DrugDashboards

Xulane

norelgestromin and ethinyl estradiol · NORELGESTROMIN 150 ug/d; ETHINYL ESTRADIOL 35 ug/d · Patch · Transdermal · Mylan Pharmaceuticals Inc.

NDC 00378-3340-53 · 3 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 7 d in 1 PATCH · ANDA · View full market →

The short version

7 companies supply this market — a reasonable cushion if one runs into trouble. The price has held steady around $36.70 per unit over the past year. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

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

  • Pharmacies pay (NADAC)$36.70per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$28.00per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$31.20per unitnegotiated price across 4,908 plans — before rebates · Apr 1, 2026
  • Federal contracts pay (FSS)$30.00per unitMylan Pharmaceuticals, Inc. · Jan 1, 202682% of what pharmacies pay — a deeper discount than 57% of drugs with this benchmark

Medicare Part D

All Part D pricing →
ⓘ 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
$31.20per unit
middle half $22.91$37.51 · 4,908 plans · Apr 1, 2026
Est. net of rebates
≈ $31.20
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
89%of plans cover it
tier 3 · prior auth 0% · step therapy 0% · qty limit 25%

*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

$0$20.00$40.00$60.00Jul 2014Sep 2026$36.70
87 price points · per EASource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$122.15
Reported to Texas DSHS · 2026 annual filing · Mylan Pharmaceuticals Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2025)

$37.7M
246,827 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

0Low risk

Nothing here is signaling trouble: several manufacturers, no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for norelgestromin 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 →

Regulatory

Application
ANDA200910
TE code
AB
Approval date
Apr 16, 2014
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of norelgestromin and ethinyl estradiol (Patch)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsNORELGESTROMIN 150 ug/d; ETHINYL ESTRADIOL 35 ug/dAug 26, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCNORELGESTROMIN 150 ug/d; ETHINYL ESTRADIOL 35 ug/dAug 26, 2026Sep 2, 2026
AvKARENORELGESTROMIN 150 ug/d; ETHINYL ESTRADIOL 35 ug/dAug 26, 2026Sep 2, 2026
Bryant Ranch PrepackNORELGESTROMIN 150 ug/d; ETHINYL ESTRADIOL 35 ug/dAug 26, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.NORELGESTROMIN 150 ug/d; ETHINYL ESTRADIOL 35 ug/dAug 26, 2026Sep 2, 2026
Zydus Lifesciences LimitedNORELGESTROMIN 150 ug/mg; ETHINYL ESTRADIOL 35 ug/mgAug 26, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.NORELGESTROMIN 150 ug/mg; ETHINYL ESTRADIOL 35 ug/mgAug 26, 2026Sep 2, 2026
A-S Medication SolutionsNORELGESTROMIN 35 ug/d; ETHINYL ESTRADIOL 150 ug/dJul 22, 2026Aug 19, 2026
Amneal Pharmaceuticals LLCNORELGESTROMIN 35 ug/d; ETHINYL ESTRADIOL 150 ug/dJul 22, 2026Aug 19, 2026
AvKARENORELGESTROMIN 35 ug/d; ETHINYL ESTRADIOL 150 ug/dJul 22, 2026Aug 19, 2026
Bryant Ranch PrepackNORELGESTROMIN 35 ug/d; ETHINYL ESTRADIOL 150 ug/dJul 22, 2026Aug 19, 2026
Mylan Pharmaceuticals Inc.NORELGESTROMIN 35 ug/d; ETHINYL ESTRADIOL 150 ug/dJul 22, 2026Aug 19, 2026
Zydus Lifesciences LimitedNORELGESTROMIN 35 ug/mg; ETHINYL ESTRADIOL 150 ug/mgJul 22, 2026Aug 19, 2026
Zydus Pharmaceuticals USA Inc.NORELGESTROMIN 35 ug/mg; ETHINYL ESTRADIOL 150 ug/mgJul 22, 2026Aug 19, 2026
A-S Medication SolutionsETHINYL ESTRADIOL 35 ug/d; NORELGESTROMIN 150 ug/dJul 15, 2026Jul 15, 2026
Amneal Pharmaceuticals LLCETHINYL ESTRADIOL 35 ug/d; NORELGESTROMIN 150 ug/dJul 15, 2026Jul 15, 2026
AvKAREETHINYL ESTRADIOL 35 ug/d; NORELGESTROMIN 150 ug/dJul 15, 2026Jul 15, 2026
Bryant Ranch PrepackETHINYL ESTRADIOL 35 ug/d; NORELGESTROMIN 150 ug/dJul 15, 2026Jul 15, 2026
Mylan Pharmaceuticals Inc.ETHINYL ESTRADIOL 35 ug/d; NORELGESTROMIN 150 ug/dJul 15, 2026Jul 15, 2026
Zydus Lifesciences LimitedETHINYL ESTRADIOL 35 ug/mg; NORELGESTROMIN 150 ug/mgJul 15, 2026Jul 15, 2026
Zydus Pharmaceuticals USA Inc.ETHINYL ESTRADIOL 35 ug/mg; NORELGESTROMIN 150 ug/mgJul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Xulane — NDC 00378-3340-53," retrieved September 3, 2026, https://drugdashboards.com/drug/00378334053.

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