estradiol valerate

Generic: estradiol valerate

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol valerate
Generic Name estradiol valerate
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

estradiol valerate 20 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-0420
Product ID 0517-0420_abfdb011-4fe4-4c0f-b2df-77398b47738f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090920
Listing Expiration 2026-12-31
Marketing Start 2020-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05170420
Hyphenated Format 0517-0420

Supplemental Identifiers

RxCUI
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 ANDA090920 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0517-0420-01 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01) / 5 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

estradiol valerate (20 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": "abfdb011-4fe4-4c0f-b2df-77398b47738f", "openfda": {"unii": ["OKG364O896"], "rxcui": ["310190", "310191"], "spl_set_id": ["2984bce2-89bf-4768-a1ca-ccf03b1197be"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0517-0420-01", "marketing_start_date": "20200301"}], "brand_name": "ESTRADIOL VALERATE", "product_id": "0517-0420_abfdb011-4fe4-4c0f-b2df-77398b47738f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "0517-0420", "generic_name": "ESTRADIOL VALERATE", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESTRADIOL VALERATE", "active_ingredients": [{"name": "ESTRADIOL VALERATE", "strength": "20 mg/mL"}], "application_number": "ANDA090920", "marketing_category": "ANDA", "marketing_start_date": "20200301", "listing_expiration_date": "20261231"}