DIVALPROEX SODIUM (Page 14 of 14)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Divalproex Sodium

GENERIC: Divalproex Sodium

DOSAGE: Delayed-Release Tablets

ADMINSTRATION: Oral

NDC: 64679-973-03

STRENGTH: 125 mg

COLOR: White

SHAPE: Round

SCORE: no score

SIZE: 9 mm

IMPRINT: 973

QTY: 30 Tablets

Label
(click image for full-size original)

DRUG: Divalproex Sodium

GENERIC: Divalproex Sodium

DOSAGE: Delayed-Release Tablets

ADMINSTRATION: Oral

NDC: 64679-974-01

STRENGTH: 250 mg

COLOR: White

SHAPE: Oval

SCORE: no score

SIZE: 16 mm

IMPRINT: W974

QTY: 100 Tablets

Label
(click image for full-size original)

DRUG: Divalproex Sodium

GENERIC: Divalproex Sodium

DOSAGE: Delayed-Release Tablets

ADMINSTRATION: Oral

NDC: 64679-975-02

STRENGTH: 500 mg

COLOR: White

SHAPE: Oval

SCORE: no score

SIZE: 19 mm

IMPRINT: W975

QTY: 500 Tablets

Label
(click image for full-size original)
DIVALPROEX SODIUM divalproex sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-973
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIVALPROEX SODIUM (VALPROIC ACID) VALPROIC ACID 125 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
DIMETHICONE
GLYCERYL BEHENATE/EICOSADIOATE
HYPROMELLOSES
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
SILICON DIOXIDE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (White) Score no score
Shape ROUND (Circular) Size 9mm
Flavor Imprint Code 973
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-973-03 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:64679-973-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:64679-973-02 500 TABLET, DELAYED RELEASE in 1 BOTTLE None
4 NDC:64679-973-04 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (64679-973-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077296 07/31/2008
DIVALPROEX SODIUM divalproex sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-974
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIVALPROEX SODIUM (VALPROIC ACID) VALPROIC ACID 250 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
DIMETHICONE
GLYCERYL BEHENATE/EICOSADIOATE
HYPROMELLOSES
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
SILICON DIOXIDE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (White) Score no score
Shape OVAL (Oval shape) Size 16mm
Flavor Imprint Code W974
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-974-03 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:64679-974-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:64679-974-02 500 TABLET, DELAYED RELEASE in 1 BOTTLE None
4 NDC:64679-974-04 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (64679-974-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077296 07/31/2008
DIVALPROEX SODIUM divalproex sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-975
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIVALPROEX SODIUM (VALPROIC ACID) VALPROIC ACID 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
DIMETHICONE
GLYCERYL BEHENATE/EICOSADIOATE
HYPROMELLOSES
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
SILICON DIOXIDE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (White) Score no score
Shape OVAL (Oval shape) Size 19mm
Flavor Imprint Code W975
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-975-03 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:64679-975-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:64679-975-02 500 TABLET, DELAYED RELEASE in 1 BOTTLE None
4 NDC:64679-975-04 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (64679-975-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077296 07/31/2008
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt USA LLC. (170508365)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 916489953 ANALYSIS (64679-973), ANALYSIS (64679-974), ANALYSIS (64679-975), MANUFACTURE (64679-973), MANUFACTURE (64679-974), MANUFACTURE (64679-975), LABEL (64679-973), LABEL (64679-974), LABEL (64679-975), PACK (64679-973), PACK (64679-974), PACK (64679-975)

Revised: 04/2018 Wockhardt USA LLC.

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