FDA.reportPublic FDA data

NDC 50090-4727-01 - CYCLOBENZAPRINE HYDROCHLORIDE

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
50090-4727
Requested NDC
50090-4727-01
Package NDCs from labels
50090-4727-8, 50090-4727-2, 50090-4727-9, 50090-4727-6, 50090-4727-0, 50090-4727-7, 50090-4727-3, 50090-4727-4, 50090-4727-1, 50090-4727-01
Manufacturer
A-S Medication Solutions
Effective date
2025-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CYCLOBENZAPRINE HYDROCHLORIDE - A-S Medication SolutionsA-S Medication Solutions2025-08-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-4727-02023-02-07Cyclobenzaprine hydrochloride, USP
50090-4727-12023-02-07Cyclobenzaprine hydrochloride, USP
50090-4727-22023-02-07Cyclobenzaprine hydrochloride, USP
50090-4727-32023-02-07Cyclobenzaprine hydrochloride, USP
50090-4727-42023-02-07Cyclobenzaprine hydrochloride, USP
50090-4727-62023-02-07Cyclobenzaprine hydrochloride, USP
50090-4727-72023-02-07Cyclobenzaprine hydrochloride, USP
50090-4727-82023-02-07Cyclobenzaprine hydrochloride, USP
50090-4727-92023-02-07Cyclobenzaprine hydrochloride, USP
50090-4727-02023-01-30Cyclobenzaprine hydrochloride, USP
50090-4727-12023-01-30Cyclobenzaprine hydrochloride, USP
50090-4727-22023-01-30Cyclobenzaprine hydrochloride, USP
50090-4727-32023-01-30Cyclobenzaprine hydrochloride, USP
50090-4727-42023-01-30Cyclobenzaprine hydrochloride, USP
50090-4727-62023-01-30Cyclobenzaprine hydrochloride, USP
50090-4727-72023-01-30Cyclobenzaprine hydrochloride, USP
50090-4727-82023-01-30Cyclobenzaprine hydrochloride, USP
50090-4727-92023-01-30Cyclobenzaprine hydrochloride, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4727-0CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED1511
50090-4727-1CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED2011
50090-4727-2CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3011
50090-4727-3CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED6011
50090-4727-4CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED10011
50090-4727-6CYCLOBENZAPRINE HYDROCHLORIDE7 in 1 BOTTLETABLET, FILM COATED711
50090-4727-7CYCLOBENZAPRINE HYDROCHLORIDE14 in 1 BOTTLETABLET, FILM COATED1411
50090-4727-8CYCLOBENZAPRINE HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED2111
50090-4727-9CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4727CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 9 package rows20240310_eb908b77-741c-473a-b2e9-4f82167c3088.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4727-0EA - Each50090-4727592557a5-7ef3-48b4-b002-0f67d3e5b04c12024-03-12
50090-4727-1EA - Each50090-472767b2a7b1-2ef7-4c95-a221-222e3c48d1e012022-01-06
50090-4727-2EA - Each50090-4727fbfd61e2-6c81-4e5d-a7bc-6c720e28897e12021-08-05
50090-4727-3EA - Each50090-47277d50ee14-4af4-4d88-9bb3-afc015ef21c412024-03-12
50090-4727-4EA - Each50090-47279fcc94e4-4b6e-4e75-996d-daefd89ff80612024-03-12
50090-4727-6EA - Each50090-4727bb682793-3ca2-431a-b014-42b9e5c0fed512021-04-08
50090-4727-7EA - Each50090-4727ec59fc94-5b59-4371-b4a5-639f0e830ece12024-03-12
50090-4727-8EA - Each50090-472748e65334-2c9c-4299-ae17-06ec5ed2023812024-03-12
50090-4727-9EA - Each50090-4727536b1320-962d-4b41-9795-06582e58a96212024-03-12

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 147 · 2,940 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.e4ed7ad2-cf58-4fdb-bc8c-d89f23b012102026-08-17Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEUnit Dose Solutions, Inc.53bef1ab-55c0-cc52-e063-6394a90a12b32026-08-17Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828348
unii: 0VE05JYS2P
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
TONMYACYCLOBENZAPRINE HYDROCHLORIDETonix Medicines, Inc.6fa59588-ce9b-48cf-8c5f-725a448f85712026-08-14Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDERedpharm Drug58e6d82b-52fd-cca3-e063-6294a90a11042026-08-13Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828348
unii: 0VE05JYS2P

Reported adverse events (FAERS/openFDA)#

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