PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1006-1

Doxycycline Tablets, USP – 50 mg

Rx only

100 Tablets

NDC 70771-1007-1

Doxycycline Tablets, USP – 75 mg

Rx only

100 Tablets

NDC 70771-1008-7

Doxycycline Tablets, USP – 100 mg

Rx only

50 Tablets

NDC 70771-1009-1

Doxycycline Tablets, USP – 150 mg

Rx only

100 Tablets

DOXYCYCLINE
doxycycline tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)	DOXYCYCLINE ANHYDROUS	50 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (PALE YELLOW)	Score	no score
Shape	ROUND (biconvex, beveled edged)	Size	7mm
Flavor		Imprint Code	1121
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1006-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209582	01/11/2018

DOXYCYCLINE
doxycycline tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)	DOXYCYCLINE ANHYDROUS	75 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	ORANGE (CREAMISH ORANGE)	Score	no score
Shape	ROUND (biconvex, beveled edged)	Size	8mm
Flavor		Imprint Code	1122
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1007-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209582	01/11/2018

DOXYCYCLINE
doxycycline tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)	DOXYCYCLINE ANHYDROUS	100 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (LEMON YELLOW TO BUFF COLORED)	Score	no score
Shape	ROUND (biconvex, beveled edged)	Size	9mm
Flavor		Imprint Code	1123
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1008-7	50 in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2018
2	NDC:70771-1008-8	250 in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209582	01/11/2018

DOXYCYCLINE
doxycycline tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)	DOXYCYCLINE ANHYDROUS	150 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	ORANGE (DARK ORANGE TO CREAMISH ORANGE)	Score	2 pieces
Shape	ROUND (biconvex, beveled edged)	Size	11mm
Flavor		Imprint Code	1124
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1009-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2018
2	NDC:70771-1009-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209582	01/11/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1006, 70771-1007, 70771-1008, 70771-1009) , MANUFACTURE(70771-1006, 70771-1007, 70771-1008, 70771-1009)