CARBAMAZEPINE (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

——PRINCIPAL DISPLAY PANEL — 100mg——

Rising® NDC 16571-680-01

Carbamazepine
Extended-Release Tablets, USP

100 mg
Carbamazepine Extended-Release Tablets must be
swallowed whole and never crushed or chewed.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

100 Tablets Rx only

100mg
(click image for full-size original)

——PRINCIPAL DISPLAY PANEL — 200mg——

Rising® NDC 16571-681-01

Carbamazepine
Extended-Release Tablets, USP

200 mg
Carbamazepine Extended-Release Tablets must be
swallowed whole and never crushed or chewed.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

100 Tablets Rx only

200mg
(click image for full-size original)

——PRINCIPAL DISPLAY PANEL — 400mg——

Rising® NDC 16571-682-01

Carbamazepine
Extended-Release Tablets, USP

400 mg
Carbamazepine Extended-Release Tablets must be
swallowed whole and never crushed or chewed.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

100 Tablets Rx only

400mg
(click image for full-size original)

CARBAMAZEPINE carbamazepine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16571-680
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 100 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
HYDROXYETHYL CELLULOSE, UNSPECIFIED
MANNITOL
DEXTRATES
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
CELLULOSE ACETATE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
FERRIC OXIDE YELLOW
SHELLAC
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 8mm
Flavor Imprint Code P100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16571-680-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211623 04/24/2020
CARBAMAZEPINE carbamazepine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16571-681
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 200 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
HYDROXYETHYL CELLULOSE, UNSPECIFIED
MANNITOL
DEXTRATES
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
CELLULOSE ACETATE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
FERRIC OXIDE RED
TITANIUM DIOXIDE
SHELLAC
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10mm
Flavor Imprint Code P200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16571-681-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211623 04/24/2020
CARBAMAZEPINE carbamazepine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16571-682
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 400 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
HYDROXYETHYL CELLULOSE, UNSPECIFIED
MANNITOL
DEXTRATES
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
CELLULOSE ACETATE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
SHELLAC
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 12mm
Flavor Imprint Code P400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16571-682-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211623 04/24/2020
Labeler — Rising Pharma Holdings, Inc. (835513529)
Registrant — Unique Pharmaceutical Laboratories (917165052)
Establishment
Name Address ID/FEI Operations
Unique Pharmaceutical Laboratories 650434645 ANALYSIS (16571-680), ANALYSIS (16571-681), ANALYSIS (16571-682), MANUFACTURE (16571-680), MANUFACTURE (16571-681), MANUFACTURE (16571-682)

Revised: 09/2020 Rising Pharma Holdings, Inc.

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