The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Cysteine Hydrochloride
cysteine hydrochloride · CYSTEINE HYDROCHLORIDE 34.5 mg/mL · Injection · Intravenous · Baxter Healthcare Corporation
NDC 00338-9645-01 · 5 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE · NDA · View full market →
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.
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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA212535
- TE code
- —
- Approval date
- Dec 13, 2019
- Patents / exclusivity
- 20 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 10702490 | Mar 15, 2039 |
| patent | 11045438 | Mar 15, 2039 |
| patent | 10493051 | Mar 15, 2039 |
| patent | 10543186 | Mar 15, 2039 |
| patent | 11510941 | Mar 2, 2039 |
| patent | 10905714 | Jan 15, 2039 |
| patent | 11642370 | Jan 15, 2039 |
| patent | 10918662 | Jan 15, 2039 |
| patent | 12569514 | Jan 15, 2039 |
| patent | 11648262 | Jan 15, 2039 |
| patent | 11679125 | Jan 15, 2039 |
| patent | 10653719 | Jan 15, 2039 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of cysteine hydrochloride (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Baxter Healthcare Corporation | CYSTEINE HYDROCHLORIDE 34.5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Cysteine Hydrochloride — NDC 00338-9645-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00338964501.
Free to cite with attribution — see how the data is put together.