NDC Code(s) : 24979-035-04, 24979-036-04
Packager : TWi Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-035
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOBENZAPRINE HYDROCHLORIDE(UNII: 0VE05JYS2P)
(CYCLOBENZAPRINE - UNII:69O5WQQ5TI) 		CYCLOBENZAPRINE HYDROCHLORIDE15 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ALCOHOL (UNII: 3K9958V90M)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (1200000 WAMW) (UNII: U3JF91U133)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
SHELLAC(UNII: 46N107B71O)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
METHYL ALCOHOL(UNII: Y4S76JWI15)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color ORANGE (Dark Orange Opaque Cap; Red Opaque Body) Score no score
Shape capsule Size 14 mm
Flavor Imprint Code T035
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-035-0460 in 1 BOTTLE Type 0: Not a Combination Product03/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091281 03/01/2019
Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-036
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOBENZAPRINE HYDROCHLORIDE(UNII: 0VE05JYS2P)
(CYCLOBENZAPRINE - UNII:69O5WQQ5TI) 		CYCLOBENZAPRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ALCOHOL(UNII: 3K9958V90M)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (1200000 WAMW)(UNII: U3JF91U133)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
SHELLAC(UNII: 46N107B71O)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
METHYL ALCOHOL(UNII: Y4S76JWI15)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color orange (Orange Opaque Cap; White Opaque Body) Score no score
Shape capsule Size 16 mm
Flavor Imprint Code T036
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-036-0460 in 1 BOTTLE Type 0: Not a Combination Product03/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091281 03/01/2019

LABELER - TWi Pharmaceuticals, Inc.(658402052)

Establishment
Name Address ID/FEI Business Operations
TWi Pharmaceuticals, Inc. Zhongli Plant 658863394 analysis(24979-035, 24979-036), manufacture(24979-035, 24979-036), pack(24979-035, 24979-036)

Establishment
Name Address ID/FEI Business Operations
TWi Pharmaceuticals, Inc. Zhongli Plant Building II 658869462 manufacture(24979-035, 24979-036), analysis(24979-035, 24979-036), pack(24979-035, 24979-036)

Establishment
Name Address ID/FEI Business Operations
BORA PHARMACEUTICAL LABORATORIES INC. 656139511 pack(24979-035, 24979-036)

PRINCIPAL DISPLAY PANEL

NDC 63459-700-60
amrix® (Cyclobenzaprine Hydrochloride Extended-Release Capsules)
15 mg
 TEVA Rx ONLY
60 Capsules

15 mg label

PRINCIPAL DISPLAY PANEL

NDC 63459-701-60
amrix® (Cyclobenzaprine Hydrochloride Extended-Release Capsules)
30 mg
 TEVA Rx ONLY
 60 Capsules

30mg label