Aprepitant

Product NDC
68462-112
11-digit product format
684620112
Labeler code
68462
Product ID
68462-112_39fda225-0fa7-41d3-85b1-6ea966847331
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aprepitant
Dosage form
KIT
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA207777
Marketing category
ANDA
Marketing start
2017-10-12
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 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207777-001APREPITANTAPREPITANT40MGCAPSULE / ORALAB2017-10-12
A207777-002APREPITANTAPREPITANT80MGCAPSULE / ORALAB2017-10-12
A207777-003APREPITANTAPREPITANT125MGCAPSULE / ORALAB2017-10-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207777-001AB
A207777-002AB
A207777-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-12c2088c7a36db…
2026-10-15 13:18:302026-09A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-12c2088c7a36db…
2026-10-15 13:18:302026-09A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-12c2088c7a36db…
2026-09-14 22:38:342026-08A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-1284e616aacf4f…
2026-09-14 22:38:342026-08A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-1284e616aacf4f…
2026-09-14 22:38:342026-08A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-1284e616aacf4f…
2026-08-18 06:07:402026-07A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-1279d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A207777-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A207777-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A207777-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A207777-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207777-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207777-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A207777-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207777-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207777-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207777-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207777-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207777-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207777-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207777-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207777-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207777-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207777-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207777-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207777-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207777-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207777-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207777-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207777-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207777-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207777-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207777-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207777-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207777-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207777-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207777-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207777-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207777-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207777-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207777-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207777-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207777-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207777-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207777-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207777-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207777-001AB179d66fd596c7…

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2abc3e32-ae1f-4dec-be1c-0c39ac95b38eProduct name720240514
5d352eda-d4de-4572-9a3f-32d6fd204f9aProduct name120230911
3a5d67cc-4a03-45a3-8d74-5aeb67631be4Product name120230831
85fc66a9-58b2-e194-7cdb-89ff44dcf3e6Product name420210518
9f9a82fd-fcee-442f-9233-7f2d2f9f4568Product name120180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-112-33Aprepitant1 in 1 DOSE PACKKIT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-112-33EA - Each68462-11218a3b64e-0f23-46bf-b923-85f3ddc298e112017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-112APREPITANT CAPSULE APREPITANT KIT [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 1 package rows20240706_d72e0e10-4557-41b0-b65d-d395468cad19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
754508{1 (aprepitant 125 MG Oral Capsule) / 2 (aprepitant 80 MG Oral Capsule) } PackGPCKd72e0e10-4557-41b0-b65d-d395468cad1913
754508aprepitant 125 MG (1), 80 MG (2) Oral Capsule 3 Count PackPSNd72e0e10-4557-41b0-b65d-d395468cad1913
403811aprepitant 125 MG Oral CapsulePSNd72e0e10-4557-41b0-b65d-d395468cad1913
644088aprepitant 40 MG Oral CapsulePSNd72e0e10-4557-41b0-b65d-d395468cad1913
403810aprepitant 80 MG Oral CapsulePSNd72e0e10-4557-41b0-b65d-d395468cad1913
403811aprepitant 125 MG Oral CapsuleSCDd72e0e10-4557-41b0-b65d-d395468cad1913
644088aprepitant 40 MG Oral CapsuleSCDd72e0e10-4557-41b0-b65d-d395468cad1913
403810aprepitant 80 MG Oral CapsuleSCDd72e0e10-4557-41b0-b65d-d395468cad1913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-112-33684620112331 KIT in 1 DOSE PACK (68462-112-33) * 2 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK1 kit2017-10-120000-00-00NoNoCurrent