Last updated: May 17, 2026
DASETTA 1/35 Suppliers: Who Manufactures and Supplies the Marketed Product (US/Global)
DASETTA 1/35 is a fixed-dose combined oral contraceptive containing ethinyl estradiol 35 mcg and levonorgestrel 1 mg (listed as a generic equivalency for “DASETTA 1/35”). Supplier coverage depends on country-level marketing authorizations and whether the unit is sold as the branded product or under generic labeling. Without jurisdiction and package configuration (tablet count, strength presentation, and market), a complete, accurate supplier roster cannot be produced.
Which companies supply DASETTA 1/35 in the US market?
A DASETTA 1/35 supplier map for the US requires the drug’s FDA label listing and manufacturer/distributor fields (NDC-to-lot trace), typically tied to Orange Book records or the electronic drug label. Those records are jurisdiction-specific and cannot be derived from the product name alone.
What does “DASETTA 1/35” correspond to on the label?
In most markets, the trade name maps to the same API combination:
- Levonorgestrel 1 mg
- Ethinyl estradiol 35 mcg
- Dosage form: oral tablet
How many suppliers exist for DASETTA 1/35 tablets by NDC and package?
Supplier counts vary because multiple presentations (different tablet counts per bottle and different marketing labels) can have different manufacturers and labelers even when the APIs are the same. A count requires NDC-level data or local trade catalog records.
What is the Orange Book status of DASETTA 1/35?
Orange Book status requires an exact US product identifier (typically an FDA application number and NDA/ANDA listing). The supplied input does not include the US listing identity, so the Orange Book posture cannot be stated.
Is DASETTA 1/35 branded or generic in the US?
This is label- and listing-dependent. Some countries sell “DASETTA 1/35” as a brand; others list it as a generic under the same strengths. A definitive answer requires the specific marketed product listing.
Which API manufacturers supply levonorgestrel 1 mg + ethinyl estradiol 35 mcg for DASETTA 1/35?
API supply is commonly split between:
- API makers (levonorgestrel and ethinyl estradiol),
- formulators (tableting/blending),
- finish-and-pack sites,
- labelers/distributors.
A supplier list for the finished dosage form cannot be generated without market authorization and product code mapping.
What generic or branded versions compete with DASETTA 1/35?
Competitors depend on local tendering and national formulary systems. The same active ingredients and strength are sold under multiple brand and generic names, and “supplier” is often interchangeable with “labeler” at the trade level.
What risks exist when switching suppliers for DASETTA 1/35?
Switching risks for combined oral contraceptives typically involve:
- bioavailability-critical excipient differences,
- batch-to-batch quality attributes,
- packaging changes affecting stability and traceability,
- regulatory listing changes.
A supplier-specific risk profile requires supplier identity by site and regulatory dossier.
Supplier due diligence checklist for DASETTA 1/35 (what to verify)
If identifying suppliers for regulatory, licensing, or procurement:
- manufacturing site GMP status for oral tablets,
- regulatory submission alignment (country-specific),
- traceability (lot release data, stability protocol),
- labeling authorization match to local NDC/marketing authorization,
- change control history affecting excipients and dissolution specs.
Key Takeaways
- “DASETTA 1/35” maps to a fixed-dose combination (levonorgestrel 1 mg / ethinyl estradiol 35 mcg), but supplier identification is market-specific.
- A complete and accurate supplier roster requires jurisdiction-level product identifiers tied to manufacturer/labeler records.
FAQs
- Who is the manufacturer of levonorgestrel 1 mg / ethinyl estradiol 35 mcg tablets sold as DASETTA 1/35?
- Are DASETTA 1/35 suppliers the same across countries with identical strengths?
- How do I identify the true labeler and manufacturer for DASETTA 1/35 by package?
- What documentation is required to qualify a new supplier of DASETTA 1/35?
- Do DASETTA 1/35 generic entrants share the same API suppliers as the original brand?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
