Suppliers and packagers for seasonale

seasonale

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Branded Pharm	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0555-9123-66	3 POUCH in 1 CARTON (0555-9123-66) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2003-10-13

Suppliers and packagers for seasonale

Last updated: April 25, 2026

Who supplies Seasonale (levonorgestrel/ethinyl estradiol) and what’s the supply-chain footprint?

Seasonale is a combined oral contraceptive (COC) containing levonorgestrel and ethinyl estradiol. In the US, it is marketed as a brand under Duramed/Teva (now commonly reflected as Teva Women’s Health). The supply chain for Seasonale can be mapped into three layers: (1) NDA/brand holder, (2) commercial manufacturer/labeler, and (3) API and key excipient suppliers.

Brand holder and commercial labeler: who owns Seasonale in the market?

Seasonale’s US commercialization is tied to Teva Women’s Health / Duramed, with the product marketed as the brand of record for the levonorgestrel/ethinyl estradiol regimen.

Role	Entity	Evidence
Brand holder / labeler (US)	Teva Women’s Health / Duramed	Product listings and label authority for Seasonale in the US market (see citations)

What manufacturing footprint exists for Seasonale?

Seasonale tablets are produced under commercial manufacturing arrangements typical for oral contraceptives: a contract manufacturing organization (CMO) or internal plant makes finished dosage forms, while API and excipients are sourced from established suppliers of steroid APIs and pharmaceutical excipients.

Supply-chain footprint by functional layer

• Finished dosage form (tablets): manufactured by a commercial plant under Teva’s quality system for branded COCs.
• API: levonorgestrel and ethinyl estradiol steroid APIs sourced from specialized API manufacturers.
• Excipients: film-formers, fillers, binders, lubricants, and color agents sourced from major pharmaceutical excipient suppliers with OTC and prescription-grade offerings.

Who supplies the APIs for Seasonale?

For Seasonale (levonorgestrel/ethinyl estradiol), the relevant API class is steroid oral contraceptive intermediates and finished APIs. The market for these APIs is dominated by a small set of global API manufacturers that supply multiple COCs and generic equivalents.

API suppliers (levonorgestrel / ethinyl estradiol) commonly used across the class

• Steroid API specialists supplying levonorgestrel and ethinyl estradiol for COCs.
• US/EU regulatory-compliant producers whose APIs appear across COC supply chains, including branded and authorized generics.

What finished-dose suppliers are typically involved?

Finished-dose tablet production for COCs is generally concentrated among:

• CMOs with high-throughput solid oral dose lines
• Plant networks that support controlled release or uniformity-focused blend and compression programs
• Sites with experience in low-dose steroid formulations and coating systems

Seasonale is produced under the brand’s controlled manufacturing system, so the “supplier” answer in practice usually comes down to:

• the finished dose manufacturing site listed in regulatory/label documentation, and
• the CMO API + excipient chain feeding that site.

Regulatory and label sources used to identify suppliers

The operationally useful supplier list usually comes from:

• US prescribing information / label manufacturing information (finished dosage form sites and sometimes distributor/labeler)
• FDA databases that map product listing to labeler and manufacturer structures
• Drug master file (DMF) or API listing routes when publicly indexed

Seasonale supplier identification in the public domain is therefore primarily site-and-labeler centric rather than “who makes every ingredient” at supplier-of-record level.

Key takeaways

• Seasonale is a levonorgestrel/ethinyl estradiol COC branded in the US under Teva Women’s Health / Duramed.
• The supply chain breaks into finished dose manufacturing (tablets), API supply (levonorgestrel and ethinyl estradiol), and excipient supply.
• Publicly resolvable “supplier” information is most reliably extracted from US label/manufacturing listings and FDA product listing frameworks, while API and excipient suppliers often require deeper DMF-level tracing that is not consistently public for every brand.

FAQs

1. Is Seasonale made by Teva in-house?
   Seasonale is marketed under Teva’s label system; whether production is in-house versus CMO depends on the specific finished dosage manufacturing site listed for the marketed product.

2. What APIs does Seasonale use?
   Levonnorgestrel and ethinyl estradiol are the core APIs for Seasonale.

3. Can you list the exact levonorgestrel and ethinyl estradiol API suppliers for Seasonale from public sources?
   Public supplier-of-record detail for APIs is often not fully enumerated on the US label. Supplier mapping is typically done via regulatory product listings, DMF linkages, and controlled substance/API documentation, which is not uniformly public for every brand.

4. Who is the labeler for Seasonale in the US?
   Seasonale’s US commercialization is associated with Teva Women’s Health / Duramed.

5. Where do pharmaceutical “supplier” details come from for branded oral contraceptives?
   From prescribing information/label manufacturing statements, FDA product listing records, and controlled mapping to API/DMF holders when accessible.

References (APA)

[1] FDA. (n.d.). Drug products (FDA Orange Book) for Seasonale (levonorgestrel and ethinyl estradiol). U.S. Food and Drug Administration.
[2] DailyMed. (n.d.). Seasonale (levonorgestrel and ethinyl estradiol) tablets prescribing information. National Library of Medicine.
[3] FDA. (n.d.). Drugs@FDA: Seasonale (levonorgestrel and ethinyl estradiol). U.S. Food and Drug Administration.
[4] FDA. (n.d.). FDA Structured Product Labeling (SPL) for Seasonale. U.S. Food and Drug Administration.