Home NDC 0781-4063 Aprepitant
Product NDC 0781-4063
11-digit product format 007814063
Labeler code 0781
Product ID 0781-4063_a194823e-5961-4bc0-b18f-2f63d3cbb9c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name aprepitant
Dosage form KIT
Labeler Sandoz Inc
Application ANDA090999
Marketing category ANDA
Marketing start 2016-12-27
NDC exclude flag No
Listing certified through 2026-12-31
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 A090999-001 APREPITANT APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 A090999-002 APREPITANT APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 A090999-003 APREPITANT APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24
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 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090999-002 APREPITANT 80MG CAPSULE / ORAL AB 2012-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090999-003 APREPITANT 125MG CAPSULE / ORAL AB 2012-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090999-001 APREPITANT 40MG CAPSULE / ORAL AB 2012-09-24 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 2026-12-31 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-4063-36 Aprepitant 1 in 1 DOSE PACK KIT 1 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-4063 APREPITANT CAPSULE APREPITANT KIT [SANDOZ INC] 15 Current NDC, Legacy NDC, 1 package rows 20250224_f58b8944-93ee-4be1-a238-cc0061ddd93a.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 · 1 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 0781-4063-36 00781406336 1 KIT in 1 DOSE PACK (0781-4063-36) * 1 CAPSULE in 1 BLISTER PACK * 2 CAPSULE in 1 BLISTER PACK 1 kit 2016-12-27 0000-00-00 No No Current