FDA.reportPublic FDA data

LIPFENDRA

Product NDC
0006-5084
11-digit product format
000065084
Labeler code
0006
Product ID
0006-5084_24e1a57f-2be3-42ee-ad2d-981f813f2cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIPFENDRA
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA220848
Marketing category
NDA
Marketing start
2026-07-15
Substance
ENLICITIDE DECANOATE
Active strength
20 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
N220848-001LIPFENDRAENLICITIDE DECANOATEEQ 20MG BASETABLET / ORALRLD, RS2026-07-15

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220848-001114276162040-02-04U-4585Drug substance, Drug product2026-08-07

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220848-001NCE2031-07-15

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 22:38:342026-08N220848-001LIPFENDRAEQ 20MG BASETABLET / ORALRLD, RS2026-07-1584e616aacf4f…
2026-08-18 06:07:402026-07N220848-001LIPFENDRAEQ 20MG BASETABLET / ORALRLD, RS2026-07-15caaa826d4ba7…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N220848-001114276162040-02-04U-4585Drug substance, Drug product2026-08-0784e616aacf4f…
2026-08-18 06:07:402026-07N220848-001114276162040-02-04U-4585Drug substance, Drug product2026-08-07caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N220848-001NCE2031-07-1584e616aacf4f…
2026-08-18 06:07:402026-07N220848-001NCE2031-07-15caaa826d4ba7…

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
LIPFENDRA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENLICITIDE DECANOATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PSR59MCX5MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2747756Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
100ec543-fbd0-44fc-b740-db9cdff39145Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIPFENDRALIPFENDRAMerck Sharp & Dohme LLC100ec543-fbd0-44fc-b740-db9cdff391452026-07-15Adverse reactionsExact identifier
application applno (NDA): 220848
application number: NDA220848
ndc (product): 0006-5084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0006-5084-010000650840130 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) 2026-07-15NoNoCurrent
0006-5084-59000065084591 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) 1 bottle2026-07-15YesNoCurrent