Metoprolol Succinate: Package Insert and Label Information (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 200 mg Tablet Bottle Label

NDC 70436-167-01

Metoprolol Succinate Extended-Release Tablets, USP

200 mg, 100 Tablets

200mg-100ct
(click image for full-size original)

NDC 70436-167-02

Metoprolol Succinate Extended-Release Tablets, USP

200 mg, 500 Tablets

200mg-500ct
(click image for full-size original)

NDC 70436-167-03

Metoprolol Succinate Extended-Release Tablets, USP

200 mg, 1000 Tablets

200mg-1000ct
(click image for full-size original)
METOPROLOL SUCCINATE
metoprolol succinate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-166
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
ETHYLCELLULOSES
HYPROMELLOSES
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 6000
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code YH;163
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-166-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70436-166-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70436-166-03 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213854 04/29/2021
METOPROLOL SUCCINATE
metoprolol succinate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-167
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
ETHYLCELLULOSES
HYPROMELLOSES
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 6000
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 17mm
Flavor Imprint Code YH;161
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-167-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70436-167-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70436-167-03 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213854 04/29/2021
Labeler — Slate Run Pharmaceuticals, LLC (039452765)
Registrant — Yichang Humanwell Pharmaceutical Co., Ltd (527225336)
Establishment
Name Address ID/FEI Operations
Yichang Humanwell Oral Solid Dosge Plant 421371958 manufacture (70436-166), manufacture (70436-167)

Revised: 04/2021 Slate Run Pharmaceuticals, LLC

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