Naproxen (Page 8 of 8)

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NAPROXEN
naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-049(NDC:68462-189)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naproxen (Naproxen) Naproxen 375 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
POVIDONE
MAGNESIUM STEARATE
Product Characteristics
Color orange (Light orange) Score no score
Shape OVAL (Bi-Convex) Size 14mm
Flavor Imprint Code G;32;375
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49999-049-60 60 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:49999-049-10 10 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:49999-049-20 20 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:49999-049-28 28 TABLET in 1 BOTTLE, PLASTIC None
5 NDC:49999-049-30 30 TABLET in 1 BOTTLE, PLASTIC None
6 NDC:49999-049-01 120 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078250 11/04/2011
Labeler — Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical DBA Quality Care Products LLC 831276758 repack (49999-049)

Revised: 07/2021 Lake Erie Medical DBA Quality Care Products LLC

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