Last updated: May 5, 2026
JUNEL 1.5/30 is a fixed-dose combination oral contraceptive tablet (norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg). The market supply is tied to the brand’s original U.S. sponsor and its authorized manufacturing network, plus generic manufacturers that sell bioequivalent equivalents under ANDA approvals.
Who are the suppliers by brand vs. generic?
Brand supply (JUNEL 1.5/30)
- Sponsor / marketing company (U.S.): Pfizer Inc. (brand ownership and labeling authority for JUNEL products).
Source: FDA Orange Book listing for JUNEL 1.5/30 (norethindrone acetate/ethinyl estradiol) shows Pfizer as the applicant/holder of record. [1]
Generic supply (ANDA equivalents)
Generic versions of norethindrone acetate 1.5 mg / ethinyl estradiol 30 mcg are supplied by multiple ANDA holders. The suppliers are the ANDA applicants listed in the FDA Orange Book for the specific strength and dosage form (oral tablet) and match the brand’s active ingredient set and strength.
- Generic suppliers: ANDA applicants shown on FDA Orange Book for “Norethindrone Acetate 1.5 mg and Ethinyl Estradiol 0.03 mg” oral tablets. [1]
Practical procurement implication: if you source “JUNEL 1.5/30” specifically, you are buying Pfizer brand product; if you source the actives/strength under “bioequivalent to JUNEL 1.5/30,” you are buying from the ANDA applicant/manufacturer network listed on the Orange Book.
What exactly does “JUNEL 1.5/30” correspond to in regulatory terms?
| Item |
Regulatory descriptor |
Strength (per tablet) |
| Drug |
Fixed-dose oral contraceptive combination |
Norethindrone acetate 1.5 mg / Ethinyl estradiol 30 mcg |
| FDA Orange Book match key |
Active ingredients and strength |
Norethindrone Acetate 1.5 mg + Ethinyl Estradiol 0.03 mg (oral tablet) |
Source: FDA Orange Book drug record for JUNEL 1.5/30. [1]
How to identify the actual manufacturing “supplier” behind the product you buy
“Supplier” can mean two different things in pharma procurement:
- Brand sponsor/holder of record (the company accountable for the NDA/labeling).
- Manufacturer of the finished dosage form (the labeled manufacturing sites).
FDA Orange Book records provide the applicant/holder and, depending on the listing, may also show relevant details that procurement teams use to map to manufacturers and packers.
For brand JUNEL 1.5/30, the holder is Pfizer Inc. [1]
For generic equivalents, each ANDA applicant listed in Orange Book is the supplier category that maps to the ANDA manufacturing and distribution chain. [1]
Suppliers list (what can be stated from authoritative listings)
Confirmed brand supplier (holder/labeling authority)
- Pfizer Inc. (JUNEL 1.5/30 holder/applicant on FDA Orange Book). [1]
Confirmed generic supplier universe (Orange Book applicants)
- ANDA applicants listed in FDA Orange Book for the exact combination and strength of norethindrone acetate 1.5 mg / ethinyl estradiol 30 mcg oral tablets. [1]
Because supplier names for the generic universe are dataset-specific and must be taken exactly from the Orange Book listing for that strength and dosage form, the authoritative way to enumerate “all suppliers” is to use the Orange Book applicant list for that record. [1]
Key Takeaways
- Pfizer is the confirmed brand supplier/holder for JUNEL 1.5/30 in the U.S. as shown in the FDA Orange Book record. [1]
- Generic suppliers are the ANDA applicants listed on the FDA Orange Book for norethindrone acetate 1.5 mg / ethinyl estradiol 30 mcg oral tablets. [1]
- Procurement teams should treat “supplier” as either holder of record (brand) or ANDA applicant (generic), then map to finished-dose manufacturer sites using the specific Orange Book entry and label/DSCSA documentation. [1]
FAQs
1) Who makes the brand JUNEL 1.5/30 in the U.S.?
Pfizer Inc. is the holder/applicant for JUNEL 1.5/30 in the FDA Orange Book. [1]
2) Are there multiple companies supplying generic JUNEL 1.5/30?
Yes. Generic supply comes from multiple ANDA applicants listed in the FDA Orange Book for the same active ingredient combination and strength. [1]
3) What are the active ingredients and strengths for JUNEL 1.5/30?
Norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg per tablet. [1]
4) How do you confirm the supplier list for generic equivalents?
Use the FDA Orange Book entries for the exact combination and dosage form, and take the ANDA applicants listed for that record. [1]
5) Does the Orange Book supplier indicate the finished dosage manufacturer site?
Orange Book is the authoritative starting point for holder/applicant mapping; the finished-dose manufacturing site may require checking the specific record details and/or labeling/DSCSA documentation tied to that product. [1]
References
[1] U.S. Food and Drug Administration. (n.d.). FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Record for JUNEL 1.5/30: norethindrone acetate 1.5 mg / ethinyl estradiol 30 mcg). https://www.accessdata.fda.gov/scripts/cder/daf/ (access via Orange Book search)
