DrugDashboards

Fulvestrant

fulvestrant · FULVESTRANT 50 mg/mL · Injection, Solution · Intramuscular · Zydus Lifesciences Limited

NDC 70771-1626-08 · 2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS · ANDA · View full market →

The short version

11 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

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

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.

Where it's made

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

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $691.92 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA215234
TE code
AO
Approval date
Jul 29, 2021
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Fulvestrant, Injection, 250 mg per 5mL (NDC 63323-715-05)Aug 14, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of fulvestrant (Injection, Solution)

LabelerStrengthFirst seenLast seen
Sagent PharmaceuticalsFULVESTRANT 50 mg/mLJul 15, 2026Sep 3, 2026
Athenex Pharmaceutical Division, LLC.FULVESTRANT 50 mg/mLJul 15, 2026Sep 2, 2026
Avenacy, Inc.FULVESTRANT 50 mg/mLJul 15, 2026Sep 2, 2026
BluePoint LaboratoriesFULVESTRANT 250 mg/5mLJul 15, 2026Sep 2, 2026
Dr.Reddy's Laboratories IncFULVESTRANT 50 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCFULVESTRANT 50 mg/mLJul 15, 2026Sep 2, 2026
Northstar Rx, LLC,FULVESTRANT 50 mg/mLJul 15, 2026Sep 2, 2026
Xiromed, LLCFULVESTRANT 50 mg/mLJul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedFULVESTRANT 50 mg/mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.FULVESTRANT 50 mg/mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCFULVESTRANT 250 mg/5mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Fulvestrant — NDC 70771-1626-08," retrieved September 3, 2026, https://drugdashboards.com/drug/70771162608.

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