repatha

Generic: evolocumab

Labeler: amgen usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name repatha
Generic Name evolocumab
Labeler amgen usa inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

evolocumab 140 mg/mL

Manufacturer
Amgen USA Inc.

Identifiers & Regulatory

Product NDC 72511-760
Product ID 72511-760_d9a0c476-16cf-46ae-8525-a89da9d76fc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125522
Listing Expiration 2027-12-31
Marketing Start 2018-10-09

Pharmacologic Class

Established (EPC)
pcsk9 inhibitor [epc]
Mechanism of Action
pcsk9 inhibitors [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72511760
Hyphenated Format 72511-760

Supplemental Identifiers

RxCUI
1665895 1665900 1665904 1665906 1801319 1801322
UPC
0372511770018
UNII
LKC0U3A8NJ
NUI
N0000191731 N0000191730 M0001357

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 repatha (source: ndc)
Generic Name evolocumab (source: ndc)
Application Number BLA125522 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 140 mg/mL
source: ndc
Packaging
  • 2 SYRINGE in 1 CARTON (72511-760-02) / 1 mL in 1 SYRINGE (72511-760-01)
  • 1 SYRINGE in 1 CARTON (72511-760-91) / 1 mL in 1 SYRINGE
source: ndc

Packages (2)

72511-760-02 2 SYRINGE in 1 CARTON (72511-760-02) / 1 mL in 1 SYRINGE (72511-760-01) 72511-760-91 1 SYRINGE in 1 CARTON (72511-760-91) / 1 mL in 1 SYRINGE

Ingredients (1)

evolocumab (140 mg/mL)

Linked Drug Pages (1)

REPATHA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "d9a0c476-16cf-46ae-8525-a89da9d76fc4", "openfda": {"nui": ["N0000191731", "N0000191730", "M0001357"], "upc": ["0372511770018"], "unii": ["LKC0U3A8NJ"], "rxcui": ["1665895", "1665900", "1665904", "1665906", "1801319", "1801322"], "spl_set_id": ["cd61e902-166d-4aa6-9f3c-a18c1008d07e"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["PCSK9 Inhibitor [EPC]"], "pharm_class_moa": ["PCSK9 Inhibitors [MoA]"], "manufacturer_name": ["Amgen USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE in 1 CARTON (72511-760-02)  / 1 mL in 1 SYRINGE (72511-760-01)", "package_ndc": "72511-760-02", "marketing_start_date": "20181009"}, {"sample": true, "description": "1 SYRINGE in 1 CARTON (72511-760-91)  / 1 mL in 1 SYRINGE", "package_ndc": "72511-760-91", "marketing_start_date": "20220601"}], "brand_name": "REPATHA", "product_id": "72511-760_d9a0c476-16cf-46ae-8525-a89da9d76fc4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "PCSK9 Inhibitor [EPC]", "PCSK9 Inhibitors [MoA]"], "product_ndc": "72511-760", "generic_name": "Evolocumab", "labeler_name": "Amgen USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "REPATHA", "active_ingredients": [{"name": "EVOLOCUMAB", "strength": "140 mg/mL"}], "application_number": "BLA125522", "marketing_category": "BLA", "marketing_start_date": "20181009", "listing_expiration_date": "20271231"}