FDA.reportPublic FDA data

NDC 63629-8826-01 - 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
63629-8826
Requested NDC
63629-8826-01
Package NDCs from labels
63629-8826-1, 63629-8826-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Medroxyprogesterone Acetate - Bryant Ranch PrepackBryant Ranch Prepack2024-07-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8826-1Medroxyprogesterone Acetate100 in 1 BOTTLETABLET100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8826MEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240724_a88b33ff-842b-4a5b-a27e-9c2b9e85a4d7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8826-1EA - Each63629-882609de7d0f-8dc8-43d9-bbfa-97abec57444212021-12-08

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 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Depo-SubQ ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLC390087a6-f3c3-4f0b-a930-79acf412f1532025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPD-Rx Pharmaceuticals, Inc.6a541749-5d14-44aa-a409-5e51f5bbf9292025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000135
unii: C2QI4IOI2G
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutionsbfdf335d-1cbb-4533-9fde-99a9c71f75042025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000141
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions788df737-e990-4b5e-accd-af13c3b2bf8b2025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000135
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEAmneal Pharmaceuticals NY LLCa80560e1-96dd-4380-b3e1-d52719ccdd4b2025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATECoupler LLC2cf48919-6de8-d3d0-e063-6394a90ac1bc2025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000135
unii: C2QI4IOI2G
Medroxyprogesterone Acetate Injectable SuspensionMEDROXYPROGESTERONE ACETATEHikma Pharmaceuticals USA Inc.0476eac5-d96c-4910-aa86-1ddeeefefe502025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPD-Rx Pharmaceuticals, Inc.437edd12-2c08-4df4-8cf7-64c47e4779ac2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000114
unii: C2QI4IOI2G
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepacka36c89b7-9463-4d00-a4d3-021d770900772024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000114
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepacka88b33ff-842b-4a5b-a27e-9c2b9e85a4d72024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
ndc (package): 63629-8826-1
ndc (product): 63629-8826
ndc11 (package): 63629882601
rxcui: 1000141
spl id: 301b0e97-5e47-416f-bdca-39aaeb41707f
spl set id: a88b33ff-842b-4a5b-a27e-9c2b9e85a4d7
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepackbdb89690-ced2-48e1-bb1a-e5eccfeda8eb2024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000114
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepackd9ad130b-8f9a-4a0f-beb4-b692b6d3c5ca2024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000135
unii: C2QI4IOI2G
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATENuCare Pharmaceuticals,Inc.5c8ffae3-3b3e-197e-e053-2a91aa0a59e32024-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
rxcui: 1000114
unii: C2QI4IOI2G
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 368GB5141J
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATETeva Pharmaceuticals USA, Inc.9eb200b0-db96-4a51-87ea-04db862978c82024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040159
ndc (product): 0555-0873
rxcui: 1000141
rxcui: 1000114
rxcui: 1000135
spl id: b8f519a9-a8d0-4dd5-b138-564fb579c461
spl set id: 9eb200b0-db96-4a51-87ea-04db862978c8
unii: C2QI4IOI2G

Reported adverse events (FAERS/openFDA)#

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