doxepin by Zydus Lifesciences Limited DOXEPIN tablet

doxepin by

Drug Labeling and Warnings

doxepin by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

MEDICATION GUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1528-3 in bottle of 30 tablets

Doxepin Tablets, 3 mg

Rx only

30 tablets

NDC: 70771-1529-3 in bottle of 30 tablets

Doxepin Tablets, 6 mg

Rx only

30 tablets

INGREDIENTS AND APPEARANCE

DOXEPIN 
doxepin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1528
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D)	DOXEPIN	3 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	BLUE (LIGHT BLUE)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	393
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1528-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2024
2	NDC: 70771-1528-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2024
3	NDC: 70771-1528-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2024
4	NDC: 70771-1528-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2024
5	NDC: 70771-1528-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2024
6	NDC: 70771-1528-4	10 in 1 CARTON	06/30/2024
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202761	06/30/2024

DOXEPIN 
doxepin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1529
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D)	DOXEPIN	6 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	GREEN (LIGHT GREEN)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	394
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1529-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2024
2	NDC: 70771-1529-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2024
3	NDC: 70771-1529-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2024
4	NDC: 70771-1529-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2024
5	NDC: 70771-1529-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2024
6	NDC: 70771-1529-4	10 in 1 CARTON	06/30/2024
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202761	06/30/2024

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (650199482)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1528, 70771-1529) , MANUFACTURE(70771-1528, 70771-1529)