Doxepin Hydrochloride (Page 2 of 2)

5059-10 mg Label

10 mg lable
(click image for full-size original)

5060- 25 mg Label

25 mg Lable
(click image for full-size original)

5061-50 mg Label

50 mg Lable
(click image for full-size original)

5062 — 75 mg Label

75 mg Label
(click image for full-size original)

5063 — 100 mg Label

100 mg Label
(click image for full-size original)

DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71921-164
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 50 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
PROPYLENE GLYCOL
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
SILICON DIOXIDE
D&C YELLOW NO. 10
AMMONIA
SHELLAC
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
GELATIN
FERROSOFERRIC OXIDE
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
Product Characteristics
Color white (IVORY/IVORY) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code FPP;164
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71921-164-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213474 05/01/2021
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71921-162
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
AMMONIA
MAGNESIUM STEARATE
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
GELATIN
PROPYLENE GLYCOL
SHELLAC
STARCH, CORN
Product Characteristics
Color white (BUFF/BUFF) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code FPP;162
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71921-162-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213474 05/01/2021
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71921-166
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 100 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
AMMONIA
SHELLAC
GELATIN
PROPYLENE GLYCOL
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
TITANIUM DIOXIDE
POTASSIUM HYDROXIDE
FD&C GREEN NO. 3
FERROSOFERRIC OXIDE
STARCH, CORN
D&C YELLOW NO. 10
Product Characteristics
Color green (LIGHT GREEN) , white (LIGHT WHITE) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code FPP;166
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71921-166-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213474 05/01/2021
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71921-163
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 25 mg
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
GELATIN, UNSPECIFIED
FERROSOFERRIC OXIDE
AMMONIA
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
FD&C YELLOW NO. 6
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
D&C YELLOW NO. 10
POTASSIUM HYDROXIDE
STARCH, CORN
SHELLAC
Product Characteristics
Color white (IVORY/WHITE) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code FPP;163
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71921-163-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213474 05/01/2021
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71921-165
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 75 mg
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
GELATIN
FERROSOFERRIC OXIDE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
FD&C GREEN NO. 3
AMMONIA
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POTASSIUM HYDROXIDE
SILICON DIOXIDE
D&C YELLOW NO. 10
Product Characteristics
Color green (LIGHT GREEN/LIGHT GREEN) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code FPP;165
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71921-165-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213474 05/01/2021
Labeler — Florida Pharmaceutical Products, LLC (084014259)
Registrant — Contract Pharmacal Corp. (057795122)

Revised: 09/2021 Florida Pharmaceutical Products, LLC

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