Loperamide Hydrochloride (Page 5 of 5)

HOW SUPPLIED

Loperamide hydrochloride capsules USP, 2 mg are available as:

A light brown opaque body and dark brown opaque capsule, imprinted “TEVA” on the cap and “0311” on the body and packaged in bottles of 15 (NDC 70934-546-15)

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a well-closed container, as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured In Czech Republic By:

Teva Czech Industries, s.r.o.

Opava-Komarov, Czech Republic

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. Q 11/2016

Principal Display Panel

NDC: 70934-546-15

label
(click image for full-size original)
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-546(NDC:0093-0311)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE
GELATIN, UNSPECIFIED
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
STARCH, CORN
MAGNESIUM STEARATE
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color brown (light and dark brown) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code TEVA;0311
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-546-15 15 CAPSULE in 1 BOTTLE, PLASTIC None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073192 02/06/2020
Labeler — Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. dba Northwind Pharmaceuticals 080355546 repack (70934-546)

Revised: 02/2020 Denton Pharma, Inc. dba Northwind Pharmaceuticals

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