Norelgestromin

Drug ingredient

CAS 53016-31-2

This chemical is an active pharmaceutical ingredient used in FDA-regulated drugs.

US productionNot reported

Import value, 2024$154M

Top sourceItaly 60%

This chemical is not on EPA’s Toxic Substances Control Act inventory, the list behind EPA’s production survey.

Why supply is unknown

Production is reported production, not a complete census of factories. Import value and source-country shares describe a shared customs category, not a separate chemical measurement.

Where It Comes From

Customs basis: HS 293729 · basket

These shares come from HS customs code 293729, which covers 57 tracked chemicals in total. They estimate the category's origin mix, not this chemical specifically.

Source Countries

Country of origin for US imports, from Census customs data (2024).

IT 60%ItalyES 14%SpainCN 11%ChinaDE 6%GermanyAT 2%Austria

Netherlands
Australia
Malaysia
Portugal
United Kingdom
Japan
Malta
Canada
Israel
Singapore
New Zealand
Poland
Ukraine
Belgium
Sweden

11 FDA-registered drug labelers

A-S Medication Solutions

Amneal Pharmaceuticals LLC

Amneal Pharmaceuticals NY LLC

AvKARE

Bryant Ranch Prepack

Gador S.A.

Gedeon Richter Plc.

Mylan Pharmaceuticals Inc.

Sterling S.p.A.

Zydus Lifesciences Limited

Zydus Pharmaceuticals USA Inc.

Why It Matters

Sectors

Health

Downstream Uses

Appears in 4 drug and cosmetic product listings (FDA).

•Zafemy
•norelgestromin and ethinyl estradiol
•Norelgestromin and Ethinly Estradiol
•Xulane

FDA Shortage Status

Whether any manufacturer currently reports this drug as in shortage on the FDA Drug Shortages database. "Active Shortage" means at least one presentation has status "current."

No FDA shortage records

Chemical Identity

CAS53016-31-2

PubChem CID62930

DTXSIDDTXSID9046788

FormulaC21H29NO2

Mol. Weight327.5 g/mol

SMILESCCC12CCC3C(C1CCC2(C#C)O)CCC4=CC(=NO)CCC34

Data Sources

PubChem · compound 62930Retrieved 2026-04-07
FDA National Drug Code directoryRetrieved 2026-04-25
FDA National Drug Code directoryRetrieved 2026-04-07
US Census international tradeReporting year: 2024 · Retrieved 2026-10-04

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Brief citations

Norelgestromin (CAS 53016-31-2) https://chemicalindependence.com/chemical/53016-31-2/ PubChem: 62930. Retrieved 2026-04-07. https://pubchem.ncbi.nlm.nih.gov/compound/62930 FDA National Drug Code directory: CAS 53016-31-2. Retrieved 2026-04-25. https://open.fda.gov/data/ndc/ FDA National Drug Code directory: bulk match. Retrieved 2026-04-07. https://open.fda.gov/data/ndc/ US Census international trade: HS 293729 for CAS 53016-31-2. Reporting year: 2024. https://usatrade.census.gov/