Dantrolene Sodium (Page 4 of 4)

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.

Dispense in a tightly-closed, light-resistant container (USP).

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLCBridgewater, NJ 08807

Rev. 10-2020-00

PRINCIPAL DISPLAY PANEL — 25 mg-100ct Bottle Label

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PRINCIPAL DISPLAY PANEL — 50 mg-100ct Bottle Label

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PRINCIPAL DISPLAY PANEL — 100 mg-100 ct Bottle Label

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DANTROLENE SODIUM dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-4411
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (DANTROLENE) DANTROLENE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
D&C YELLOW NO. 10
FD&C GREEN NO. 3
Product Characteristics
Color yellow (yellow opaque) , green (light green opaque) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code G441
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-4411-01 100 CAPSULE in 1 BOTTLE None
2 NDC:0115-4411-02 500 CAPSULE in 1 BOTTLE None
3 NDC:0115-4411-03 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076856 03/01/2005
DANTROLENE SODIUM dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-4422
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (DANTROLENE) DANTROLENE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 1
Product Characteristics
Color yellow (yellow opaque) , blue (light blue opaque) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code G442
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-4422-01 100 CAPSULE in 1 BOTTLE None
2 NDC:0115-4422-02 500 CAPSULE in 1 BOTTLE None
3 NDC:0115-4422-03 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076856 03/01/2005
DANTROLENE SODIUM dantrolene sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-4433
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (DANTROLENE) DANTROLENE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C RED NO. 40
FD&C YELLOW NO. 6
Product Characteristics
Color yellow (yellow opaque) , red (reddish orange opaque) , orange (reddish orange opaque) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code G443
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-4433-01 100 CAPSULE in 1 BOTTLE None
2 NDC:0115-4433-02 500 CAPSULE in 1 BOTTLE None
3 NDC:0115-4433-03 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076856 03/01/2005
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)

Revised: 12/2023 Amneal Pharmaceuticals of New York LLC

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