Morphine Sulfate Extended Release (Page 10 of 10)

Package/Label Display Panel – Carton – 30 mg

NDC 68084- 158 -01

Morphine Sulfate     CII
Extended-Release Tablets

30 mg

100 Tablets (10 x 10)               Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Morphine Sulfate USP………………………………………………….30 mg

Usual Dosage: See package insert for full prescribing
information.
Swallow tablets whole. Do not break, crush, dissolve, or
chew.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled Room
Temperature].

DEA Order Form Required

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 42858-802, Rhodes Pharmaceuticals L. P.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

015801 0215801/0419

Package/Label Display Panel – Blister – 30 mg

Morphine Sulfate
Extended-Release      CII Tablet           30 mg

MORPHINE SULFATE EXTENDED RELEASE morphine sulfate tablet, film coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-157(NDC:42858-801) Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 15 mg

Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE FD&C BLUE NO. 2 LACTOSE MONOHYDRATE POLYSORBATE 80

Product Characteristics Color blue Score no score Shape ROUND Size 7mm Flavor Imprint Code ABG;15 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68084-157-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-157-11) 1 NDC:68084-157-11 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-157-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074862 10/21/2013

MORPHINE SULFATE EXTENDED RELEASE morphine sulfate tablet, film coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-158(NDC:42858-802) Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 30 mg

Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE D&C RED NO. 7 FD&C BLUE NO. 1 LACTOSE MONOHYDRATE POLYSORBATE 80

Product Characteristics Color purple (Lavender) Score no score Shape ROUND Size 7mm Flavor Imprint Code ABG;30 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68084-158-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-158-11) 1 NDC:68084-158-11 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-158-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074862 08/27/2013

Labeler — American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Operations
American Health Packaging		929561009	repack (68084-157), repack (68084-158)

Revised: 12/2020 American Health Packaging