORINUM (SUIS)BioActive Nutritional, Inc.a4f3a8e7-0a28-4aa0-ba0c-201807d62c962025-01-03WarningsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEPrasco Laboratories68b2375d-0365-4797-bc3d-63531c9f42fd2024-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
testosteroneTESTOSTERONEBryant Ranch Prepack5be74193-de73-436d-a9a1-35a857bc8e0c2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
Strength MARALIA QUINQUEFOLIA, AVENA SATIVA, DAMIANA, EPIMEDIUM GRANDIFLORUM, GLUTATHIONE, L-ARGININE, L-LEUCINE, L-ORNITHINE, L-VALINE, TESTOSTERONE, SABAL SERRULATA, SEPIABioActive Nutritional, Inc.8eda49aa-da6c-4e06-926c-73f35f33e5d82024-10-18WarningsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEPrasco Laboratories0d84e5a6-11e9-4940-8991-21c611c4c32f2024-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
HP AxisARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONEDeseret Biologicals, Inc.402f5b05-c71e-4dba-bc2b-049aee42952a2024-09-23WarningsExact identifier
unii: 3XMK78S47O
216a5bc2-69ad-0a00-e063-6394a90ac5ed593ebdf5-54c6-7fae-e053-2991aa0a8e4a2024-09-05WarningsExact identifier
spl id: 216a5bc2-69ad-0a00-e063-6394a90ac5ed
spl set id: 593ebdf5-54c6-7fae-e053-2991aa0a8e4a
Immune ForteDEHYDROEPIANDROSTERONE (DHEA), ESTRADIOL, HYPOPHYSIS SUIS, PREGNENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)BioActive Nutritional, Inc.9c355245-260a-464b-abcf-95416b49caa32024-08-29WarningsExact identifier
unii: 3XMK78S47O
testosteroneTESTOSTERONEBryant Ranch Prepackd22a072f-529b-4878-90fc-4365d9dc67e62024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
ProstatePETROSELINUM SATIVUM, POPULUS TREMULOIDES, SABAL SERRULATA, CHIMAPHILA UMBELLATA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, EQUOL, KREOSOTUM, NADIDUM, TESTOSTERONE, PROSTATE (SUIS), SUCCINICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, CONIUM MACULATUM, PROTEUS (MIRABILIS), PROTEUS (VULGARIS)Deseret Biologicals, Inc.776af24a-d9c1-4ecd-8e5d-0ab32c60e7152024-08-19WarningsExact identifier
unii: 3XMK78S47O
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
Male BalanceAVENA SATIVA, HEPAR SUIS, ORCHITINUM (SUIS), TESTOSTERONE, AGNUS CASTUS, DAMIANA, GINKGO BILOBA, HYPOTHALAMUS (SUIS), LYCOPODIUM CLABATUM, HUMAN GROWTH HORMONE, EPIMEDIUM GRANDIFLORUM, SEROTONIN (HYDROCHLORIDE)Energique,Inc.297fe55b-ac23-4a7f-bbbe-1005c00669312024-04-26WarningsExact identifier
unii: 3XMK78S47O
Male StimulantARALIA QUINQUEFOLIA, AGNUS CASTUS, ASCORBICUM ACIDUM, CALADIUM SEGUINUM, KALI BROMATUM, CANTHARIS, DAMIANA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, ORCHITINUM (SUIS), PROSTATE (SUIS), STRYCHNINUM PHOSPHORICUM, CONIUM MACULATUM, DIENCEPHALON (SUIS), HEART (SUIS), FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SELENIUM METALLICUM, ZINCUM METALLICUM, PINEAL GLAND (SUIS), CORTISONE ACETICUM, MANGANUM PHOSPHORICUM, LYCOPODIUM CLAVATUM, TESTOSTERONE, MORGAN GAERTNERDeseret Biologicals, Inc.d48437d6-a54f-4e11-bcfb-9e0d5c1e98da2024-04-15WarningsExact identifier
unii: 3XMK78S47O
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
Dr Dale Wellness NU Fem 1 2 3 All In One Topical HomeopathicDHEA,ADRENAL CORTISOL,GLANDULA SUPRARENALIS SUIS,HUMAN GROWTH HORMONE,IGF-I,IGF-II ,HYPOTHALAMUS,PITUITARY,PLACENTA,LIVER,THYMUS,RNA,DNA,ESTROGENIUM,ESTRADIOLINUM,SANGUINARA CANDENSIS,OOPHORINUM,PROGESTERONIUM,PITITUARINUM,PINEAL,FOLLICULINUM,OVARINUM,CHELADONIUM,SULPHUR,SEPIA,LAGENINE ,TESTOSTERONE,CIMICIFUGA BLACK COHOSH,LILIUM TIGRINUM,GRAPHITES,KALI PHOSPHORICUM ,CAUSTICUM,CALCAREA CARBONICA,PHYTOLACCA,SCROPHULARIA NODOSADMD Clinical Naturopathy7679472c-bc6a-40c1-8e66-adc0b6ca18b42024-03-21WarningsExact identifier
unii: 3XMK78S47O

Reported adverse events (FAERS/openFDA)#

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