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
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 7 of 118 · 2,343 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4fbbc5b6-7aac-34e5-e054-00144ff88e88	2026-05-19	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc.	23cc5ff4-f842-4e3e-ac5c-23dbaf7d3914	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM	TITANIUM DIOXIDE AND ZINC OXIDE	SICOS ET CIE	c688f8e6-2cd2-40db-b03f-90fd74c2d89c	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	7df9dbd2-7db9-4961-819d-e93d14a065c3	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	20efd5fa-3077-4fd4-82d0-ddca946e4528	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	OCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	51c353cb-94c4-e110-e063-6394a90a497e	2026-05-14	Warnings	Exact identifier unii: 15FIX9V2JP
blink tears	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	f1d07347-086f-43b2-aa5f-910764fc666e	2026-05-13	Warnings	Exact identifier unii: B697894SGQ
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	aedde765-931f-430e-9fc3-d87bde2b78cd	2026-05-12	Warnings	Exact identifier unii: 15FIX9V2JP
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	417305d7-d32e-4bc9-8f77-0a42b6bdecf5	2026-05-12	Warnings	Exact identifier unii: 15FIX9V2JP
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Bella Medical Products LLC	518f69fc-fd39-8195-e063-6294a90a3fdd	2026-05-11	Warnings	Exact identifier unii: 15FIX9V2JP
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral Sunscreen	RADICAL RESCUE SPF 30 MINERAL SUNSCREEN	ProTransit, Inc.	38e0139c-bb87-55ba-e063-6294a90a82ee	2026-05-11	Warnings	Exact identifier unii: 15FIX9V2JP
EELHOE Sunscreen	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	5196ccb0-4515-7e40-e063-6394a90a09bd	2026-05-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	bb65c8d7-318f-4d52-9d74-ca22ce389638	2026-05-07	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	67b90f00-4c82-40cd-af96-f8dedf95f8af	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7a2bd17d-0ea7-4326-9939-a747869c01d2	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a396c0eb-f91f-4732-9c20-6b25aa0634b7	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	18b21fba-f6ee-4ac5-a536-096716f51da0	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	13c34bba-f939-4aa7-9457-9d6025902e06	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d12905b6-97aa-429a-8800-23856fe31f06	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	43599d17-81f4-4c6e-b6bd-d1e700b668ee	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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