FDA.reportPublic FDA data

Utebzi

Product NDC
0173-0956
11-digit product format
001730956
Labeler code
0173
Product ID
0173-0956_f0511453-5f6f-4e3a-b7d0-a5cfde985656
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tebipenem Pivoxil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA215960
Marketing category
NDA
Marketing start
2026-10-01
Substance
TEBIPENEM PIVOXIL HYDROBROMIDE
Active strength
300 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215960-001UTEBZITEBIPENEM PIVOXIL HYDROBROMIDEEQ 300MG BASETABLET / ORALRLD, RS2026-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215960-001122264032037-12-15U-4569Drug product2026-07-15
N215960-001108895872038-02-06U-4570Drug substance, Drug product2026-07-15

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215960-001NCE2031-06-17
N215960-001GAIN2036-06-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N215960-001UTEBZIEQ 300MG BASETABLET / ORALRLD, RS2026-06-1784e616aacf4f…
2026-08-18 06:07:402026-07N215960-001UTEBZIEQ 300MG BASETABLET / ORALRLD, RS2026-06-17caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215960-001UTEBZIEQ 300MG BASETABLET / ORALRLD, RS2026-06-17a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N215960-001122264032037-12-15U-4569Drug product2026-07-1584e616aacf4f…
2026-09-14 22:38:342026-08N215960-001108895872038-02-06U-4570Drug substance, Drug product2026-07-1584e616aacf4f…
2026-08-18 06:07:402026-07N215960-001122264032037-12-15U-4569Drug product2026-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07N215960-001108895872038-02-06U-4570Drug substance, Drug product2026-07-15caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N215960-001NCE2031-06-1784e616aacf4f…
2026-09-14 22:38:342026-08N215960-001GAIN2036-06-1784e616aacf4f…
2026-08-18 06:07:402026-07N215960-001NCE2031-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07N215960-001GAIN2036-06-17caaa826d4ba7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Utebzi
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEBIPENEM PIVOXIL HYDROBROMIDE300 mg/1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0173-0956-760017309567610 BLISTER PACK in 1 CARTON (0173-0956-76) / 8 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2026-10-01NoNoCurrent