FDA.reportPublic FDA data

NDC 66887-004-01 - Testopel

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
66887-004
Requested NDC
66887-004-01
Package NDCs from labels
66887-004-01, 66887-004-10, 66887-004-20
Manufacturer
Endo USA, Inc.
Effective date
2025-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TESTOPEL ® (testosterone pellets) CIIIEndo USA, Inc.2025-07-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66887-004-01Testopel1 in 1 AMPULEPELLET128
66887-004-10Testopel10 in 1 BOXPELLET1028
66887-004-20Testopel100 in 1 BOXPELLET10028

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66887-004TESTOPEL (TESTOSTERONE) PELLET [ENDO USA, INC.]24Current NDC, Legacy NDC, 3 package rows20240425_03b9c0b1-5884-11e4-8ed6-0800200c9a66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66887-004-01EA - Each66887-0044b7e8575-f737-450c-b87e-33b927a8ddd212016-10-06
66887-004-10EA - Each66887-00407fa8d89-1f93-445d-8ea6-5669efff12a512014-11-05
66887-004-20EA - Each66887-004fed323f9-75ad-4d9b-87f2-c113f384f37c12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OTESTOPEL (TESTOSTERONE) PELLET [AUXILIUM PHARMACEUTICALS, INC.]11
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOPEL (TESTOSTERONE) PELLET [AUXILIUM PHARMACEUTICALS, INC.]11

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TestosteroneTESTOSTERONEEncube Ethicals, Inc.ca5d4865-356b-45e7-b603-fe299e450abc2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
Male SupportAGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALISDeseret Biologicals, Inc.29cefc89-3bb6-484e-84ab-116b5827a4c32026-06-15WarningsExact identifier
unii: 3XMK78S47O
TESTOSTERONETESTOSTERONEEncube Ethicals, Inc.44a04f66-fd2a-45c7-934e-8f14c023ce142026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONENorthstar Rx LLC65981b8a-d5cc-1964-7eac-a07f032c25712026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEXiromed, LLC28e8d504-5073-1d78-f351-bcb7c5188ee62026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 3XMK78S47O
Testosterone Gel, 1%TESTOSTERONE GEL, 1%Bryant Ranch Prepack353de205-d642-4f26-875b-b9ea4707a7552026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
Natural TestosteroneAVENA SATIVA. EPIMEDIUM, LYCOPODIUM CLAVATUM, DAMIANA, TESTOSTERONE, AGNUS CASTUSBioActive Nutritional, Inc.e2e6ce46-6729-4a63-90db-27e933379f452026-03-17WarningsExact identifier
unii: 3XMK78S47O
Female StimulantACONITICUM ACIDUM, CIS-, APIS VENENUM PURUM, AQUILEGIA VULGARIS, BOVISTA, CYPRIPEDIUM PUBESCENS, ESTRADIOL, FAECALIS (ALKALIGENES), FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, KREOSOTUM, LACHESIS MUTUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, MUTABILE BACILLUS (BACH), OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PINEAL GLAND (SUIS), PLACENTA TOTALIS SUIS, PROGESTERONE, SEPIA, TESTOSTERONE, UTERUS (SUIS)Deseret Biologicals, Inc.0d4b8cbf-8f57-43ca-a904-c69d9056c8652026-02-19WarningsExact identifier
unii: 3XMK78S47O
Vital Male Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CALADIUM SEGUINUM, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, NUPHAR LUTEUM, ORCHITINUM (SUIS), PANAX GINSENG, PHOSPHORICUM ACIDUM, TESTOSTERONE, THUJA OCCIDENTALIS, THYMUS (SUIS), THYROIDINUM (SUIS)Liddell Laboratories, Inc.5c9a9e1b-1145-4865-a983-fd808e85a1022026-01-29WarningsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONELupin Pharmaceuticals, Inc.29c8846f-121c-4958-9e03-3bd271c215582026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONELupin Pharmaceuticals, Inc.61387416-510d-40c5-9e2d-24bfb7f56d082026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
AndrobalanceDHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERONE, TESTOSTERONEBioActive Nutritional, Inc.e231695a-165a-419e-b594-34f9522503ac2025-12-18WarningsExact identifier
unii: 3XMK78S47O
High Vitality TabAGNUS CASTUS, AMBRA GRISEA, ESTRADIOL, L-DOPA, MELATONIN, PETROSELINUM SATIVUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, TESTOSTERONE, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), PROTEUS (MORGANI)Deseret Biologicalsd13cfd09-8f8d-4b39-b60e-0e7886af2a562025-12-11WarningsExact identifier
unii: 3XMK78S47O
Vital Male Sexual EnergyARNICA MONTANA, AVENA SATIVA, CALADIUM SEGUINUM, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, NUPHAR LUTEUM, ORCHITINUM, PANAX GINSENG, PHOSPHORICUM ACIDUM, POPULUS TREMULOIDES, TESTOSTERONE, THUJA OCCIDENTALIS, THYMUS SUIS, THYROIDINUM SUISLiddell Laboratories, Inc.7467edf6-50a2-4773-83e2-d266c23e63982025-11-20WarningsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEBryant Ranch Prepackc6c0a39e-0e75-4356-a052-c26c30c76b262025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
Testosterone Gel, 1%TESTOSTERONE GEL, 1%Encube Ethicals, Inc.7d655d6d-01da-488c-bd4e-c7fbe0ace38c2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEActavis Pharma, Inc.5834d34f-839d-412c-b74c-da1dad2cfa882025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEActavis Pharma, Inc.e18b4495-c5a3-4a7f-9636-1793207843812025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O
TestosteroneTESTOSTERONEBryant Ranch Prepack6c7d2dec-6492-4d53-b110-61ffeae9ee612025-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3XMK78S47O