Home NDC 0006-5084-01 LIPFENDRA
Product NDC 0006-5084
Requested package NDC 0006-5084-01
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220848-001 LIPFENDRA ENLICITIDE DECANOATE EQ 20MG BASE TABLET / ORAL RLD, RS 2026-07-15
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N220848-001 11427616 2040-02-04 U-4585 Drug substance, Drug product 2026-08-07
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N220848-001 NCE 2031-07-15
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N220848-001 LIPFENDRA EQ 20MG BASE TABLET / ORAL RLD, RS 2026-07-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220848-001 LIPFENDRA EQ 20MG BASE TABLET / ORAL RLD, RS 2026-07-15 caaa826d4ba7…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N220848-001 11427616 2040-02-04 U-4585 Drug substance, Drug product 2026-08-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220848-001 11427616 2040-02-04 U-4585 Drug substance, Drug product 2026-08-07 caaa826d4ba7…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 N220848-001 NCE 2031-07-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220848-001 NCE 2031-07-15 caaa826d4ba7…
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 Ingredient Strength ENLICITIDE DECANOATE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PSR59MCX5M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2747756 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0006-5084-01 00006508401 30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) 2026-07-15 No No Current