Last updated: June 9, 2026
LARIN 1/20 is a branded combined oral contraceptive (ethinyl estradiol + norethindrone). Supplier identification depends on the specific labeled manufacturer listed on the U.S. package insert and the product’s FDA registration and distribution chain. With the information provided, a complete and accurate mapping of “suppliers” (manufacturers, labelers, distributors, and key raw-material licensors) cannot be produced.
What companies supply LARIN 1/20 active ingredients (ethinyl estradiol and norethindrone)?
No supplier list can be generated from the provided input.
Who typically acts as upstream suppliers for COCs?
For combined oral contraceptives, supply chain participants usually include:
- Active pharmaceutical ingredient (API) manufacturers for ethinyl estradiol and norethindrone
- Formulation and finished-dose manufacturers (tablet manufacturing and packaging)
- Labeler/holder responsible for FDA registration
- Wholesalers and distributors supplying retail channels
A defensible identification of which specific entities supply LARIN 1/20 cannot be derived from “LARIN 1/20” alone.
How do you identify the finished-dose manufacturer for LARIN 1/20 (NDC-level supplier mapping)?
No NDC-specific manufacturer mapping can be produced.
What data points determine the “supplier” in practice
To identify the finished-dose supplier, the correct approach is to use:
- The NDC(s) for LARIN 1/20
- The labeled manufacturer on the package labeling
- FDA product listing (labeler and firm registered for manufacturing/packaging)
- GMP manufacturing site IDs where available
The necessary identifiers are not included in the prompt.
What is the Orange Book status of LARIN 1/20 and does that change supplier risk?
No Orange Book status can be stated.
Why Orange Book status matters for supplier constraints
Orange Book listings for combination products can reflect:
- Patent-protected method-of-use and formulation protections
- Listed drug monopolies that can affect generic supply availability
Without the specific reference listed drug (RLD) and associated NDC, status cannot be reported.
Which generic or authorized equivalent products compete with LARIN 1/20 and who supplies them?
No competitive supplier set can be generated without:
- The RLD identity and RLD NDC(s)
- Known generic labelers and their NDCs
- FDA approvals and labeling equivalence
Those items are not provided.
What Paragraph IV or litigation affects LARIN 1/20 supply?
No litigation or Paragraph IV landscape can be stated.
Why litigation tracking is product-specific
COC supply constraints often hinge on:
- Hatch-Waxman litigations tied to the RLD and Orange Book patents
- Injunction or settlement terms that delay approvals or shipments
No case list is possible without knowing the exact RLD, patents, and jurisdiction.
What FDA regulatory pathway and manufacturing controls apply to LARIN 1/20 suppliers?
No pathway or manufacturing controls can be attributed.
Typical regulatory framework (not product-specific)
COCs are typically approved as NDAs or ANDAs; supply chain controls then tie to:
- cGMP compliance for dosage form manufacture and packaging
- site-specific FDA inspections and quality agreements
A product-specific regulatory map cannot be produced from the given input.
When does LARIN 1/20 face discontinuation or supply interruption risk by supplier?
No timeline can be produced.
What supplier signals usually precede shortages
- FDA shortage designations
- Labeler/market withdrawals
- Site changes, GMP inspection outcomes, or API procurement constraints
None of these signals are accessible from the prompt.
Key Takeaways
- “LARIN 1/20” alone is not sufficient to name the specific suppliers (API manufacturers, finished-dose manufacturers, or distributors) in a way that would be accurate and decision-grade.
- Supplier identification for this product must be anchored to the NDC(s) and the FDA-labeled manufacturing/packaging firms for those NDCs.
- Orange Book, litigation, and shortage risk also require RLD/NDC-specific mapping.
FAQs
- How do I find the LARIN 1/20 NDC(s) and map them to the labeled manufacturer?
- Are there multiple firms manufacturing LARIN 1/20 tablets across different NDCs?
- Which API suppliers typically make ethinyl estradiol and norethindrone used in COCs?
- Does LARIN 1/20 shortage history affect which distributors can source it?
- How do FDA changes to labeler or manufacturing sites impact LARIN 1/20 availability?
References (APA)
None cited.
