DrugDashboards

Diclofenac Sodium and Misoprostol

Diclofenac Sodium and Misoprostol · DICLOFENAC SODIUM 50 mg/1; MISOPROSTOL 200 ug/1 · Tablet, Delayed Release · Oral · Amneal Pharmaceuticals LLC

NDC 65162-0436-03 · 30 TABLET, DELAYED RELEASE in 1 BOTTLE · 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 $1.79 per unit over the past year.

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

$0$1.00$2.00$3.00Aug 2017May 2019$1.79
22 price points · per · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

WAC per package, as filed
$76.45
Reported to Texas DSHS · 2023 annual filing · Amneal Pharmaceuticals LLC

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

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 diclofenac sodium and misoprostol (oral solid) 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
ANDA203995
TE code
AB
Approval date
Nov 25, 2016
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 Diclofenac Sodium and Misoprostol (Tablet, Delayed Release)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackDICLOFENAC SODIUM 75 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 3, 2026
Actavis Pharma, Inc.DICLOFENAC SODIUM 50 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.DICLOFENAC SODIUM 75 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCDICLOFENAC SODIUM 50 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCDICLOFENAC SODIUM 75 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
AvKAREDICLOFENAC SODIUM 50 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
AvKAREDICLOFENAC SODIUM 75 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesDICLOFENAC SODIUM 50 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesDICLOFENAC SODIUM 75 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackDICLOFENAC SODIUM 50 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
Nivagen Pharmaceuticals, Inc.DICLOFENAC SODIUM 50 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
Nivagen Pharmaceuticals, Inc.DICLOFENAC SODIUM 75 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPDICLOFENAC SODIUM 50 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPDICLOFENAC SODIUM 75 mg/1; MISOPROSTOL 200 ug/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Diclofenac Sodium and Misoprostol — NDC 65162-0436-03," retrieved September 3, 2026, https://drugdashboards.com/drug/65162043603.

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