FDA.reportPublic FDA data

NDC 58198-0327 - Compudose

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
58198-0327
Package NDCs from labels
58198-0327-1
Manufacturer
Elanco US Inc.
Effective date
2025-10-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Compudose - Elanco US Inc.Elanco US Inc.2025-10-28OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0327-1Compudose20 in 1 CARTRIDGEIMPLANT206
58198-0327-1Compudose5 in 1 CARTONIMPLANT56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-0327COMPUDOSE (ESTRADIOL) IMPLANT [ELANCO US INC.]52 package rows20240216_386fc0aa-c4a7-4dff-86bf-d79facb6d6cc.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 1 of 9 · 170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Estriora CreamESTRIOL AND ESTRADIOL CREAMGuangzhou Shunfei Network Technology Co., Ltd.5a53c026-aa7c-6c09-e063-6394a90a36e12026-08-31WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionsc8a2d29c-299c-4559-b859-87b303a4af812026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
GynobalanceDEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONEBioActive Nutritional, Inc.61fa6e6e-42f5-4992-87b5-0770218abc8c2026-08-24WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLTrigen Laboratories, LLCe84ad638-6768-41aa-b2b8-e2514ef638812026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
MinivelleESTRADIOLNoven Therapeutics, LLC6c5c47ab-28ee-11e1-bfc2-0800200c9a662026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLRedpharm Drug5718f042-e8c0-b721-e063-6294a90a5bef2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLA-S Medication Solutions5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutionse166bdf6-eb60-49b8-9747-2a33c3e3461b2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutions1521007a-546d-421e-99e1-e10d90c0b0902026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLANI Pharmaceuticals, Inc.ff28c624-906d-459c-8b8c-27cb1a664e122026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLRedpharm Drug546c168d-2a85-69b6-e063-6294a90a22ac2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepacke6bf2abc-71ae-4e79-a37b-164c98ba746a2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions34bcec8e-c7a6-4a1c-9884-4d4efe024bb92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLREMEDYREPACK INC.41f7a56c-4ce3-4cc6-803e-1ff662efef902026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLREMEDYREPACK INC.59a4b68d-a507-4809-a0c8-fd9799986d122026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionsba935918-39b3-4b56-bd83-78a29958e6d82026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions1c38f0d0-a360-4b66-bc0e-7d54e92465a12026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLREMEDYREPACK INC.477cb52e-8ce2-491f-94a0-869ff60bf7ab2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionseacafc4a-2fa8-403d-8df7-2bc92d73a54f2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionsee5460ab-27e7-487a-a89c-bf8735399be62026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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