NDC Code(s) : 42858-501-03, 42858-502-03
Packager : Rhodes Pharmaceuticals L.P.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BUPRENORPHINEBUPRENORPHINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-501
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
Lactose monohydrate(UNII: EWQ57Q8I5X)
Povidone K30(UNII: U725QWY32X)
Anhydrous Citric Acid(UNII: XF417D3PSL)
Trisodium Citrate Dihydrate(UNII: B22547B95K)
Starch, Corn(UNII: O8232NY3SJ)
Mannitol(UNII: 3OWL53L36A)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
Magnesium Stearate(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code RP;b2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42858-501-0330 in 1 BOTTLE Type 0: Not a Combination Product25/10/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207276 10/25/2017
BUPRENORPHINEBUPRENORPHINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-502
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
Lactose monohydrate(UNII: EWQ57Q8I5X)
Povidone K30(UNII: U725QWY32X)
Anhydrous Citric Acid(UNII: XF417D3PSL)
Trisodium Citrate Dihydrate(UNII: B22547B95K)
Starch, Corn(UNII: O8232NY3SJ)
Mannitol(UNII: 3OWL53L36A)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
Magnesium Stearate(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code RP;b8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42858-502-0330 in 1 BOTTLE Type 0: Not a Combination Product25/10/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207276 10/25/2017

LABELER - Rhodes Pharmaceuticals L.P.(831928986)

Establishment
Name Address ID/FEI Business Operations
Purdue Pharmaceuticals L.P. 132080875 MANUFACTURE(42858-501, 42858-502)

PRINCIPAL DISPLAY PANEL

NDC 42858-501-03

Buprenorphine

Sublingual
Tablets
CIII

2 mg

Rx only

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Children who accidently take
buprenorphine will need emergency
medical care. Keep out of the reach
of children.

30 Tablets

PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 42858-502-03

Buprenorphine

Sublingual
Tablets
CIII

8 mg

Rx only

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Children who accidently take
buprenorphine will need emergency
medical care. Keep out of the reach
of children.

30 Tablets

PRINCIPAL DISPLAY PANEL - 8 mg Tablet Bottle Label