Doxepin Hydrochloride (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

Doxepin HCl capsules USP, 10 mg
image of Doxepin HCl 10 mg package label
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image of Doxepin HCl 25 mg package label
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image of Doxepin HCl 50 mg package label
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Doxepin HCl capsules USP, 75 mg

image of Doxepin HCl 75 mg package label
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image of Doxepin HCl 100 mg package label
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image of Doxepin HCl 150 mg package label
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DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0062(NDC:49884-218)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
PROPYLENE GLYCOL
Product Characteristics
Color white (White Opaque/Ivory Opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code Par;218
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0062-0 100 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-0062-2 30 CAPSULE (CAPSULE) in 1 BOTTLE None
3 NDC:54868-0062-4 15 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071437 04/24/1996
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-2317(NDC:49884-217)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C ORANGE NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
Product Characteristics
Color brown (Buff Opaque) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code Par;217
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2317-2 60 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-2317-3 30 CAPSULE (CAPSULE) in 1 BOTTLE None
3 NDC:54868-2317-4 100 CAPSULE (CAPSULE) in 1 BOTTLE None
4 NDC:54868-2317-0 10 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071697 01/03/1995
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-1964(NDC:49884-219)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
PROPYLENE GLYCOL
Product Characteristics
Color white (Ivory Opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Par;219
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-1964-2 30 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-1964-3 100 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071595 09/28/1999
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-2552(NDC:49884-220)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN HYDROCHLORIDE 75 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C GREEN NO. 3
PROPYLENE GLYCOL
Product Characteristics
Color green (Bright Light Green Opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Par;220
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2552-0 100 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-2552-2 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071608 06/10/2003
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-2284(NDC:49884-221)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C GREEN NO. 3
GELATIN
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color white (White Opaque) , green (Bright Light Green Opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Par;221
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2284-2 100 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-2284-6 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071422 10/03/1996
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3533(NDC:49884-222)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color white (White Opaque) , blue (Blue Opaque) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code Par;222
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-3533-0 30 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-3533-1 100 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071669 08/01/2007
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 repack, relabel

Revised: 12/2009 Physicians Total Care, Inc.

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