FDA.reportPublic FDA data

NDC 67046-1480-03 - Medroxyprogesterone Acetate

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
67046-1480
Requested NDC
67046-1480-03
Package NDCs from labels
67046-1480-3, 67046-1480-03
Manufacturer
Coupler LLC
Effective date
2025-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Medroxyprogesterone Acetate - Coupler LLCCoupler LLC2025-01-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1480-3Medroxyprogesterone Acetate30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1480MEDROXYPROGESTERONE ACETATE TABLET [COUPLER LLC]1Current NDC, 1 package rows20250201_2cf48919-6de8-d3d0-e063-6394a90ac1bc.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 3 · 51 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.a0a92717-c1cb-40eb-a95a-1c5dfd32cfc02026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.1020bb60-4f13-4cd7-aaa1-c556752c84b72026-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000135
unii: C2QI4IOI2G
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEPrasco Laboratories987496bf-b4b0-409b-b745-f52ed0871f4e2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Depo-ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLC199cf13e-0859-4a73-9b45-e700d0cd10492026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.e3dfd683-d44e-427b-af06-70b9b698e0162026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000114
unii: C2QI4IOI2G
ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLCa586be28-96af-4fed-a13f-9b94fd4c74052026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000141
rxcui: 1000114
rxcui: 1000135
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPreferred Pharmaceuticals Inc.a9e05272-aa4e-4df8-b08b-481abca3e8fd2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000141
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPreferred Pharmaceuticals, Inc.37275fd0-eb24-40a4-a93f-b818bb98414e2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000114
unii: C2QI4IOI2G
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEMylan Pharmaceuticals Inc.2627eb11-06bf-4a45-9172-094468e3ca072026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000141
rxcui: 1000114
rxcui: 1000135
unii: C2QI4IOI2G
PremproCONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.fd0c0836-5d23-2183-da81-9dc7f42870522026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions5e817926-ba15-4d16-9463-88f6ff3bd3ac2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEXiromed LLC24544a5d-0cf5-a099-b57c-6e0843a405322026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEAmneal Pharmaceuticals LLC6457d70a-2f25-4935-8511-726d988f7a032026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATEEugia US LLC0655670a-d127-4e08-8a23-ace64b2503b22026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions816b9fd2-bc55-496b-846a-cabe7bbdecd62026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000114
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATENorthwind Health Company, LLC0de6142f-a78e-ae58-e063-6394a90adff02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000114
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEAmphastar Pharmaceuticals, Inc.fda1aa8a-5739-482a-b4f6-9741ef4d99772026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G

Reported adverse events (FAERS/openFDA)#

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