FDA.reportPublic FDA data

AMRIX

Product NDC
63459-700
11-digit product format
634590700
Labeler code
63459
Product ID
63459-700_ff33280b-7ccc-4a2e-bafd-cbc89cb1cee2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Cephalon, LLC
Application
NDA021777
Marketing category
NDA
Marketing start
2007-10-02
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMRIX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828353, 828355, 828358, 828359

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828359Amrix 15 MG 24HR Extended Release Oral CapsulePSN3902123b-1365-ac3c-0934-afff9eeeb1bd31
828355Amrix 30 MG 24HR Extended Release Oral CapsulePSN3902123b-1365-ac3c-0934-afff9eeeb1bd31
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN3902123b-1365-ac3c-0934-afff9eeeb1bd31
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSN3902123b-1365-ac3c-0934-afff9eeeb1bd31
82835924 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule [Amrix]SBD3902123b-1365-ac3c-0934-afff9eeeb1bd31
82835524 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral Capsule [Amrix]SBD3902123b-1365-ac3c-0934-afff9eeeb1bd31
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD3902123b-1365-ac3c-0934-afff9eeeb1bd31
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCD3902123b-1365-ac3c-0934-afff9eeeb1bd31
82835924 HR Amrix 15 MG Extended Release Oral CapsuleSY3902123b-1365-ac3c-0934-afff9eeeb1bd31
82835524 HR Amrix 30 MG Extended Release Oral CapsuleSY3902123b-1365-ac3c-0934-afff9eeeb1bd31
828359Amrix 15 MG 24 HR Extended Release Oral CapsuleSY3902123b-1365-ac3c-0934-afff9eeeb1bd31
828355Amrix 30 MG 24 HR Extended Release Oral CapsuleSY3902123b-1365-ac3c-0934-afff9eeeb1bd31
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY3902123b-1365-ac3c-0934-afff9eeeb1bd31
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY3902123b-1365-ac3c-0934-afff9eeeb1bd31
828359Amrix 15 MG 24HR Extended Release Oral CapsulePSNc18058a0-9c69-49cf-8454-db3b984278083
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNc18058a0-9c69-49cf-8454-db3b984278083
82835924 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule [Amrix]SBDc18058a0-9c69-49cf-8454-db3b984278083
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDc18058a0-9c69-49cf-8454-db3b984278083
82835924 HR Amrix 15 MG Extended Release Oral CapsuleSYc18058a0-9c69-49cf-8454-db3b984278083
828359Amrix 15 MG 24 HR Extended Release Oral CapsuleSYc18058a0-9c69-49cf-8454-db3b984278083
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYc18058a0-9c69-49cf-8454-db3b984278083
828359Amrix 15 MG 24HR Extended Release Oral CapsulePSNb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
828355Amrix 30 MG 24HR Extended Release Oral CapsulePSNb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSNb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
82835924 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule [Amrix]SBDb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
82835524 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral Capsule [Amrix]SBDb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCDb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
82835924 HR Amrix 15 MG Extended Release Oral CapsuleSYb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
82835524 HR Amrix 30 MG Extended Release Oral CapsuleSYb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
828359Amrix 15 MG 24 HR Extended Release Oral CapsuleSYb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
828355Amrix 30 MG 24 HR Extended Release Oral CapsuleSYb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSYb8ca1d80-6ea9-4a3f-ab06-beedf845de8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63459-700-02634590700022 in 1 BLISTER PACKHistorical
63459-700-11634590700111 in 1 BLISTER PACKHistorical
63459-700-156345907001510 in 1 CARTONHistorical
63459-700-22634590700225 in 1 CARTONHistorical
63459-700-606345907006060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63459-700-60) 2007-10-020000-00-00NoNoCurrent