eptifibatide

Generic: eptifibatide

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eptifibatide
Generic Name eptifibatide
Labeler slate run pharmaceuticals, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

eptifibatide .75 mg/mL

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-027
Product ID 70436-027_4a613f2d-85b3-d45c-e063-6294a90adb93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209864
Listing Expiration 2027-12-31
Marketing Start 2019-07-22

Pharmacologic Class

Established (EPC)
platelet aggregation inhibitor [epc]
Physiologic Effect
decreased platelet aggregation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70436027
Hyphenated Format 70436-027

Supplemental Identifiers

RxCUI
200349 1736470
UPC
0370436027804
UNII
NA8320J834
NUI
N0000008832 N0000175578

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 eptifibatide (source: ndc)
Generic Name eptifibatide (source: ndc)
Application Number ANDA209864 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .75 mg/mL
source: ndc
Packaging
  • 100 mL in 1 VIAL (70436-027-80)
source: ndc

Packages (1)

70436-027-80 100 mL in 1 VIAL (70436-027-80)

Ingredients (1)

eptifibatide (.75 mg/mL)

Linked Drug Pages (1)

Eptifibatide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4a613f2d-85b3-d45c-e063-6294a90adb93", "openfda": {"nui": ["N0000008832", "N0000175578"], "upc": ["0370436027804"], "unii": ["NA8320J834"], "rxcui": ["200349", "1736470"], "spl_set_id": ["da421d88-6c00-428a-82a6-b3b4f7a68b85"], "pharm_class_pe": ["Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Platelet Aggregation Inhibitor [EPC]"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 VIAL (70436-027-80)", "package_ndc": "70436-027-80", "marketing_start_date": "20190722"}], "brand_name": "Eptifibatide", "product_id": "70436-027_4a613f2d-85b3-d45c-e063-6294a90adb93", "dosage_form": "INJECTION", "pharm_class": ["Decreased Platelet Aggregation [PE]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "70436-027", "generic_name": "eptifibatide", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eptifibatide", "active_ingredients": [{"name": "EPTIFIBATIDE", "strength": ".75 mg/mL"}], "application_number": "ANDA209864", "marketing_category": "ANDA", "marketing_start_date": "20190722", "listing_expiration_date": "20271231"}