NDC Code(s) : 62207-188-51, 62207-188-49, 62207-183-51, 62207-183-34, 62207-183-87, 62207-183-49, 62207-183-97, 62207-183-35
Packager : Granules India Limited

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACETAMINOPHENACETAMINOPHEN TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-188
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE K30(UNII: U725QWY32X)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN(UNII: AG9B65PV6B)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code G650
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62207-188-511 in 1 CARTON 18/04/2019
110 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:62207-188-491000 in 1 BOTTLE Type 0: Not a Combination Product18/04/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211544 04/18/2019
ACETAMINOPHENACETAMINOPHEN TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-183
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE K30(UNII: U725QWY32X)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN(UNII: AG9B65PV6B)
STEARIC ACID(UNII: 4ELV7Z65AP)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(UNII: 8136Y38GY5)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code G650
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62207-183-511 in 1 CARTON 18/04/2019
110 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:62207-183-341 in 1 BOX 30/06/2019
25 in 1 POUCH Type 0: Not a Combination Product
3NDC:62207-183-871 in 1 BOX 30/06/2019
31 in 1 POUCH Type 0: Not a Combination Product
4NDC:62207-183-491000 in 1 BOTTLE Type 0: Not a Combination Product18/04/2019
5NDC:62207-183-9740000 in 1 DRUM Type 0: Not a Combination Product25/03/2021
6NDC:62207-183-356 in 1 BOX 05/04/2024
63000 in 1 POUCH Type 0: Not a Combination Product25/03/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211544 04/18/2019

LABELER - Granules India Limited(915000087)

REGISTRANT - Granules India Limited(915000087)

PRINCIPAL DISPLAY PANEL

62207-183-97

62207-183-97

62207-183-97

62207-183-97

62207-183-97

62207-183-97

62207-183-97

62207-183-97

62207-183-97

62207-183-97