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 2 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORPHENADRINE CITRATEORPHENADRINE CITRATENorthwind Health Company, LLC106be130-b4f8-5ca1-e063-6294a90a15902026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
Norgesic ForteORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEPoly Pharmaceuticals, Inc.85a3b808-b476-f2f0-e053-2a91aa0af21f2025-12-30Warnings, Adverse reactionsExact identifier
unii: X0A40N8I4S
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: 3NXW29V3WO
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: 3NXW29V3WO
Orphenadrine Citrate, Aspirin and CaffeineORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEAtland Pharmaceuticals, LLC7776aae6-3cbd-4aed-9aac-4bed80339e272025-10-17Warnings, Adverse reactionsExact identifier
unii: X0A40N8I4S
ORPHENGESIC FORTEORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEGalt Pharmaceuticals, LLC5bc485db-9d96-4291-aaa3-2a96ebf3098a2025-10-16Warnings, Adverse reactionsExact identifier
unii: X0A40N8I4S
Orphenadrine Citrate, Aspirin and CaffeineORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEAtland Pharmaceuticals, LLC61ca2af1-081c-411c-90ce-ec6d9e3157b22025-10-16Warnings, Adverse reactionsExact identifier
unii: X0A40N8I4S
ORPHENADRINE CITRATEORPHENADRINE CITRATELupin Pharmaceuticals, Inc.7b76c8a7-dd0c-481c-8299-26dfd38ce0662025-09-10Warnings, Adverse reactionsExact identifier
application number: ANDA040284
ndc (product): 43386-480
rxcui: 994521
spl id: e80ecc89-bd45-4796-850b-c379a79ac7ab
spl set id: 7b76c8a7-dd0c-481c-8299-26dfd38ce066
unii: X0A40N8I4S
Orphenadrine Citrate ERORPHENADRINE CITRATEAdvanced Rx Pharmacy of Tennessee, LLCb5a6846a-ebb3-1fdd-e053-2a95a90a41302024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
ORPHENADRINE CITRATEORPHENADRINE CITRATEAdvanced Rx Pharmacy of Tennessee, LLCfc63d413-39bd-409d-e053-6294a90a14632024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA040284
ndc (package): 80425-0340-1
ndc (package): 80425-0340-2
ndc (product): 80425-0340
ndc11 (package): 80425034001
rxcui: 994521
spl id: 2a9ba8f4-6cf3-e827-e063-6394a90a0300
spl set id: fc63d413-39bd-409d-e053-6294a90a1463
unii: X0A40N8I4S
Orphenadrine CitrateORPHENADRINE CITRATELake Erie Medical DBA Quality Care Products LLC233915f1-7d58-4b4c-a2bb-e73179d61d072024-12-16Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
Orphenadrine CitrateORPHENADRINE CITRATEBryant Ranch Prepack8408d24e-3948-548d-bb12-b1edf0c05e122024-08-27Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
Orphenadrine CitrateORPHENADRINE CITRATENuCare Pharmaceuticals, Inc.3eb1b1cc-ed7a-6f0f-e054-00144ff88e882024-08-13Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S

Reported adverse events (FAERS/openFDA)#

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