NDC 63459-700-02 - 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: 63459-700-02
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
Label	Manufacturer	Effective date	Type
AMRIX - Cephalon, LLC	Cephalon, LLC	2024-04-30	HUMAN PRESCRIPTION DRUG LABEL
AMRIX - A-S Medication Solutions	A-S Medication Solutions	2017-11-08	HUMAN PRESCRIPTION DRUG LABEL
AMRIX ® (Cyclobenzaprine Hydrochloride Extended-Release Capsules)	Physicians Total Care, Inc.	2012-08-06	HUMAN PRESCRIPTION DRUG LABEL
Amrix - STAT RX USA LLC	STAT RX USA LLC	2011-02-18	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63459-700-02	AMRIX	2 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	2	31
63459-700-11	AMRIX	1 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	1	31
63459-700-15	AMRIX	10 in 1 CARTON	CAPSULE, EXTENDED RELEASE	10	31
63459-700-22	AMRIX	5 in 1 CARTON	CAPSULE, EXTENDED RELEASE	5	31
63459-700-60	AMRIX	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63459-700	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, LLC]	31	Current NDC, Legacy NDC, 5 package rows	20250502_3902123b-1365-ac3c-0934-afff9eeeb1bd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63459-700-60	EA - Each	63459-700	49653a46-563f-4817-b2a9-9a99120f6dd5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
ETHYLCELLULOSE (10 MPA.S)	INACTIVE INGREDIENT	3DYK7UYZ62	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, INCORPORATED]	12
cyclobenzaprine hydrochloride	ACTIVE INGREDIENT	0VE05JYS2P	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
Cyclobenzaprine	ACTIVE MOIETY	69O5WQQ5TI	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
ETHYLCELLULOSE (10 MPA.S)	INACTIVE INGREDIENT	3DYK7UYZ62	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMRIX (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 1 of 119 · 2,376 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier unii: 15FIX9V2JP
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	5d536e88-62be-45bd-bd09-0efc53fe12b9	2026-09-09	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Sportpharm LLC	71185d15-3fd7-42b7-83a6-8357e3aaef43	2026-09-05	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
Dr.Harry EYES PROTECTION	POLYETHYLENE GLYCOL 400 1% EYES PROTECTION	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5a9fe033-89d3-da62-e063-6294a90a4503	2026-09-03	Warnings	Exact identifier unii: B697894SGQ
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	37056cab-953e-43ba-9b4c-163a739a52f7	2026-09-02	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	30e61110-5bc8-4134-8456-538558479735	2026-09-01	Warnings, Adverse reactions	Exact identifier application number: NDA021777 rxcui: 828358 unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	ba659e1a-0091-45f6-b418-f4f36c9a2c79	2026-08-31	Warnings, Adverse reactions	Exact identifier rxcui: 828358 unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	3175d24d-e8a0-4f14-bed9-a60ad59ac7e7	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: NDA021777 rxcui: 828353 unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	903e3a5a-7c58-b70d-e053-2a95a90a6f9d	2026-08-27	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier unii: 15FIX9V2JP
Q Skin Science	SUNSCREEN	International Cosmeceuticals, Inc	59e4c3d0-ee4c-2350-e063-6394a90ac9d2	2026-08-25	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	e4ed7ad2-cf58-4fdb-bc8c-d89f23b01210	2026-08-17	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	HAMBLIN DERMATOLOGY	5942e64c-416e-7525-e063-6394a90a2839	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Protect Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Opal Day Spa	5943413a-48e1-0bdf-e063-6294a90a2fff	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	MedSpa By Beauty Bar LLC	5943ba3d-688e-9e9c-e063-6294a90afa9a	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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