TRAMADOL HYDROCHLORIDE (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS

Rx Only

100 mg

NDC 68180-697-06

30 TABLETS

TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS

Rx Only

200 mg

NDC 68180-698-06

30 TABLETS

TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS

Rx Only

300 mg

NDC 68180-699-06

30 TABLETS

TRAMADOL HYDROCHLORIDE tramadol hydrochloride tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-697 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 100 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE DIBUTYL SEBACATE ETHYLCELLULOSES FERROSOFERRIC OXIDE POVIDONE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM STEARYL FUMARATE

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (biconvex) Size 6mm Flavor Imprint Code L010 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-697-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68180-697-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68180-697-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200503 08/19/2014

TRAMADOL HYDROCHLORIDE tramadol hydrochloride tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-698 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 200 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE DIBUTYL SEBACATE ETHYLCELLULOSES FERROSOFERRIC OXIDE POVIDONE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM STEARYL FUMARATE

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (biconvex) Size 9mm Flavor Imprint Code L011 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-698-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68180-698-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68180-698-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200503 08/19/2014

TRAMADOL HYDROCHLORIDE tramadol hydrochloride tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-699 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 300 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE DIBUTYL SEBACATE ETHYLCELLULOSES FERROSOFERRIC OXIDE POVIDONE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM STEARYL FUMARATE

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (biconvex) Size 10mm Flavor Imprint Code L012 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-699-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68180-699-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200503 08/19/2014

Labeler — Lupin Pharmaceuticals, Inc. (089153071)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		863645527	MANUFACTURE (68180-697), MANUFACTURE (68180-698), MANUFACTURE (68180-699), PACK (68180-697), PACK (68180-698), PACK (68180-699)

Revised: 09/2021 Lupin Pharmaceuticals, Inc.