FDA.reportPublic FDA data

NDC 80425-0117-02 - Orphenadrine Citrate ER

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
80425-0117
Requested NDC
80425-0117-02
Package NDCs from labels
80425-0117-1, 80425-0117-2, 80425-0117-02
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 ER - 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
80425-0117-1Orphenadrine CitrateER30 in 1 BOTTLETABLET, EXTENDED RELEASE306
80425-0117-2Orphenadrine CitrateER60 in 1 BOTTLETABLET, EXTENDED RELEASE606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0117ORPHENADRINE CITRATE ER (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_b5a6846a-ebb3-1fdd-e053-2a95a90a4130.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0117-1EA - Each80425-01176875530b-65eb-4b30-8141-3c4a785f548a12023-06-06
80425-0117-2EA - Each80425-0117e8276d9e-8686-4581-a97e-dd1e868f4c5c12023-10-16

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 1 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORPHENADRINE CITRATEORPHENADRINE CITRATEREMEDYREPACK INC.7905e80f-b60b-48e8-8e63-a3e50211bfe42026-08-10Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
Orphenadrine CitrateORPHENADRINE CITRATEPreferred Pharmaceuticals, Inc.8ca9438d-320f-4499-aee7-6b8ca7cccc652026-08-07Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
Orphenadrine CitrateORPHENADRINE CITRATESt. Mary's Medical Park Pharmacy59000b66-166e-75d2-e053-2a91aa0af3c02026-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
ORPHENADRINE CITRATEORPHENADRINE CITRATEBryant Ranch Prepack1b4e379e-8051-421f-a0f4-ad9e6fb9476a2026-02-26Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication Solutions80ef7fb4-7c50-4d25-915e-f9d4a2ccd1992026-01-20Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
NorgesicORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEGalt Pharmaceuticals, LLCbe2761bc-e537-4039-846a-2ffa3d8b2afc2026-01-08Warnings, Adverse reactionsExact identifier
unii: X0A40N8I4S
ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.87d78229-f022-4b42-a03c-4e6a985c714f2026-01-07Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
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
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
ndc (package): 80425-0117-2
ndc (package): 80425-0117-1
ndc (product): 80425-0117
ndc11 (package): 80425011702
rxcui: 994521
spl id: 2a996b2b-b5dc-65e7-e063-6394a90adeed
spl set id: b5a6846a-ebb3-1fdd-e053-2a95a90a4130
unii: X0A40N8I4S
ORPHENADRINE CITRATEORPHENADRINE CITRATEAdvanced Rx Pharmacy of Tennessee, LLCfc63d413-39bd-409d-e053-6294a90a14632024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
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
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
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

Reported adverse events (FAERS/openFDA)#

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