Oxybutynin Chloride (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL — 5 MG CONTAINER LABEL — 100’S COUNT

NDC 70954-005 -10 100 Tablets

Oxybutynin Chloride Tablets, USP 5 mg

Novitium Pharma Rx only

container-label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 MG CONTAINER LABEL — 500’S COUNT

NDC 70954-005 -20 500 Tablets

Oxybutynin Chloride Tablets, USP 5 mg

Novitium Pharma Rx only

500
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 MG CONTAINER LABEL — 1000’S COUNT

NDC 70954-005 -30 1000 Tablets

Oxybutynin Chloride Tablets, USP 5 mg

Novitium Pharma Rx only

1000
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PRINCIPAL DISPLAY PANEL — 5 MG BLISTER LABEL

NDC 70954-005- 50 Unit dose blister packages of 100 (10 cards of 10 tablets each)
Oxybutynin Chloride Tablets, USP
5 mg
Novitium Pharma LLC Rx only

Blister Label
(click image for full-size original)
Carton Label
(click image for full-size original)

OXYBUTYNIN CHLORIDE oxybutynin chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-005
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBUTYNIN CHLORIDE (OXYBUTYNIN) OXYBUTYNIN CHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code n005
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70954-005-10 100 TABLET in 1 BOTTLE None
2 NDC:70954-005-20 500 TABLET in 1 BOTTLE None
3 NDC:70954-005-30 1000 TABLET in 1 BOTTLE None
4 NDC:70954-005-50 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70954-005-40)
4 NDC:70954-005-40 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70954-005-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209823 11/15/2017
Labeler — Novitium Pharma LLC (080301870)
Establishment
Name Address ID/FEI Operations
Novitium Pharma LLC 080301870 LABEL (70954-005), MANUFACTURE (70954-005)

Revised: 08/2021 Novitium Pharma LLC

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