NDC Code(s) : 68382-761-14, 68382-762-14, 68382-763-14, 68382-764-05, 68382-764-06, 68382-765-05, 68382-765-06
Packager : Zydus Pharmaceuticals USA Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ClarithromycinClarithromycin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-761
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN(UNII: H1250JIK0A)
(CLARITHROMYCIN - UNII:H1250JIK0A) 		CLARITHROMYCIN250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MAGNESIUM STEARATE(UNII: 70097M6I30)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SORBIC ACID(UNII: X045WJ989B)
SORBITAN MONOOLEATE(UNII: 06XEA2VD56)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
VANILLIN(UNII: CHI530446X)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POVIDONE(UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code KT
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-761-1460 in 1 BOTTLE Type 0: Not a Combination Product07/12/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050662 12/07/2011 04/26/2017
ClarithromycinClarithromycin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-762
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN(UNII: H1250JIK0A)
(CLARITHROMYCIN - UNII:H1250JIK0A) 		CLARITHROMYCIN500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SORBIC ACID(UNII: X045WJ989B)
SORBITAN MONOOLEATE(UNII: 06XEA2VD56)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
VANILLIN(UNII: CHI530446X)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POVIDONE(UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code KL
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-762-1460 in 1 BOTTLE Type 0: Not a Combination Product07/12/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050662 12/07/2011 12/03/2017
ClarithromycinClarithromycin TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-763
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN(UNII: H1250JIK0A)
(CLARITHROMYCIN - UNII:H1250JIK0A) 		CLARITHROMYCIN500 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SORBIC ACID(UNII: X045WJ989B)
SORBITAN MONOOLEATE(UNII: 06XEA2VD56)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
VANILLIN(UNII: CHI530446X)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code KJ
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-763-1460 in 1 BOTTLE Type 0: Not a Combination Product03/03/2000
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050775 03/03/2000 10/31/2014
ClarithromycinClarithromycin FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-764
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN(UNII: H1250JIK0A)
(CLARITHROMYCIN - UNII:H1250JIK0A) 		CLARITHROMYCIN125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL(UNII: D5340Y2I9G)
XANTHAN GUM(UNII: TTV12P4NEE)
SUCROSE(UNII: C151H8M554)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POVIDONE(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 809Y72KV36)
Product Characteristics
Color Score
Shape Size
Flavor FRUIT PUNCH Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-764-0550 mL in 1 BOTTLE Type 0: Not a Combination Product07/12/2011
2NDC:68382-764-06100 mL in 1 BOTTLE Type 0: Not a Combination Product07/12/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050698 12/07/2011 09/01/2017
ClarithromycinClarithromycin FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-765
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN(UNII: H1250JIK0A)
(CLARITHROMYCIN - UNII:H1250JIK0A) 		CLARITHROMYCIN250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL(UNII: D5340Y2I9G)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
XANTHAN GUM(UNII: TTV12P4NEE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CARBOMER 1342(UNII: 809Y72KV36)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(UNII: 87Y6436BKR)
POVIDONE(UNII: FZ989GH94E)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color Score
Shape Size
Flavor FRUIT PUNCH Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-765-0550 mL in 1 BOTTLE Type 0: Not a Combination Product07/12/2011
2NDC:68382-765-06100 mL in 1 BOTTLE Type 0: Not a Combination Product07/12/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050698 12/07/2011 08/31/2017

PRINCIPAL DISPLAY PANEL

NDC 68382–761–14

no image available

500 mg 60 ct

ZyGenerics

NDC 68382–762–14

CLARITHROMYCIN TABLETS, USP

500 mg 60 Film-Coated Tablets

Rx only

500 mg 60 ct

ZyGenerics

NDC 68382–764–05

50 mL (when mixed)

Clarithromycin for Oral Suspension, USP

125 mg per 5 mL when reconstituted

Rx only

500 mg 60 ct

ZyGenerics

NDC 68382–765–06

100 mL (when mixed)

Clarithromycin for Oral Suspension, USP

250 mg per 5 mL when reconstituted

Rx only

500 mg 60 ct

NDC 68382–763–14

no image available

500 mg 60 ct