Aprepitant

Product NDC
68001-667
11-digit product format
680010667
Labeler code
68001
Product ID
68001-667_4e00638d-1cbc-f20f-e063-6294a90ac14c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aprepitant
Dosage form
CAPSULE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA207777
Marketing category
ANDA
Marketing start
2026-01-29
Substance
APREPITANT
Active strength
80 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-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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207777-002APREPITANT80MGCAPSULE / ORALAB2017-10-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207777-003APREPITANT125MGCAPSULE / ORALAB2017-10-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207777-001APREPITANT40MGCAPSULE / ORALAB2017-10-121e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207777-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207777-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207777-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207777-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207777-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207777-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Aprepitant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APREPITANT80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1NF15YR6UYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403810Internal RxNorm lookup
403811Internal RxNorm lookup
644088Internal RxNorm lookup
754508Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a78aaa00-a46b-4f9e-a415-2fca9e9a4fb4Available on FDA.report

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
68001-667-01Aprepitant2 in 1 DOSE PACKCAPSULE22
68001-667-19Aprepitant1 in 1 CARTONCAPSULE12
68001-667-44Aprepitant6 in 1 BLISTER PACKCAPSULE62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-667-01EA - Each68001-6673cb00d9f-d52e-4d55-8975-818a09c80f1c12025-12-16
68001-667-19EA - Each68001-667594d07e5-1a4c-4238-932c-434075cb87fd12025-12-16

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AprepitantAPREPITANTBluePoint Laboratoriesa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207777
application number: ANDA207777
ndc (product): 68001-667
AprepitantAPREPITANTGlenmark Pharmaceuticals Inc., USAd72e0e10-4557-41b0-b65d-d395468cad192026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207777
application number: ANDA207777

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
754508{1 (aprepitant 125 MG Oral Capsule) / 2 (aprepitant 80 MG Oral Capsule) } PackGPCKa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
754508aprepitant 125 MG (1), 80 MG (2) Oral Capsule 3 Count PackPSNa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
403811aprepitant 125 MG Oral CapsulePSNa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
644088aprepitant 40 MG Oral CapsulePSNa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
403810aprepitant 80 MG Oral CapsulePSNa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
403811aprepitant 125 MG Oral CapsuleSCDa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
644088aprepitant 40 MG Oral CapsuleSCDa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
403810aprepitant 80 MG Oral CapsuleSCDa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-667-01680010667012 CAPSULE in 1 DOSE PACK (68001-667-01) 2 capsule2026-02-02NoNoCurrent
68001-667-19680010667191 BLISTER PACK in 1 CARTON (68001-667-19) / 6 CAPSULE in 1 BLISTER PACK (68001-667-44) 1 blister pack2026-01-29NoNoCurrent
68001-667-44680010667446 in 1 BLISTER PACKHistorical