CHLORDIAZEPOXIDE HYDROCHLORIDE (Page 5 of 5)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — 5 mg 100ct

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — 10 mg 100ct

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 25 mg 100ct

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CHLORDIAZEPOXIDE HYDROCHLORIDE
chlordiazepoxide hydrochloride capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-564
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORDIAZEPOXIDE HYDROCHLORIDE (CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
TALC
METHYLPARABEN
PROPYLPARABEN
POTASSIUM SORBATE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C GREEN NO. 3
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color GREEN (Green; Yellow) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 564
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42806-564-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085461 08/13/2021
CHLORDIAZEPOXIDE HYDROCHLORIDE
chlordiazepoxide hydrochloride capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-565
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORDIAZEPOXIDE HYDROCHLORIDE (CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
TALC
METHYLPARABEN
PROPYLPARABEN
POTASSIUM SORBATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 3
FD&C GREEN NO. 3
FD&C RED NO. 40
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color GREEN (Green; Black) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 565
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42806-565-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085472 08/13/2021
CHLORDIAZEPOXIDE HYDROCHLORIDE
chlordiazepoxide hydrochloride capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-566
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORDIAZEPOXIDE HYDROCHLORIDE (CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
TALC
METHYLPARABEN
PROPYLPARABEN
POTASSIUM SORBATE
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C BLUE NO. 1
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color GREEN (Green; White) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 566
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42806-566-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085475 08/13/2021
Labeler — Epic Pharma LLC (827915443)
Registrant — Epic Pharma LLC (827915443)
Establishment
Name Address ID/FEI Operations
Epic Pharma LLC 827915443 MANUFACTURE (42806-564), MANUFACTURE (42806-565), MANUFACTURE (42806-566)

Revised: 09/2021 Epic Pharma LLC

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