wainua

Generic: eplontersen

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name wainua
Generic Name eplontersen
Labeler astrazeneca pharmaceuticals lp
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

eplontersen 45 mg/.8mL

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-9400
Product ID 0310-9400_97ea43e5-c637-4d33-9483-514e8d06af80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217388
Listing Expiration 2027-12-31
Marketing Start 2023-12-21

Pharmacologic Class

Established (EPC)
transthyretin-directed rna interaction [epc] antisense oligonucleotide [epc]
Chemical Structure
oligonucleotides, antisense [cs]
Physiologic Effect
decreased rna integrity [pe] increased protein breakdown [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03109400
Hyphenated Format 0310-9400

Supplemental Identifiers

RxCUI
2671944 2671950
UNII
0GRZ0F5XJ6
NUI
N0000193849 N0000191626 M0025055 N0000008852 N0000009531

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 wainua (source: ndc)
Generic Name eplontersen (source: ndc)
Application Number NDA217388 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/.8mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (0310-9400-01) / .8 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

0310-9400-01 1 SYRINGE, GLASS in 1 CARTON (0310-9400-01) / .8 mL in 1 SYRINGE, GLASS

Ingredients (1)

eplontersen (45 mg/.8mL)

Linked Drug Pages (1)

WAINUA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "97ea43e5-c637-4d33-9483-514e8d06af80", "openfda": {"nui": ["N0000193849", "N0000191626", "M0025055", "N0000008852", "N0000009531"], "unii": ["0GRZ0F5XJ6"], "rxcui": ["2671944", "2671950"], "spl_set_id": ["d7dcb847-71dd-4fff-82d0-d43a465fc096"], "pharm_class_cs": ["Oligonucleotides, Antisense [CS]"], "pharm_class_pe": ["Decreased RNA Integrity [PE]", "Increased Protein Breakdown [PE]"], "pharm_class_epc": ["Transthyretin-directed RNA Interaction [EPC]", "Antisense Oligonucleotide [EPC]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (0310-9400-01)  / .8 mL in 1 SYRINGE, GLASS", "package_ndc": "0310-9400-01", "marketing_start_date": "20231221"}], "brand_name": "WAINUA", "product_id": "0310-9400_97ea43e5-c637-4d33-9483-514e8d06af80", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antisense Oligonucleotide [EPC]", "Decreased RNA Integrity [PE]", "Increased Protein Breakdown [PE]", "Oligonucleotides", "Antisense [CS]", "Transthyretin-directed RNA Interaction [EPC]"], "product_ndc": "0310-9400", "generic_name": "EPLONTERSEN", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "WAINUA", "active_ingredients": [{"name": "EPLONTERSEN", "strength": "45 mg/.8mL"}], "application_number": "NDA217388", "marketing_category": "NDA", "marketing_start_date": "20231221", "listing_expiration_date": "20271231"}