Doxycycline Hyclate Delayed-release Tablets, USP

Doxycycline Hyclate by

Drug Labeling and Warnings

Doxycycline Hyclate by is a Prescription medication manufactured, distributed, or labeled by Cadila Healthcare Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOXYCYCLINE HYCLATE- doxycycline hyclate tablet, delayed release 
Zydus Lifesciences Limited

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Doxycycline Hyclate Delayed-release Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1587-6 in bottle of 60 tablets

Doxycycline Hyclate Delayed-release Tablets USP, 75 mg

Rx only

60 tablets

75 mg label

NDC: 70771-1588-6 in bottle of 60 tablets

Doxycycline Hyclate Delayed-release Tablets USP, 100 mg

Rx only

60 tablets

100 mg label

NDC: 70771-1589-6 in bottle of 60 tablets

Doxycycline Hyclate Delayed-release Tablets USP, 150 mg

Rx only

60 tablets

150 mg label
DOXYCYCLINE HYCLATE 
doxycycline hyclate tablet, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70771-1587
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS75 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size16mm
FlavorImprint Code 70;8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70771-1587-660 in 1 BOTTLE; Type 0: Not a Combination Product12/21/201803/25/2025
2NDC: 70771-1587-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/21/201803/25/2025
3NDC: 70771-1587-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/21/201803/25/2025
4NDC: 70771-1587-410 in 1 CARTON12/21/201803/25/2025
4NDC: 70771-1587-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20677212/21/201804/07/2025
DOXYCYCLINE HYCLATE 
doxycycline hyclate tablet, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70771-1588
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS100 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size18mm
FlavorImprint Code 70;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70771-1588-660 in 1 BOTTLE; Type 0: Not a Combination Product12/21/201803/25/2025
2NDC: 70771-1588-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/21/201803/25/2025
3NDC: 70771-1588-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/21/201803/25/2025
4NDC: 70771-1588-410 in 1 CARTON12/21/201803/25/2025
4NDC: 70771-1588-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20677212/21/201804/07/2025
DOXYCYCLINE HYCLATE 
doxycycline hyclate tablet, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70771-1589
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS150 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score3 pieces
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 7;1;0
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70771-1589-660 in 1 BOTTLE; Type 0: Not a Combination Product12/21/201803/25/2025
2NDC: 70771-1589-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/21/201803/25/2025
3NDC: 70771-1589-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/21/201803/25/2025
4NDC: 70771-1589-410 in 1 CARTON12/21/201803/25/2025
4NDC: 70771-1589-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20677212/21/201804/07/2025
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1587, 70771-1588, 70771-1589) , MANUFACTURE(70771-1587, 70771-1588, 70771-1589)

Revised: 4/2025
Document Id: 3682c645-5409-426b-84e7-ce4e4d0161fb
Set id: ee9f9d92-de7f-4572-8847-225267e1b147
Version: 4
Effective Time: 20250407