DrugDashboards

Balcoltra

levonorgestrel and ethinyl estradiol · Kit · Avion Pharmaceuticals

NDC 75854-0602-02 · 2 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK · NDA · View full market →

The short version

17 companies supply this market — deep enough that no single failure threatens the supply.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 16714-0359-04) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$0.2123per unit
middle half $0.2050$0.3353 · 5,024 plans · Apr 1, 2026
Est. net of rebates
$0.1274–$0.1592
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
91%of plans cover it
tier 2 · prior auth 0% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for levonorgestrel and ethinyl estradiol (other) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
NDA208612
TE code
AB3
Approval date
Jan 9, 2018
Patents / exclusivity
1 patents, 0 exclusivities
TypeNumber / codeExpires
patent7838042Jun 1, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of levonorgestrel and ethinyl estradiol (Kit)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsJul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedJul 15, 2026Sep 3, 2026
Glenmark Pharmaceuticals Inc., USAJul 15, 2026Sep 3, 2026
Lupin Pharmaceuticals, Inc.Jul 15, 2026Sep 3, 2026
Northstar Rx LLCJul 15, 2026Sep 3, 2026
Teva Pharmaceuticals USA, Inc.Jul 15, 2026Sep 3, 2026
Xiromed, LLC.Jul 15, 2026Sep 3, 2026
Acella PharmaceuticalsJul 15, 2026Sep 2, 2026
Avion PharmaceuticalsJul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories Inc.Jul 15, 2026Sep 2, 2026
Exeltis USA, Inc.Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.Jul 15, 2026Sep 2, 2026
Proficient Rx LPJul 15, 2026Sep 2, 2026
Afaxys Pharma, LLCJul 15, 2026Aug 31, 2026
Bryant Ranch PrepackJul 15, 2026Aug 31, 2026
Naari Pte LimitedJul 15, 2026Aug 31, 2026
Apotex Corp.Jul 15, 2026Aug 16, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Balcoltra — NDC 75854-0602-02," retrieved September 3, 2026, https://drugdashboards.com/drug/75854060202.

Free to cite with attribution — see how the data is put together.