emend

Generic: aprepitant

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name emend
Generic Name aprepitant
Labeler merck sharp & dohme llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

aprepitant 125 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-0462
Product ID 0006-0462_428f7828-6d1c-438b-a17d-b4af0700c740
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021549
Listing Expiration 2026-12-31
Marketing Start 2003-03-26

Pharmacologic Class

Established (EPC)
substance p/neurokinin-1 receptor antagonist [epc]
Mechanism of Action
neurokinin 1 antagonists [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 2c9 inducers [moa] cytochrome p450 3a4 inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00060462
Hyphenated Format 0006-0462

Supplemental Identifiers

RxCUI
403810 403811 404465 404466 644088 644278 754508 754509 1729308 1729311
UNII
1NF15YR6UY
NUI
N0000010262 N0000175786 N0000182141 N0000185507 N0000185506

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name emend (source: ndc)
Generic Name aprepitant (source: ndc)
Application Number NDA021549 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 80-mg capsules: White, opaque, hard gelatin capsule with "461" and "80 mg" printed radially in black ink on the body. They are supplied as follows: NDC 0006-0461-02 unit-of-use BiPack of 2 Unit-of-use TriPack containing one 125-mg capsule and two 80-mg capsules. 125 mg-capsules: Opaque, hard gelatin capsule with white body and pink cap with “462” and “125 mg” printed radially in black ink on the body. 80-mg capsules: White, opaque, hard gelatin capsule with “461” and “80 mg” printed radially in black ink on the body. NDC 0006-3862-03. 125 mg for oral suspension: Pink to light pink powder, in a single-use pouch, packaged as a kit with one 1 mL oral dosing dispenser, one 5 mL oral dosing dispenser, one cap and one mixing cup. It is supplied as follows: NDC 0006-3066-03 – unit of use carton. Storage and Handling Capsules Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. For Oral Suspension Store unopened pouch at 20-25°C (68-77°F); excursions permitted between 15-30°C (between 59-86°F). Store in the original container. Do not open pouch until ready for use. Once prepared, if suspension is not used immediately, store refrigerated [between 36°F-46°F (2°C-8°C)] for up to 72 hours prior to use. When ready to use, the mixture can be kept at room temperature [between 68°F-77°F (20°C-25°C)] for up to 3 hours.
  • PRINCIPAL DISPLAY PANEL - 80 mg Capsule Dose Pack NDC 0006-0461-02 Bi Pack 2 capsules EMEND ® (aprepitant) capsules 80 mg For Adults and Pediatric Patients 12 years of Age and Older You have already been given a capsule of EMEND (aprepitant) to prevent nausea and vomiting before your chemotherapy on Day 1. The two capsules in this package are to be taken on Days 2 and 3. Each capsule contains 80 mg of aprepitant. USUAL DOSAGE: See accompanying circular. Rx only Keep this and all drugs out of the reach of children. Dist. by: Merck Sharp & Dohme LLC Rahway, NJ 07065, USA Manuf. by: Alkermes Pharma Ireland Limited, Athlone, Ireland Aprepitant (active ingred.) Made in Switzerland. Formulated in Ireland. PRINCIPAL DISPLAY PANEL - 80 mg Capsule Dose Pack
  • PRINCIPAL DISPLAY PANEL - 125 mg Capsule Carton NDC 0006-0462-06 125 mg EMEND ® (APREPITANT) CAPSULES For Adults and Pediatric Patients 12 years of Age and Older Each capsule contains 125 mg aprepitant. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. USUAL DOSAGE: See accompanying circular. Rx only This is a bulk package and not intended for dispensing. Package not child resistant. 6 capsules PRINCIPAL DISPLAY PANEL - 125 mg Capsule Carton
  • PRINCIPAL DISPLAY PANEL - 3 Capsule Kit Carton NDC 0006-3862-03 Tri Pack 3 capsules EMEND ® (aprepitant) capsules 125 mg 80 mg For Adults and Pediatric Patients 12 years of Age and Older One 125-mg capsule contains 125 mg aprepitant. Two 80-mg capsules each containing 80 mg of aprepitant. USUAL DOSAGE: See accompanying circular. Rx only Keep this and all drugs out of the reach of children. Dist. by: Merck Sharp & Dohme LLC Rahway, NJ 07065, USA Manuf. by: Alkermes Pharma Ireland Limited, Athlone, Ireland Aprepitant (active ingred.) Made in Switzerland. Formulated in Ireland. PRINCIPAL DISPLAY PANEL - 3 Capsule Kit Carton
  • PRINCIPAL DISPLAY PANEL - 40 mg Capsule Carton NDC 0006-0464-10 40 mg EMEND ® (APREPITANT) CAPSULE Each capsule contains 40 mg aprepitant. Rx only Package not child resistant. Keep this and all drugs out of the reach of children. Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Manuf. by: Alkermes Pharma Ireland Limited, Athlone, Ireland Formulated in Ireland 1 Capsule PRINCIPAL DISPLAY PANEL - 40 mg Capsule Carton
  • PRINCIPAL DISPLAY PANEL - Kit Carton NDC 0006-3066-03 EMEND ® (aprepitant) for oral suspension 125 mg Single-Dose Kit Discard Unused Portion This product must be reconstituted and dose must be measured by a healthcare provider. See package insert and accompanying directions. For Oral Administration Only Rx only PRINCIPAL DISPLAY PANEL - Kit Carton
source: label

Packages (0)

No package records.

Ingredients (1)

aprepitant (125 mg/1)

Linked Drug Pages (1)

EMEND ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "428f7828-6d1c-438b-a17d-b4af0700c740", "openfda": {"nui": ["N0000010262", "N0000175786", "N0000182141", "N0000185507", "N0000185506"], "unii": ["1NF15YR6UY"], "rxcui": ["403810", "403811", "404465", "404466", "644088", "644278", "754508", "754509", "1729308", "1729311"], "spl_set_id": ["696f9e80-9cae-403b-de9e-078343ce4713"], "pharm_class_epc": ["Substance P/Neurokinin-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Neurokinin 1 Antagonists [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "EMEND", "product_id": "0006-0462_428f7828-6d1c-438b-a17d-b4af0700c740", "dosage_form": "CAPSULE", "pharm_class": ["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]"], "product_ndc": "0006-0462", "generic_name": "aprepitant", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EMEND", "active_ingredients": [{"name": "APREPITANT", "strength": "125 mg/1"}], "application_number": "NDA021549", "marketing_category": "NDA", "marketing_start_date": "20030326", "listing_expiration_date": "20261231"}