FDA.reportPublic FDA data

NDC 68071-3840-01 - testosterone cypionate

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
68071-3840
Requested NDC
68071-3840-01
Package NDCs from labels
68071-3840-1, 68071-3840-01
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2025-05-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Testosterone Cypionate Injection, USP CIII Rx OnlyNuCare Pharmaceuticals, Inc.2025-05-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3840-1testosterone cypionate10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION101
68071-3840-1testosterone cypionate10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3840TESTOSTERONE CYPIONATE INJECTION, SOLUTION [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250507_346604c7-22d0-60c5-e063-6394a90abf0b.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 2 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Depo-TestosteroneTESTOSTERONE CYPIONATEAsclemed USA, Inc.2f72be32-ede6-44d9-88a0-0653b53a3e472025-08-27Warnings, Adverse reactionsExact identifier
unii: M0XW1UBI14
Testosterone CypionateTESTOSTERONE CYPIONATEHospira, Inc.6909596e-4bf7-4e11-8029-b89740a30aec2025-08-22Warnings, Adverse reactionsExact identifier
rxcui: 835840
rxcui: 2047882
unii: M0XW1UBI14
testosterone cypionateTESTOSTERONE CYPIONATENorthStar Rx LLC9ced69c7-cd37-efb6-1bf9-e21c01e56f5b2025-08-05Warnings, Adverse reactionsExact identifier
rxcui: 2047882
unii: M0XW1UBI14
testosterone cypionateTESTOSTERONE CYPIONATEXiromed LLCcab949ca-fde9-c5a9-5561-21e98d86d0782025-08-05Warnings, Adverse reactionsExact identifier
rxcui: 835840
rxcui: 2047882
unii: M0XW1UBI14
AZMIROTESTOSTERONE CYPIONATEAzurity Pharmaceuticals, Inc.235b5625-570d-3fba-e063-6394a90aa2d12025-07-25Warnings, Adverse reactionsExact identifier
rxcui: 2047882
unii: M0XW1UBI14
Testosterone CypionateTESTOSTERONE CYPIONATEWilshire Pharmaceuticals58ff6e0d-cc0a-4455-8254-d883d26a3b6d2025-07-24Warnings, Adverse reactionsExact identifier
rxcui: 835840
rxcui: 2047882
unii: M0XW1UBI14
Depo-TestosteroneTESTOSTERONE CYPIONATEPharmacia & Upjohn Company LLC735b5bf3-4464-412c-a072-1bd02f2e53802025-07-14Warnings, Adverse reactionsExact identifier
rxcui: 835840
unii: M0XW1UBI14
testosterone cypionateTESTOSTERONE CYPIONATEA-S Medication Solutionse9d48af3-9514-4dc5-972c-0c1f2547e5c62025-07-09Warnings, Adverse reactionsExact identifier
rxcui: 2047882
unii: M0XW1UBI14
Testosterone CypionateTESTOSTERONE CYPIONATECipla USA Inc.b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4782025-06-30Warnings, Adverse reactionsExact identifier
rxcui: 835840
rxcui: 2047882
unii: M0XW1UBI14
Testosterone CypionateTESTOSTERONE CYPIONATEPadagis US LLC4195516a-c8e6-457c-b805-43c9a3ca8b772025-06-03Warnings, Adverse reactionsExact identifier
rxcui: 835840
rxcui: 2047882
unii: M0XW1UBI14
Testosterone CypionateTESTOSTERONE CYPIONATEEugia US LLCf901e2b2-f143-4237-8e95-0d134585490b2025-06-03Warnings, Adverse reactionsExact identifier
rxcui: 835840
rxcui: 2047882
unii: M0XW1UBI14
Testosterone CypionateTESTOSTERONE CYPIONATEHikma Pharmaceuticals USA Inc.f60c5520-b336-44a2-95d5-f274939fa5952025-06-01Warnings, Adverse reactionsExact identifier
rxcui: 835840
rxcui: 2047882
unii: M0XW1UBI14
Testosterone CypionateTESTOSTERONE CYPIONATEHikma Pharmaceuticals USA Inc.5ca67491-4b30-4a47-af0a-be250215d1f02025-06-01Warnings, Adverse reactionsExact identifier
rxcui: 835840
unii: M0XW1UBI14
Testosterone CypionateTESTOSTERONE CYPIONATESun Pharmaceutical Industries, Inc.3653a602-4551-4e6c-84a7-31861f5dc4822025-05-30Warnings, Adverse reactionsExact identifier
rxcui: 835840
rxcui: 2047882
unii: M0XW1UBI14
TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATECipla USA Inc.78d55bad-4a5b-4e21-aeb8-a4c6346208be2025-05-09Warnings, Adverse reactionsExact identifier
rxcui: 835840
rxcui: 2047882
unii: M0XW1UBI14
testosterone cypionateTESTOSTERONE CYPIONATENuCare Pharmaceuticals, Inc.346604c7-22d0-60c5-e063-6394a90abf0b2025-05-05Warnings, Adverse reactionsExact identifier
application number: ANDA207742
ndc (package): 68071-3840-1
ndc (product): 68071-3840
ndc11 (package): 68071384001
rxcui: 835840
spl id: 34660d23-4120-6101-e063-6394a90ad6ab
spl set id: 346604c7-22d0-60c5-e063-6394a90abf0b
unii: M0XW1UBI14
testosterone cypionateTESTOSTERONE CYPIONATENuCare Pharmaceuticals,Inc.335ff614-15ec-0792-e063-6294a90a2f082025-04-22Warnings, Adverse reactionsExact identifier
application number: ANDA207742
rxcui: 2047882
unii: M0XW1UBI14
Testosterone CypionateTESTOSTERONE CYPIONATENuCare pgarmaceuticals,Inc.30b453b9-25ef-8262-e063-6394a90a24c22025-03-19Warnings, Adverse reactionsExact identifier
rxcui: 835840
unii: M0XW1UBI14
Testosterone CypionateTESTOSTERONE CYPIONATEBryant Ranch Prepack5a0bba6a-e8da-4b12-af63-eb27b1cca9e62025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 2047882
unii: M0XW1UBI14
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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