Label: COMPRESSO MF 95P powder
-
NDC Code(s):
62207-400-12,
62207-400-13,
62207-711-00,
62207-711-01, view more62207-711-02, 62207-711-03, 62207-711-04, 62207-711-11, 62207-711-12, 62207-711-13, 62207-711-14, 62207-711-16
- Packager: Granules India Limited
- Category: BULK INGREDIENT
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated May 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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 powderProduct 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 powderProduct 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)