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#

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 2 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application number: ANDA080911
ndc (package): 66887-004-10
ndc (package): 66887-004-01
ndc (package): 66887-004-20
ndc (product): 66887-004
ndc11 (package): 66887000401
rxcui: 318240
rxcui: 404405
spl id: 0a13cf12-e51e-4d3d-a7c4-ea74712e6db2
spl set id: 03b9c0b1-5884-11e4-8ed6-0800200c9a66
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
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

Reported adverse events (FAERS/openFDA)#

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