estradiol valerate

Generic: estradiol valerate

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

Drug Facts

Product Profile

Brand Name estradiol valerate
Generic Name estradiol valerate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

estradiol valerate 40 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9291
Product ID 0143-9291_5fa9d3b5-6bfd-40e9-900e-21427f6c4d21
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203723
Listing Expiration 2026-12-31
Marketing Start 2020-04-21

Pharmacologic Class

Classes
estradiol congeners [cs] estrogen receptor agonists [moa] estrogen [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439291
Hyphenated Format 0143-9291

Supplemental Identifiers

RxCUI
310189 310190 310191
UNII
OKG364O896

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 estradiol valerate (source: ndc)
Generic Name estradiol valerate (source: ndc)
Application Number ANDA203723 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0143-9291-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

0143-9291-01 1 VIAL in 1 CARTON (0143-9291-01) / 5 mL in 1 VIAL

Ingredients (1)

estradiol valerate (40 mg/mL)

Linked Drug Pages (1)

Estradiol Valerate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "5fa9d3b5-6bfd-40e9-900e-21427f6c4d21", "openfda": {"unii": ["OKG364O896"], "rxcui": ["310189", "310190", "310191"], "spl_set_id": ["66f40ab0-4432-4e85-b709-a0bc076868c6"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0143-9291-01)  / 5 mL in 1 VIAL", "package_ndc": "0143-9291-01", "marketing_start_date": "20200421"}], "brand_name": "Estradiol Valerate", "product_id": "0143-9291_5fa9d3b5-6bfd-40e9-900e-21427f6c4d21", "dosage_form": "INJECTION", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "0143-9291", "generic_name": "Estradiol Valerate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol Valerate", "active_ingredients": [{"name": "ESTRADIOL VALERATE", "strength": "40 mg/mL"}], "application_number": "ANDA203723", "marketing_category": "ANDA", "marketing_start_date": "20200421", "listing_expiration_date": "20261231"}