Last updated: July 24, 2026
Nortrel 0.5/35-28 Suppliers: Who Manufactures and Supplies This Oral Contraceptive?
Nortrel 0.5/35-28 is an oral contraceptive containing norethindrone 0.5 mg + ethinyl estradiol 35 mcg in a 28-day blister pack. Supplier coverage is determined by (1) the FDA Orange Book label/manufacturer listings for the specific strength and dosage form and (2) whether distribution is direct from the NDA holder or through authorized wholesalers, repackagers, or contract manufacturers.
What companies supply Nortrel 0.5/35-28 to pharmacies and wholesalers?
Answer (Orange Book-driven sourcing): Sufficient, specific Orange Book labeler/manufacturer data is not available in the provided information to identify the exact supplier companies for Nortrel 0.5/35-28.
What counts as a “supplier” for this drug
For business and procurement decisions, “supplier” typically maps to one or more of:
- Labeler / NDA holder shown on the FDA Orange Book (the entity responsible for the approved drug product label).
- GDUFA/CMC manufacturing site and listed manufacturers for the dosage form (if separately disclosed on FDA records).
- Wholesalers that stock the product (often multiple, including McKesson, Cardinal, AmerisourceBergen, and regional distributors).
- Contract manufacturers producing on behalf of the NDA holder (not always visible at the retail “labeler” level).
Because Nortrel product codes change across NDC formats and packaging, accurate supplier identification requires the exact NDC(s) tied to 0.5/35-28.
What is the Orange Book status of Nortrel 0.5/35-28 and who is the labeler?
Answer: Insufficient input data is provided to determine the Orange Book labeler and listing status for Nortrel 0.5/35-28.
What the Orange Book typically provides for oral contraceptives
For each relevant listing, the Orange Book record usually includes:
- NDA number
- Dosage form and strength
- Applicant/Labeler
- Marketing status (e.g., Rx only, discontinued, discontinued but with retained listing)
- Patent and exclusivity links for the listed NDA (rarely decisive for suppliers, but decisive for litigation posture)
Which suppliers manufacture norethindrone 0.5 mg / ethinyl estradiol 35 mcg 28-day packs?
Answer: The supplier set cannot be enumerated without the exact Nortrel 0.5/35-28 NDC numbers linked to the 28-day pack.
Common supplier patterns for contraceptive brands
Even when labelers are known, manufacturers can vary by:
- Site of manufacture (multiple approved sites)
- Packaging configuration (21 vs 28 tablets, different blister SKUs)
- 28-day calendar pack barcodes
- Market discontinuations and relaunches
For procurement, this matters because “same active ingredients” does not equal “same supplier,” even within the same brand.
How do distributors typically source Nortrel 0.5/35-28 if multiple NDCs exist?
Answer: Insufficient information is provided to map specific NDC-to-distributor supply chains for Nortrel 0.5/35-28.
Procurement-impacting constraints
- Inventory is NDC-specific, not strength-only.
- If Nortrel has been reformatted or re-labeled, pharmacies often substitute by NDC equivalence.
- Distributors carry whichever NDCs are currently market-active in the U.S., which can shift by lot release or marketing status.
What generic or AB-rated alternatives compete with Nortrel 0.5/35-28 and who supplies them?
Answer: No competitor list can be generated without establishing the AB/RLD mapping for the precise Nortrel 0.5/35-28 listing.
Why this can’t be inferred from the label name alone
For oral contraceptives, FDA AB-rating is determined by:
- Active ingredients and dose
- Tablet schedule configuration (28-day packs)
- Specific NDC mapping within the Orange Book entry
Without the Orange Book listing identifier, supplier comparisons across generics risk being incorrect.
Key Takeaways
- Nortrel 0.5/35-28 is a norethindrone/ethinyl estradiol 28-day oral contraceptive.
- Identifying the exact supplier companies requires Orange Book labeler/manufacturer records tied to the specific NDC(s) for Nortrel 0.5/35-28.
- No supplier roster can be reliably produced from the provided input alone.
FAQs
- What NDCs correspond to Nortrel 0.5/35-28?
- Who is the Orange Book applicant/labeler for Nortrel 0.5/35-28?
- Is Nortrel 0.5/35-28 currently marketed or discontinued?
- Which wholesalers distribute Nortrel 0.5/35-28 in the U.S.?
- What AB-rated generics are tied to the Nortrel 0.5/35-28 listing?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book).
