Last Updated: September 24, 2026

Suppliers and packagers for NORTREL 1/35-28


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NORTREL 1/35-28

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Barr Labs NORTREL 1/35-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 072696 ANDA Teva Pharmaceuticals USA, Inc. 0555-9010-58 6 POUCH in 1 CARTON (0555-9010-58) / 1 BLISTER PACK in 1 POUCH (0555-9010-79) / 1 KIT in 1 BLISTER PACK 2001-06-06
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Who Supplies NORTREL 1/35-28?

Last updated: April 27, 2026

No complete, accurate supplier roster can be produced from the information provided.

What is NORTREL 1/35-28?

NORTREL 1/35-28 is a branded oral contraceptive. The label “1/35-28” indicates a combined oral contraceptive regimen with 1 mg norethindrone acetate (progestin) and 35 mcg ethinyl estradiol (estrogen) delivered on a 28-day cycle.

Who are the suppliers?

A “supplier” list requires identifying at least one of the following with defensible sourcing:

  • Drug product manufacturer (marketing authorization holder / NDA holder)
  • GMP manufacturer(s) of the finished dosage form
  • Marketing authorization labeling company / distributor
  • Active ingredient suppliers (APIs)
  • NDC-linked product listing with manufacturer and labeler identity

The input provided includes only the product name and strength regimen, with no manufacturer, labeler, NDC, application type, or regulatory listing identifiers. Without those, a supplier mapping would be incomplete and risk publishing incorrect entities.

Where supplier identities usually come from (regulatory traceability)

Supplier identification is normally anchored to:

  • FDA Orange Book (NDA holder and drug product manufacturer associations)
  • FDA NDC Directory (labeler and product mapping)
  • FDA Drug Label (Structured Product Labeling) (labeler/manufacturer names)

None of these identifiers are present in the prompt.

What can be concluded from the name alone

“NORTREL 1/35-28” alone is not a reliable key for mapping to specific suppliers across:

  • geographic markets,
  • historical brand assignments,
  • relabeling events,
  • contract manufacturing changes.

Key Takeaways

  • The product identifier NORTREL 1/35-28 is not sufficient to generate a complete and accurate supplier list.
  • Supplier rosters require regulatory identifiers (NDC, NDA, labeler, or manufacturer fields) to avoid misattribution.

FAQs

1) What does “1/35-28” mean in NORTREL 1/35-28?
It denotes 1 mg progestin, 35 mcg estrogen, and a 28-day dosing cycle.

2) Can I list suppliers using only the brand name?
No. Brand names can map to multiple labelers or manufacturers over time, and “supplier” needs regulatory-grade identifiers.

3) What sources typically identify the finished-dose manufacturer?
FDA Orange Book, NDC Directory, and FDA drug label manufacturer/labeler fields.

4) Are API suppliers included in typical brand-level public listings?
Sometimes, but API supplier attribution is often not explicit at brand level and may require separate sourcing records.

5) What single data point would usually unlock a supplier list?
An NDC or NDA tied to the exact dosage form and strength.

References

[1] U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] U.S. FDA. NDC Directory.
[3] U.S. FDA. Drugs@FDA (drug label and application information).

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