Home NDC 13668-748 APREPITANT
Product NDC 13668-748
11-digit product format 136680748
Labeler code 13668
Product ID 13668-748_f731e4a2-1a44-4b55-9279-c49f93528bfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name APREPITANT
Dosage form CAPSULE
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA211835
Marketing category ANDA
Marketing start 2026-10-20
Substance APREPITANT
Active strength 125 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 45 .
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 A211835-001 APREPITANT APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 A211835-002 APREPITANT APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 A211835-003 APREPITANT APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21
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 3 · 120 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 2026-11-14 07:37:17 2026-10 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211835-002 APREPITANT 80MG CAPSULE / ORAL AB 2020-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211835-003 APREPITANT 125MG CAPSULE / ORAL AB 2020-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211835-001 APREPITANT 40MG CAPSULE / ORAL AB 2020-10-21 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 3 · 120 observed states.
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 APREPITANT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APREPITANT 125 mg/1
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join APREPITANT APREPITANT Golden State Medical Supply, Inc. 377c3ecb-fdec-dde4-e063-6294a90a29bd 2026-03-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211835 application number: ANDA211835
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 13668-748-86 13668074886 6 BLISTER PACK in 1 CARTON (13668-748-86) / 1 CAPSULE in 1 BLISTER PACK (13668-748-80) 6 blister pack 2026-10-20 No No Current