Compresso MF 95P by Granules India Limited COMPRESSO MF 95P powder

Compresso MF 95P by

Drug Labeling and Warnings

Compresso MF 95P by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

COMPRESSO MF 95 P

(Directly compressible granules containing Metformin HCl USP/Ph.Eur. - 95%)

SPECIMEN LABEL

Batch No.:			Drum No.:
Mfg. Dt.:			Tare Wt.:
Exp. Dt.:			Net Wt.:
Mfg. Lic. No.:		37/RR/AP/2003/F/R	Gross Wt.:
Storage:		Preserve in well closed containers. Store between 15 – 30°C
Caution		For Manufacturing, Processing, or Repacking only.
GIL / PL / 036	Manufactured in India by:Granules India LimitedPlot No. 160/A, 161/E, Gagillapur VillageQutbullapur Mandal, Ranga Reddy Dt – 500 043, AP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COMPRESSO MF 95P 
compresso mf 95p powder

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-711
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	95 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
POVIDONE K90 (UNII: RDH86HJV5Z)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-711-00	5000000 mg in 1 BAG	10/24/2013
2	NDC: 62207-711-01	10000000 mg in 1 BAG	10/24/2013
3	NDC: 62207-711-02	25000000 mg in 1 BAG	10/24/2013
4	NDC: 62207-711-03	40000000 mg in 1 BAG	10/24/2013
5	NDC: 62207-711-04	50000000 mg in 1 BAG	10/24/2013
6	NDC: 62207-711-11	25000000 mg in 1 BAG	10/24/2013
7	NDC: 62207-711-12	40000000 mg in 1 BAG	10/24/2013
8	NDC: 62207-711-13	50000000 mg in 1 BAG	10/24/2013
9	NDC: 62207-711-14	60000000 mg in 1 BAG	10/24/2013
10	NDC: 62207-711-16	100000000 mg in 1 BAG	10/24/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		10/24/2013

COMPRESSO MF 95P 
compresso mf 95p powder

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-400

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	95 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
POVIDONE K90 (UNII: RDH86HJV5Z)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-400-12	40000000 mg in 1 DRUM	08/17/2017
2	NDC: 62207-400-13	50000000 mg in 1 DRUM	05/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/17/2017

Labeler - Granules India Limited (915000087)

Registrant - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(62207-711, 62207-400) , analysis(62207-711)