Last Updated: June 27, 2026

Suppliers and packagers for OPCICON ONE-STEP


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OPCICON ONE-STEP

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Sun Pharm OPCICON ONE-STEP levonorgestrel TABLET;ORAL 202635 ANDA Ohm Laboratories Inc. 51660-723-11 1 BLISTER PACK in 1 CARTON (51660-723-11) / 1 TABLET in 1 BLISTER PACK 2017-11-01
Sun Pharm OPCICON ONE-STEP levonorgestrel TABLET;ORAL 202635 ANDA Ohm Laboratories Inc. 51660-999-01 1 BLISTER PACK in 1 CARTON (51660-999-01) / 1 TABLET in 1 BLISTER PACK 2017-11-01
Sun Pharm OPCICON ONE-STEP levonorgestrel TABLET;ORAL 202635 ANDA Ohm Laboratories Inc. 51660-999-11 1 BLISTER PACK in 1 CARTON (51660-999-11) / 1 TABLET in 1 BLISTER PACK 2017-11-01
Sun Pharm OPCICON ONE-STEP levonorgestrel TABLET;ORAL 202635 ANDA Sun Pharmaceutical Industries, Inc. 62756-718-60 1 BLISTER PACK in 1 CARTON (62756-718-60) / 1 TABLET in 1 BLISTER PACK 2014-09-12
Sun Pharm OPCICON ONE-STEP levonorgestrel TABLET;ORAL 202635 ANDA SUN PHARMACEUTICAL INDUSTRIES, INC. 62756-720-60 1 BLISTER PACK in 1 CARTON (62756-720-60) / 1 TABLET in 1 BLISTER PACK 2018-04-01
Sun Pharm OPCICON ONE-STEP levonorgestrel TABLET;ORAL 202635 ANDA SUN PHARMACEUTICAL INDUSTRIES, INC. 62756-723-60 1 BLISTER PACK in 1 CARTON (62756-723-60) / 1 TABLET in 1 BLISTER PACK 2017-05-12
Sun Pharm OPCICON ONE-STEP levonorgestrel TABLET;ORAL 202635 ANDA Cardinal Health 110, LLC. DBA Leader 70000-0600-1 1 BLISTER PACK in 1 CARTON (70000-0600-1) / 1 TABLET in 1 BLISTER PACK 2022-03-22
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for OPCICON ONE-STEP

Last updated: June 15, 2026

Suppliers for the Pharmaceutical Drug OPCICON ONE-STEP: Who Makes It, Who Supplies It, and What Inputs Are Covered

OPCICON ONE-STEP is a branded pharmaceutical offering; supplier coverage depends on the drug’s specific composition (active ingredient(s), strength, dosage form) and the licensed product’s labeled manufacturer and contract manufacturing chain. No supplier roster can be produced from the provided input alone.

What company manufactures OPCICON ONE-STEP and who is the labeled drug manufacturer?

A complete supplier answer requires the labeled “manufactured for” / “distributed by” entity and the actual manufacturing site listed on the finished dosage form label or FDA database record for OPCICON ONE-STEP.

Which entities appear on the product label for OPCICON ONE-STEP?

Supplier identification typically resolves into:

  • Finish-dose manufacturer (site and legal entity)
  • Marketer/distributor (labeler)
  • Contract manufacturing organization (CMO) if different from the labeler
  • Contract packaging (secondary packaging and labeling)

How is the manufacturing chain usually structured for a branded OTC/other pharmaceutical product?

Most branded products use a chain of:

  • API supplier (active pharmaceutical ingredient)
  • Intermediate supplier (if applicable)
  • Formulation developer and finished-dose CMO
  • Packaging and distribution providers

What suppliers provide the active pharmaceutical ingredient (API) used in OPCICON ONE-STEP?

API suppliers are contractually and commercially controlled. The API supplier name is only reliably derivable from:

  • The FDA listing entry for the drug’s active ingredient and manufacturer
  • Supplier disclosure in patent filings and manufacturing supplements
  • Public CMC documentation that maps the API manufacturer to the finished product

Does OPCICON ONE-STEP use a single API or multiple actives?

Supplier mapping depends on whether the product is single-API or combination. Combination products multiply the supplier set across each active.

Are there multiple strength or dosage variants that change the supplier?

Different strengths and pack configurations can be produced by different sites, creating different supply contracts.

Who supplies the excipients, packaging, and primary components for OPCICON ONE-STEP?

Packaging and excipients are frequently sourced from different vendors than the API and finished-dose manufacturer.

Which packaging formats drive different suppliers?

Supplier sets change by:

  • Unit-dose vs multi-dose formats
  • Blister vs bottle vs sachet systems
  • Storage conditions (ambient vs refrigerated)
  • Child-resistant and tamper-evident requirements

Which common component categories must be sourced?

At minimum:

  • Primary container closure system
  • Label stock and printing provider
  • Cartoning and secondary packaging provider
  • Desiccant/indicators if needed
  • Serialization and track-and-trace service provider (where applicable)

What does the FDA Orange Book or drug listing data show about OPCICON ONE-STEP suppliers?

Orange Book coverage applies to FDA-approved prescription drugs with approved patents; OTC monographs and many non-Orange-Book products do not.

Does OPCICON ONE-STEP appear in the Orange Book?

If it does, the Orange Book entry typically lists:

  • Applicant/holder
  • Dosage form and route
  • Patent numbers and expiration
  • Exclusivity (if applicable)

If it is not in the Orange Book, what FDA records still identify suppliers?

Other FDA datasets can identify labeled manufacturers, including:

  • Drug product listing (NDC labeler/manufacturer fields)
  • Product label information stored in the drug listing

Which contract manufacturing organizations (CMOs) produce OPCICON ONE-STEP?

Many branded products are produced by CMOs under private-label or contract manufacturing agreements. The legal manufacturing entity and site are what determine the CMO supplier.

How to identify the producing site for OPCICON ONE-STEP?

The most reliable public method is the manufacturing site listed in the drug product label or FDA listing record. Without the product identifier (NDC, strength, dosage form), supplier identification cannot be made correctly.

What do patent filings for OPCICON ONE-STEP reveal about the supplier network?

Patents can mention:

  • API synthesis routes and starting materials
  • Formulation components and processes
  • Manufacturing steps and site-related process know-how

But supplier names are not consistently disclosed, especially for routine CMO production.

Which patent holder and assignee link most often to supplier disclosures?

Assignees and named inventors do not always map to actual manufacturers. The strongest link is the company listed in:

  • Regulatory filings (application/labeler)
  • CMC sections
  • Manufacturing site identifiers

Which distribution partners supply OPCICON ONE-STEP to wholesalers and pharmacies?

Distribution is typically separated into:

  • Wholesale distributor of record
  • Specialty distributor (if applicable)
  • Regional logistics partners

These are listed via company disclosures and sales channels, not from product branding alone.

Does the supply chain differ by channel (retail vs hospital vs mail order)?

Yes. Hospital and institutional channels often add a specialty or group purchasing organization layer, with different fulfillment partners.

Key Takeaways

  • A supplier list for OPCICON ONE-STEP cannot be generated from the provided prompt because “OPCICON ONE-STEP” alone is not enough to identify the labeled manufacturer, NDC-drug listing record, API manufacturer, or manufacturing sites.
  • Supplier identification requires the product’s exact regulatory identifier and labeled drug composition to map to:
    • Finished-dose manufacturer and site
    • API and intermediate suppliers
    • Packaging providers
    • Distributor-of-record partners

FAQs

  1. What document shows the labeled manufacturer for OPCICON ONE-STEP?
  2. How do I identify the API supplier for a branded drug like OPCICON ONE-STEP?
  3. Do different strengths of the same product use different manufacturing sites?
  4. Where can contract packaging suppliers be found in public records?
  5. How do FDA drug listing entries map to the manufacturer and labeler for OPCICON ONE-STEP?

More… ↓

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