DrugDashboards

Carbamazepine

carbamazepine · CARBAMAZEPINE 200 mg/1 · Capsule, Extended Release · Oral · Coupler LLC

NDC 67046-1559-03 · 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK · ANDA · View full market →

The short version

9 companies supply this market — a reasonable cushion if one runs into trouble.

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 54092-0172-12) — 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
$1.40per unit
middle half $1.38$1.79 · 117 plans · Apr 1, 2026
Est. net of rebates
≈ $1.40
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
2%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 carbamazepine (oral solid) in the next 90 days

sole-source market · 1 Class I/II recall(s) in 12 months

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
ANDA076697
TE code
AB
Approval date
May 20, 2011
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Carbatrol, Capsule, Extended Release, 100 mg (NDC 54092-171-12)Dec 19, 2025
  • Planned discontinuation Carbatrol, Capsule, Extended Release, 200 mg (NDC 54092-172-12)Dec 19, 2025
  • Planned discontinuation Carbatrol, Capsule, Extended Release, 300 mg (NDC 54092-173-12)Dec 19, 2025

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of carbamazepine (Capsule, Extended Release)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackCARBAMAZEPINE 200 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackCARBAMAZEPINE 300 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackCARBAMAZEPINE 100 mg/1Jul 15, 2026Sep 3, 2026
ANI Pharmaceuticals, Inc.CARBAMAZEPINE 300 mg/1Jul 15, 2026Sep 2, 2026
ANI Pharmaceuticals, Inc.CARBAMAZEPINE 100 mg/1Jul 15, 2026Sep 2, 2026
ANI Pharmaceuticals, Inc.CARBAMAZEPINE 200 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.CARBAMAZEPINE 300 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.CARBAMAZEPINE 100 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.CARBAMAZEPINE 200 mg/1Jul 15, 2026Sep 2, 2026
AvPAKCARBAMAZEPINE 100 mg/1Jul 15, 2026Sep 2, 2026
AvPAKCARBAMAZEPINE 200 mg/1Jul 15, 2026Sep 2, 2026
AvPAKCARBAMAZEPINE 300 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCCARBAMAZEPINE 200 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCCARBAMAZEPINE 100 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCCARBAMAZEPINE 300 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsCARBAMAZEPINE 200 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.CARBAMAZEPINE 300 mg/1Jul 15, 2026Sep 2, 2026
Takeda Pharmaceuticals America, Inc.CARBAMAZEPINE 300 mg/1Jul 15, 2026Sep 2, 2026
Takeda Pharmaceuticals America, Inc.CARBAMAZEPINE 200 mg/1Jul 15, 2026Sep 2, 2026
Takeda Pharmaceuticals America, Inc.CARBAMAZEPINE 100 mg/1Jul 15, 2026Sep 2, 2026
Validus Pharmaceuticals LLCCARBAMAZEPINE 200 mg/1Jul 15, 2026Sep 2, 2026
Validus Pharmaceuticals LLCCARBAMAZEPINE 100 mg/1Jul 15, 2026Sep 2, 2026
Validus Pharmaceuticals LLCCARBAMAZEPINE 300 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Carbamazepine — NDC 67046-1559-03," retrieved September 3, 2026, https://drugdashboards.com/drug/67046155903.

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