DOXYCYCLINE HYCLATE tablet, delayed release
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]
- SPL UNCLASSIFIED SECTION
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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
NDC: 70771-1588-6 in bottle of 60 tablets
Doxycycline Hyclate Delayed-release Tablets USP, 100 mg
Rx only
60 tablets
NDC: 70771-1589-6 in bottle of 60 tablets
Doxycycline Hyclate Delayed-release Tablets USP, 150 mg
Rx only
60 tablets
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INGREDIENTS AND APPEARANCE
DOXYCYCLINE HYCLATE
doxycycline hyclate tablet, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1587 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 75 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape OVAL (OVAL) Size 16mm Flavor Imprint Code 70;8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1587-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2018 2 NDC: 70771-1587-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2018 3 NDC: 70771-1587-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2018 4 NDC: 70771-1587-4 10 in 1 CARTON 12/21/2018 4 NDC: 70771-1587-2 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 ANDA206772 12/21/2018 DOXYCYCLINE HYCLATE
doxycycline hyclate tablet, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1588 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) 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 Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape OVAL (OVAL) Size 18mm Flavor Imprint Code 70;9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1588-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2018 2 NDC: 70771-1588-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2018 3 NDC: 70771-1588-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2018 4 NDC: 70771-1588-4 10 in 1 CARTON 12/21/2018 4 NDC: 70771-1588-2 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 ANDA206772 12/21/2018 DOXYCYCLINE HYCLATE
doxycycline hyclate tablet, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1589 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 150 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (WHITE TO OFF-WHITE) Score 3 pieces Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 7;1;0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1589-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2018 2 NDC: 70771-1589-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2018 3 NDC: 70771-1589-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2018 4 NDC: 70771-1589-4 10 in 1 CARTON 12/21/2018 4 NDC: 70771-1589-2 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 ANDA206772 12/21/2018 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1587, 70771-1588, 70771-1589) , MANUFACTURE(70771-1587, 70771-1588, 70771-1589)
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