NDC directory

Utebzi

Tebipenem Pivoxil · GlaxoSmithKline LLC · TABLET, FILM COATED

0173-0956NDA
Product NDC
0173-0956
Generic name
Tebipenem Pivoxil
Labeler name
GlaxoSmithKline LLC
Brand name
Utebzi
Finished
true
Listing expiration date
20271231
Marketing category
NDA
Dosage form
TABLET, FILM COATED
SPL ID
f0511453-5f6f-4e3a-b7d0-a5cfde985656
Product type
HUMAN PRESCRIPTION DRUG
Marketing start date
20261001
Product ID
0173-0956_f0511453-5f6f-4e3a-b7d0-a5cfde985656
Application number
NDA215960
Brand name base
Utebzi
Active ingredients
  1. Name
    TEBIPENEM PIVOXIL HYDROBROMIDE
    Strength
    300 mg/1
Packaging
  1. Package NDC
    0173-0956-76
    Description
    10 BLISTER PACK in 1 CARTON (0173-0956-76) / 8 TABLET, FILM COATED in 1 BLISTER PACK
    Marketing start date
    20261001
    Sample
    false
Route
ORAL
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.