NDC 63459-700-11 - AMRIX

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
63459-700
Requested NDC
63459-700-11
Package NDCs from labels
63459-700-60, 63459-700-11, 63459-700-15, 63459-700-02, 63459-700-22
Manufacturer
Cephalon, LLC
Effective date
2024-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMRIX - Cephalon, LLCCephalon, LLC2024-04-30HUMAN PRESCRIPTION DRUG LABEL
AMRIX - A-S Medication SolutionsA-S Medication Solutions2017-11-08HUMAN PRESCRIPTION DRUG LABEL
AMRIX ® (Cyclobenzaprine Hydrochloride Extended-Release Capsules)Physicians Total Care, Inc.2012-08-06HUMAN PRESCRIPTION DRUG LABEL
Amrix - STAT RX USA LLCSTAT RX USA LLC2011-02-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63459-700-02AMRIX2 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE231
63459-700-11AMRIX1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE131
63459-700-15AMRIX10 in 1 CARTONCAPSULE, EXTENDED RELEASE1031
63459-700-22AMRIX5 in 1 CARTONCAPSULE, EXTENDED RELEASE531
63459-700-60AMRIX60 in 1 BOTTLECAPSULE, EXTENDED RELEASE6031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-700AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, LLC]31Current NDC, Legacy NDC, 5 package rows20250502_3902123b-1365-ac3c-0934-afff9eeeb1bd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-700-60EA - Each63459-70049653a46-563f-4817-b2a9-9a99120f6dd512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TIAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
GELATININACTIVE INGREDIENT2G86QN327LAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
SUCROSEINACTIVE INGREDIENTC151H8M554AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]12
cyclobenzaprine hydrochlorideACTIVE INGREDIENT0VE05JYS2PAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
CyclobenzaprineACTIVE MOIETY69O5WQQ5TIAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TIAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]1

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 9 of 118 · 2,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.1d9e34cc-eee9-4147-abf8-c810a80e39d22026-05-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPae3a3f5c-fb64-4a43-be88-a2fc7c298ac12026-05-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: B697894SGQ
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECoupler LLC5023b8a5-c9df-84a4-e063-6294a90a96062026-04-23Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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