Divalproex Sodium (Page 18 of 18)

PRINCIPAL DISPLAY PANEL — 250 mg

NDC 51079-766-08

Once-Daily Dosing

Divalproex Sodium
Extended-Release
Tablets, USP
250 mg*

Valproic Acid Activity

80 Tablets (10 x 8)

*Each film-coated tablet contains
divalproex sodium, USP equivalent
to 250 mg of valproic acid.

Usual Dosage: See accompanying
prescribing information and
Medication Guide.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-10336R8

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Divalproex Sodium Extended-Release 250 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 500 mg

NDC 51079-767-08

Once-Daily Dosing

Divalproex Sodium
Extended-Release
Tablets, USP
500 mg*

Valproic Acid Activity

80 Tablets (10 x 8)

*Each film-coated tablet contains
divalproex sodium, USP equivalent
to 500 mg of valproic acid.

Usual Dosage: See accompanying
prescribing information and
Medication Guide.

Store at 20° to 25°C (68° to 77°F).[See
USP Controlled Room Temperature.]

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-10337 R9

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Divalproex Sodium Extended-Release 500 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
DIVALPROEX SODIUM divalproex sodium tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-766(NDC:0378-0472)
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
AMMONIA
SILICON DIOXIDE
DIBUTYL SEBACATE
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
OLEIC ACID
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor Imprint Code M;177
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-766-08 80 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-766-01)
1 NDC:51079-766-01 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (51079-766-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077567 02/03/2009
DIVALPROEX SODIUM divalproex sodium tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-767(NDC:0378-0473)
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
AMMONIA
SILICON DIOXIDE
DIBUTYL SEBACATE
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
OLEIC ACID
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white Score no score
Shape OVAL Size 21mm
Flavor Imprint Code M;473
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-767-08 80 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-767-01)
1 NDC:51079-767-01 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (51079-767-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077567 02/03/2009
Labeler — Mylan Institutional Inc. (039615992)

Revised: 11/2019 Mylan Institutional Inc.

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