FDA.reportPublic FDA data

NDC 50090-0169-01 - 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
50090-0169
Requested NDC
50090-0169-01
Package NDCs from labels
50090-0169-0, 50090-0169-1, 50090-0169-2, 50090-0169-5, 50090-0169-01
Manufacturer
A-S Medication Solutions
Effective date
2026-01-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Orphenadrine Citrate - A-S Medication SolutionsA-S Medication Solutions2026-01-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0169-0Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE2019
50090-0169-1Orphenadrine Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE3019
50090-0169-2Orphenadrine Citrate14 in 1 BOTTLETABLET, EXTENDED RELEASE1419
50090-0169-5Orphenadrine Citrate60 in 1 BOTTLETABLET, EXTENDED RELEASE6019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0169ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 4 package rows20231204_80ef7fb4-7c50-4d25-915e-f9d4a2ccd199.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0169-0EA - Each50090-01698d113a9c-ac81-480d-8b7d-2c1cbc2a9a3e12018-08-13
50090-0169-1EA - Each50090-016905646391-f849-481e-941d-bf62a5bb1a8d12018-08-13
50090-0169-2EA - Each50090-016929b136af-8ccb-42cb-9790-ba341f92f4ab12018-08-13
50090-0169-5EA - Each50090-0169a83b1cdd-583f-4fd5-8337-0d90a87e252f12018-08-13

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 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
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
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
Orphenadrine CitrateORPHENADRINE CITRATESt. Mary's Medical Park Pharmacy59000b66-166e-75d2-e053-2a91aa0af3c02026-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA040284
rxcui: 994521
unii: X0A40N8I4S
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
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
ndc (package): 50090-0169-1
ndc (package): 50090-0169-5
ndc (package): 50090-0169-0
ndc (package): 50090-0169-2
ndc (product): 50090-0169
ndc11 (package): 50090016901
rxcui: 994521
spl id: a11270c6-fe5e-4cfd-9a1e-f11abb0fe4a0
spl set id: 80ef7fb4-7c50-4d25-915e-f9d4a2ccd199
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

Reported adverse events (FAERS/openFDA)#

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