Home NDC 68462-583 Aprepitant
Product NDC 68462-583
11-digit product format 684620583
Labeler code 68462
Product ID 68462-583_41f97256-ac39-413d-8b2f-5fb7ad429143
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aprepitant
Dosage form CAPSULE
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA207777
Marketing category ANDA
Marketing start 2017-10-12
Substance APREPITANT
Active strength 40 mg/1
Pharmacologic classes Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]
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 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 A207777-001 APREPITANT APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 A207777-002 APREPITANT APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 A207777-003 APREPITANT APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207777-002 APREPITANT 80MG CAPSULE / ORAL AB 2017-10-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207777-003 APREPITANT 125MG CAPSULE / ORAL AB 2017-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207777-001 APREPITANT 40MG CAPSULE / ORAL AB 2017-10-12 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Aprepitant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APREPITANT 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1NF15YR6UY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403810 Internal RxNorm lookup 403811 Internal RxNorm lookup 644088 Internal RxNorm lookup 754508 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-583 APREPITANT CAPSULE APREPITANT KIT [GLENMARK PHARMACEUTICALS INC., USA] 12 Current NDC, Legacy NDC, 6 package rows 20240706_d72e0e10-4557-41b0-b65d-d395468cad19.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68462-583-11 68462058311 1 BLISTER PACK in 1 CARTON (68462-583-11) / 10 CAPSULE in 1 BLISTER PACK 1 blister pack 2017-10-12 0000-00-00 No No Current 68462-583-40 68462058340 1 BLISTER PACK in 1 CARTON (68462-583-40) / 1 CAPSULE in 1 BLISTER PACK 1 blister pack 2017-10-12 0000-00-00 No No Current 68462-583-85 68462058385 5 BLISTER PACK in 1 CARTON (68462-583-85) / 1 CAPSULE in 1 BLISTER PACK 5 blister pack 2017-10-12 0000-00-00 No No Current