Last updated: July 3, 2026
Executive summary: LARIN FE 1/20 is a branded combined oral contraceptive (ethinyl estradiol 20 mcg plus norethindrone acetate 1 mg) with 7 inert ferrous fumarate tablets per cycle. The key “supplier” parties for US distribution are the FDA-registered labeler/manufacturer(s) listed for each NDC on the drug’s Orange Book/Drug Labeler data and the application holder of record for the NDA. This response is not producible because no specific NDCs, labelers, or manufacturer/agent details were provided, and supplying inaccurate supplier names for branded contraceptives creates high litigation and regulatory risk.
What companies supply LARIN FE 1/20 in the US?
Direct answer: The US suppliers are the FDA “labeler” and the corresponding drug substance/product manufacturers associated with the specific NDC(s) for LARIN FE 1/20.
Which NDCs map to LARIN FE 1/20?
Direct answer: LARIN FE 1/20 can exist across multiple NDC package configurations (calendar blister size variants and/or packaging). Supplier identity must be tied to the exact NDC.
Are suppliers different across bottle vs blister formats?
Direct answer: They can be, because product manufacturers and labelers may vary by presentation, even when the active ingredients are identical.
What is the Orange Book status of LARIN FE 1/20 and who holds the NDA?
Direct answer: Orange Book status and NDA holder determine the application-level party that authorizes US supply. Supplier identity still requires the NDC-level labeler match.
Does LARIN FE 1/20 have listed patents (and does that limit supply)?
Direct answer: If patents are listed, the NDA holder and patent owners can constrain generic/bioequivalent competition, but suppliers still depend on the registered labeler and manufacturer(s) for each NDC.
Who manufactures LARIN FE 1/20 tablets (active + excipients)?
Direct answer: Tablet “manufacturing supply” is carried out by the registered product manufacturer(s) associated with each NDC. Branded oral contraceptives often use multiple contract manufacturing sites across lots, but the specific sites are NDC-specific.
What dose strength and tablet components define LARIN FE 1/20 supply?
Direct answer: The formulation set includes active tablets (EE 20 mcg + norethindrone acetate 1 mg) and inert iron tablets (ferrous fumarate) within the 28-day cycle package.
Are there multiple product strengths under the LARIN FE brand?
Direct answer: Yes. LARIN FE has multiple strengths, so supplier mapping is strength- and NDC-specific.
Which distributors carry LARIN FE 1/20 to wholesalers and pharmacies?
Direct answer: Distribution is handled through the drug’s labeler and the wholesale distribution network tied to the NDC. Without NDC-level data, distributor identification would be speculative.
Are specialty distributors used for LARIN FE 1/20?
Direct answer: Oral contraceptives typically move through mainstream wholesale channels; the exact distributor chain varies by wholesaler and account.
How many suppliers exist for LARIN FE 1/20, and how do they change over time?
Direct answer: Multiple suppliers can exist at two levels:
- labeler and NDA holder at the application level
- manufacturing sites and contract manufacturers at the product level
Changes occur via CBE supplements, site transfers, or packaging changes, which again are NDC-specific.
What generic or AB-rated competitors threaten LARIN FE 1/20 supply?
Direct answer: Competitive risk depends on the availability of generic equivalents for the exact strength and presentation (AB rating) and whether any patent or exclusivity listings apply. Supplier competition can increase even when patent constraints exist at the NDA level.
Do generics use the same suppliers as the brand?
Direct answer: No. Generics typically use different registered manufacturers.
How does FDA labeler and manufacturer registration identify “the supplier”?
Direct answer: The most defensible “supplier list” for regulatory and licensing work is:
- NDA application holder (brand authorization)
- FDA “labeler” for each NDC
- FDA-registered manufacturer(s) tied to the labeled NDC
This is the data structure required for supply chain mapping and IP/FD&C Act compliance reviews.
Key Takeaways
- “Supplier” for LARIN FE 1/20 must be defined at NDC level using FDA-registered labeler/manufacturer data.
- Without specific NDC(s) or an Orange Book/NDA record anchor for this strength and presentation, supplier names cannot be stated accurately.
- The correct supplier set can include different manufacturing sites for different package configurations and lot histories.
FAQs
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What is the correct way to identify LARIN FE 1/20 suppliers for procurement?
Match each required pack size to its specific NDC, then read the FDA labeler/manufacturer for that NDC.
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How do I confirm the NDA holder for LARIN FE 1/20?
Use the FDA NDA record and the Orange Book entry tied to the exact NDC(s) for the product.
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Can the manufacturer change without changing the drug name?
Yes. Manufacturing site changes can occur through regulatory supplements while the labeled NDC remains the linkage point.
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Do patent listings affect who can supply LARIN FE 1/20?
They affect generic entry and licensing more than brand labeler/manufacturer obligations, but NDC-level registration still determines actual suppliers.
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Are distributors the same as manufacturers for LARIN FE 1/20?
No. Distributors are part of the wholesale chain; manufacturers and labelers are the FDA-registered supply chain nodes.
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA Drug Label Information and National Drug Code (NDC) Directory. U.S. Food and Drug Administration.
