Metformin Hydrochloride (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 29033-031-06
Metformin Hydrochloride Extended-release Tablets, USP
500 mg
Rx only60 Tablets

NDC 29033-031-06 Metformin hydrochloride extended-release tablets 500 mg/tablet 60 TABLETS Rx only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 29033-032-06
Metformin Hydrochloride Extended-release Tablets, USP
1000 mg
Rx only60 Tablets

NDC 29033-032-06 Metformin hydrochloride extended-release tablets 1,000 mg/tablet 60 TABLETS Rx only
(click image for full-size original)

METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29033-031
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STEARIC ACID
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
OLEIC ACID
ETHYLCELLULOSES
TALC
HYPROMELLOSE 2208 (100000 MPA.S)
POLYETHYLENE GLYCOL 400
MEDIUM-CHAIN TRIGLYCERIDES
POVIDONE
XANTHAN GUM
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code NF5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29033-031-06 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203832 01/02/2018
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29033-032
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 1000 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STEARIC ACID
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
OLEIC ACID
ETHYLCELLULOSES
TALC
HYPROMELLOSE 2208 (100000 MPA.S)
POLYETHYLENE GLYCOL 400
MEDIUM-CHAIN TRIGLYCERIDES
POVIDONE
XANTHAN GUM
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code NF0
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29033-032-06 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203832 01/02/2018
Labeler — Nostrum Laboratories, Inc. (791142354)
Registrant — Nostrum Laboratories, Inc. (791142354)
Establishment
Name Address ID/FEI Operations
Nostrum Laboratories, Inc. 791142354 ANALYSIS (29033-031), ANALYSIS (29033-032), MANUFACTURE (29033-031), MANUFACTURE (29033-032), pack (29033-031), pack (29033-032), label (29033-031), label (29033-032)

Revised: 06/2020 Nostrum Laboratories, Inc.

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