aprepitant

Generic: aprepitant

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aprepitant
Generic Name aprepitant
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

aprepitant 80 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-584
Product ID 68462-584_41f97256-ac39-413d-8b2f-5fb7ad429143
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207777
Listing Expiration 2027-12-31
Marketing Start 2017-10-12

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 68462584
Hyphenated Format 68462-584

Supplemental Identifiers

RxCUI
403810 403811 644088 754508
UPC
0368462585764 0368462112335 0368462584767 0368462583401
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 aprepitant (source: ndc)
Generic Name aprepitant (source: ndc)
Application Number ANDA207777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 2 CAPSULE in 1 DOSE PACK (68462-584-58)
  • 1 BLISTER PACK in 1 CARTON (68462-584-76) / 6 CAPSULE in 1 BLISTER PACK (68462-584-40)
source: ndc

Packages (2)

68462-584-58 2 CAPSULE in 1 DOSE PACK (68462-584-58) 68462-584-76 1 BLISTER PACK in 1 CARTON (68462-584-76) / 6 CAPSULE in 1 BLISTER PACK (68462-584-40)

Ingredients (1)

aprepitant (80 mg/1)

Linked Drug Pages (1)

Aprepitant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41f97256-ac39-413d-8b2f-5fb7ad429143", "openfda": {"nui": ["N0000010262", "N0000175786", "N0000182141", "N0000185507", "N0000185506"], "upc": ["0368462585764", "0368462112335", "0368462584767", "0368462583401"], "unii": ["1NF15YR6UY"], "rxcui": ["403810", "403811", "644088", "754508"], "spl_set_id": ["d72e0e10-4557-41b0-b65d-d395468cad19"], "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": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CAPSULE in 1 DOSE PACK (68462-584-58)", "package_ndc": "68462-584-58", "marketing_start_date": "20171012"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68462-584-76)  / 6 CAPSULE in 1 BLISTER PACK (68462-584-40)", "package_ndc": "68462-584-76", "marketing_start_date": "20171012"}], "brand_name": "Aprepitant", "product_id": "68462-584_41f97256-ac39-413d-8b2f-5fb7ad429143", "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": "68462-584", "generic_name": "Aprepitant", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aprepitant", "active_ingredients": [{"name": "APREPITANT", "strength": "80 mg/1"}], "application_number": "ANDA207777", "marketing_category": "ANDA", "marketing_start_date": "20171012", "listing_expiration_date": "20271231"}