Label: LIDOCAINE 5%- lidocaine patch
- NDC Code(s): 80175-0118-3
- Packager: Central Packaging
- This is a repackaged label.
- Source NDC Code(s): 42858-118
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 11, 2021
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DOSAGE FORMS & STRENGTHS
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDOCAINE 5%
lidocaine patchProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80175-0118(NDC:42858-118) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 700 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80175-0118-3 30 in 1 PACKAGE 05/14/2020 1 1 in 1 PATCH 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209190 05/14/2020 Labeler - Central Packaging (117617671) Establishment Name Address ID/FEI Business Operations Central Packaging, LLC 117617671 repack(80175-0118)
