KETOCONAZOLE by MONTAGE CHEMICALS PRIVATE LIMITED KETOCONAZOLE powder

KETOCONAZOLE by

Drug Labeling and Warnings

KETOCONAZOLE by is a Other medication manufactured, distributed, or labeled by MONTAGE CHEMICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PACKAGE LABEL

Drum No.1

PRODUCT : KETOCONAZOLE USP
BATCH NOS : MT/AP/KTN/2301002
Mfg.Date : JANUARY 2024
Exp.Date : DECEMBER 2027
Nett - Wt. : 25.00 Kgs
Tare - Wt. : 02.90 Kgs
Gross Wt. : 27.90 Kgs
D.L No. : MH-25/KD-722
CONSIGNEE :
Attn. Hari Chreddi
New Horizon Pharma US INC., 1794 Oak Tree
Road, Edison, 08820 New Jersey, United States
Mob.: +1 (646) 932-9939
Through: (AIR TRANSPORT- DOOR DELIVERED)
Mfd. By :
Montage Chemicals Pvt Ltd,
W-38, MIDC Area,
Morivali, Ambernath – (W)
Dist. Thane, MH, India
DUNS No: 862273604
FEI No: 3005537897
NDC: 86203-7102-1 (Prospective)

STORAGE CONDITION-STORE IN A CLEAN AND DRY PLACE, FREE FROM DUST
AND MOISTURE, AT AMBIENT TEMPERATURE

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INGREDIENTS AND APPEARANCE

KETOCONAZOLE 
ketoconazole powder

Product Information
Product Type		Item Code (Source)	NDC: 86203-7102
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	25 kg  in 25 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86203-7102-1	25 kg in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
bulk ingredient		05/13/2024

Labeler - MONTAGE CHEMICALS PRIVATE LIMITED (862273604)

Registrant - MONTAGE CHEMICALS PRIVATE LIMITED (862273604)

Establishment
Name	Address	ID/FEI	Business Operations
MONTAGE CHEMICALS PRIVATE LIMITED		862273604	api manufacture