FDA.reportPublic FDA data

NDC 80425-0340-01 - ORPHENADRINE CITRATE

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
80425-0340
Requested NDC
80425-0340-01
Package NDCs from labels
80425-0340-1, 80425-0340-2, 80425-0340-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ORPHENADRINE CITRATE - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0340-1ORPHENADRINE CITRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE303
80425-0340-2ORPHENADRINE CITRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0340ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 2 package rows20250102_fc63d413-39bd-409d-e053-6294a90a1463.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0340-1EA - Each80425-03405d392b19-64f9-4fac-ae6b-8682fc50bd9112023-07-06
80425-0340-2EA - Each80425-0340c5510cef-7513-4a88-8e89-ff89c258f3c912023-10-16

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 3 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orphenadrine citrateORPHENADRINE CITRATEHikma Pharmaceuticals USA Inc.ed406e8a-ec00-4711-ae2b-3c5af4f154382024-08-08Warnings, Adverse reactionsExact identifier
unii: X0A40N8I4S
Orphenadrine CitrateORPHENADRINE CITRATERedPharm Drug1cff761d-e594-a9e6-e063-6394a90a1fd52024-07-11Warnings, Adverse reactionsExact identifier
rxcui: 994521
unii: X0A40N8I4S
Orphenadrine CitrateORPHENADRINE CITRATESandoz Inc239018ff-cec6-46de-ae9d-26c9ec034a322024-03-22Warnings, Adverse reactionsExact identifier
rxcui: 994521
unii: X0A40N8I4S
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: 3NXW29V3WO
Equate Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Wal-Mart Stores, Inc.91fb8fb5-b871-4535-e053-2995a90a9b162023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Sunmark Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC043ccc34-44ee-416a-88bc-f247774e90752023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Rite Aid Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Rite Aid Corporationfa1b5b66-9643-e9a7-e053-6394a90ae3cf2023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
unii: 3NXW29V3WO
Walgreens Multi-Symptom Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEWalgreen Co.a03789ce-66bd-7b12-e053-2995a90af85a2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
Walgreens Lubricant Eye Drops Preservative FreeDEXTRAN 70, HYPROMELLOSEWalgreen Company9b383e41-e116-1c12-e053-2a95a90ab25f2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
unii: 3NXW29V3WO
Orphenadrine CitrateORPHENADRINE CITRATEProficient Rx LPcf620257-7497-44c1-9853-87f96d262fbd2023-12-01Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
Orphenadrine CitrateORPHENADRINE CITRATESagent Pharmaceuticalsc8d8596a-b81f-4b83-a2f3-a55922ca4a822023-11-14Warnings, Adverse reactionsExact identifier
unii: X0A40N8I4S
Orphenadrine CitrateORPHENADRINE CITRATEProficient Rx LP37e6a157-5d0d-4887-9a26-ed5521fb08e62019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 994521
unii: X0A40N8I4S
Orphenadrine CitrateORPHENADRINE CITRATEActavis Pharma, Inc.aec8ad3a-f717-4e74-b7b9-19debdaad79a2016-07-20Warnings, Adverse reactionsExact identifier
unii: X0A40N8I4S

Reported adverse events (FAERS/openFDA)#

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