DOXYCYCLINE HYCLATE tablet

Doxycycline hyclate by

Drug Labeling and Warnings

Doxycycline hyclate 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1104-7

Doxycycline Hyclate Tablets, 100 mg

Rx only

50 tablets

INGREDIENTS AND APPEARANCE

DOXYCYCLINE HYCLATE 
doxycycline hyclate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1104
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)	DOXYCYCLINE ANHYDROUS	100 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (BEIGE COLORED)	Score	no score
Shape	ROUND (BICONVEX)	Size	9mm
Flavor		Imprint Code	D77
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1104-7	50 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2018
2	NDC: 70771-1104-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2018
3	NDC: 70771-1104-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2018
4	NDC: 70771-1104-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2018
5	NDC: 70771-1104-4	10 in 1 CARTON	04/02/2018
5	NDC: 70771-1104-2	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	ANDA207773	04/02/2018

Labeler - Cadila Healthcare Limited (918596198)

Registrant - Cadila Healthcare Limited (863362789)

Establishment
Name	Address	ID/FEI	Business Operations
Cadila Healthcare Limited		863362789	ANALYSIS(70771-1104) , MANUFACTURE(70771-1104)