NDC Code(s) : 50383-924-93, 50383-930-93
Packager : Akorn Operating Company LLC (dba Akorn)

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

buprenorphine hydrochloridebuprenorphine hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-924
Route of Administration SUBLINGUAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1)
(BUPRENORPHINE - UNII:40D3SCR4GZ) 		BUPRENORPHINE2 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)39.88 mg in 1 1
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MANNITOL(UNII: 3OWL53L36A)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
POVIDONE K30(UNII: U725QWY32X)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50383-924-9330 in 1 BOTTLE Type 0: Not a Combination Product24/09/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090622 09/24/2010 03/31/2025
buprenorphine hydrochloridebuprenorphine hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-930
Route of Administration SUBLINGUAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1)
(BUPRENORPHINE - UNII:40D3SCR4GZ) 		BUPRENORPHINE8 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)37.79 mg in 1 1
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MANNITOL(UNII: 3OWL53L36A)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
POVIDONE K30(UNII: U725QWY32X)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50383-930-9330 in 1 BOTTLE Type 0: Not a Combination Product24/09/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090622 09/24/2010 03/31/2025

LABELER - Akorn Operating Company LLC (dba Akorn)(117696873)

REGISTRANT - Ethypharm Inc(256904426)

PRINCIPAL DISPLAY PANEL

NDC 50383-924-93

30 Tablets

CIII

PHARMACIST: Dispense the Medication Guide to each patient.

Buprenorphine
Sublingual Tablets
2 mg*

Rx only

PRINCIPAL DISPLAY PANEL - 2 mg Sublingual Tablet 30-count Bottle Label



PRINCIPAL DISPLAY PANEL

NDC 50383-930-93

30 Tablets

CIII

PHARMACIST: Dispense the Medication Guide to each patient.

Buprenorphine
Sublingual Tablets
8 mg*

Rx only

PRINCIPAL DISPLAY PANEL - 8 mg Sublingual Tablet 30-count Bottle Label