Home Applications 021549 Application 021549
Type NDA
Sponsor MERCK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMEND APREPITANT CAPSULE;ORAL 80MG Yes No 002 EMEND APREPITANT CAPSULE;ORAL 125MG Yes Yes 003 EMEND APREPITANT CAPSULE;ORAL 40MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021549-001 EMEND APREPITANT 80MG CAPSULE / ORAL AB RLD 2003-03-26 N021549-002 EMEND APREPITANT 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 N021549-003 EMEND APREPITANT 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021549-001 8258132 2027-09-26 U-1743 Drug product 2012-09-27 N021549-001 8258132 2027-09-26 U-901 Drug product 2012-09-27 N021549-002 8258132 2027-09-26 U-1743 Drug product N021549-002 8258132 2027-09-26 U-901 Drug product N021549-003 8258132 2027-09-26 U-1743 Drug product N021549-003 8258132 2027-09-26 U-901 Drug product
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.
Product history page 1 of 4 · 126 observed 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 2026-08-18 06:07:40 2026-07 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021549-002 EMEND 125MG CAPSULE / ORAL AB RLD, RS 2003-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021549-003 EMEND 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021549-001 EMEND 80MG CAPSULE / ORAL AB RLD 2003-03-26 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 252 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N021549-001 8258132 2027-09-26 U-1743 Drug product 2012-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021549-001 8258132 2027-09-26 U-901 Drug product 2012-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021549-002 8258132 2027-09-26 U-901 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021549-002 8258132 2027-09-26 U-1743 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021549-003 8258132 2027-09-26 U-901 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021549-003 8258132 2027-09-26 U-1743 Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021549-001 8258132 2027-09-26 U-1743 Drug product 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021549-001 8258132 2027-09-26 U-901 Drug product 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021549-002 8258132 2027-09-26 U-901 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021549-002 8258132 2027-09-26 U-1743 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021549-003 8258132 2027-09-26 U-901 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021549-003 8258132 2027-09-26 U-1743 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021549-001 8258132 2027-09-26 U-1743 Drug product 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021549-001 8258132 2027-09-26 U-901 Drug product 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021549-002 8258132 2027-09-26 U-901 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021549-002 8258132 2027-09-26 U-1743 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021549-003 8258132 2027-09-26 U-901 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021549-003 8258132 2027-09-26 U-1743 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021549-001 8258132 2027-09-26 U-1743 Drug product 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021549-001 8258132 2027-09-26 U-901 Drug product 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021549-002 8258132 2027-09-26 U-901 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021549-002 8258132 2027-09-26 U-1743 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021549-003 8258132 2027-09-26 U-901 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021549-003 8258132 2027-09-26 U-1743 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021549-001 8258132 2027-09-26 U-1743 Drug product 2012-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021549-001 8258132 2027-09-26 U-901 Drug product 2012-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021549-002 8258132 2027-09-26 U-901 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021549-002 8258132 2027-09-26 U-1743 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021549-003 8258132 2027-09-26 U-901 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021549-003 8258132 2027-09-26 U-1743 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021549-001 8258132 2027-09-26 U-1743 Drug product 2012-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021549-001 8258132 2027-09-26 U-901 Drug product 2012-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021549-002 8258132 2027-09-26 U-901 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021549-002 8258132 2027-09-26 U-1743 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021549-003 8258132 2027-09-26 U-901 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021549-003 8258132 2027-09-26 U-1743 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021549-001 8258132 2027-09-26 U-1743 Drug product 2012-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021549-001 8258132 2027-09-26 U-901 Drug product 2012-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021549-002 8258132 2027-09-26 U-901 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021549-002 8258132 2027-09-26 U-1743 Drug product 03ed91905a0d…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 33 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-0461 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0461 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0461 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0461 EMEND aprepitant Merck Sharp & Dohme LLC NDA Current 0006-0461 EMEND aprepitant Merck Sharp & Dohme LLC NDA Current 0006-0461 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0461 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0461 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0462 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0462 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0462 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0462 EMEND aprepitant Merck Sharp & Dohme LLC NDA Current 0006-0462 EMEND aprepitant Merck Sharp & Dohme LLC NDA Current 0006-0462 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0462 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0462 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0464 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0464 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0464 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0464 EMEND aprepitant Merck Sharp & Dohme LLC NDA Current 0006-0464 EMEND aprepitant Merck Sharp & Dohme LLC NDA Current 0006-0464 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0464 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-0464 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3862 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3862 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3862 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3862 EMEND aprepitant Merck Sharp & Dohme LLC NDA Current 0006-3862 EMEND aprepitant Merck Sharp & Dohme LLC NDA Current 0006-3862 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3862 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 0006-3862 EMEND aprepitant Merck Sharp & Dohme Corp. NDA Current 42254-160 EMEND aprepitant Rebel Distributors Corp NDA Current