DrugDashboards

Premasol - sulfite-free (Amino Acid)

Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-Acetyl-Tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride · LEUCINE 1.4 g/100mL; LYSINE ACETATE .82 g/100mL; ISOLEUCINE .82 g/100mL; VALINE .78 g/100mL; HISTIDINE .48 g/100mL; PHENYLALANINE .48 g/100mL; THREONINE .42 g/100mL; METHIONINE .34 g/100mL; TRYPTOPHAN .2 g/100mL; TYROSINE .24 g/100mL; ARGININE 1.2 g/100mL; PROLINE .68 g/100mL; ALANINE .54 g/100mL; GLUTAMIC ACID .5 g/100mL; SERINE .38 g/100mL; GLYCINE .36 g/100mL; ASPARTIC ACID .32 g/100mL; TAURINE 25 mg/100mL; CYSTEINE HYDROCHLORIDE .016 g/100mL · Injection, Solution · Intravenous · Baxter Healthcare Company

NDC 00338-1130-04 · 1000 mL in 1 BAG · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. It is in shortage right now. One of its named manufacturing plants, Baxter Healthcare Corporation, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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 00338-1130-03) — 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
$0.1097per unit
middle half $0.1082$0.1130 · 4,577 plans · Apr 1, 2026
Est. net of rebates
≈ $0.1097
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
83%of plans cover it
tier 5 · prior auth 97% · 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.

Estimated fill cost

WAC per package, as filed
$100.28
Reported to Texas DSHS · 2026 annual filing · Baxter Healthcare Corporation

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

Medicaid spend (2025)

$84,598
359 prescriptions paid by Medicaid nationally · all Medicaid spend →

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
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA075880
TE code
Approval date
Jun 19, 2003
Patents / exclusivity
None on file

Shortage history

  • In shortage now Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-03)Dec 8, 2020
    month 69 — 3× the typical 20-month injectable shortage
  • In shortage now Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-04)Dec 8, 2020
    month 69 — 3× the typical 20-month injectable shortage
  • In shortage now Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-06)Dec 8, 2020
    month 69 — 3× the typical 20-month injectable shortage

Recalls (this NDC)

  • Class II · TerminatedDec 6, 2016
    Baxter Healthcare CorporationDiscoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.

Manufacturers of Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-Acetyl-Tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Baxter Healthcare CompanyLEUCINE 1.4 g/100mL; LYSINE ACETATE .82 g/100mL; ISOLEUCINE .82 g/100mL; VALINE .78 g/100mL; HISTIDINE .48 g/100mL; PHENYLALANINE .48 g/100mL; THREONINE .42 g/100mL; METHIONINE .34 g/100mL; TRYPTOPHAN .2 g/100mL; TYROSINE .24 g/100mL; ARGININE 1.2 g/100mL; PROLINE .68 g/100mL; ALANINE .54 g/100mL; GLUTAMIC ACID .5 g/100mL; SERINE .38 g/100mL; GLYCINE .36 g/100mL; ASPARTIC ACID .32 g/100mL; TAURINE 25 mg/100mL; CYSTEINE HYDROCHLORIDE .016 g/100mLAug 26, 2026Sep 2, 2026
Baxter Healthcare CompanyLEUCINE .54 g/100mL; LYSINE ACETATE 1.2 g/100mL; ISOLEUCINE .32 g/100mL; VALINE .016 g/100mL; HISTIDINE .5 g/100mL; PHENYLALANINE .36 g/100mL; THREONINE .48 g/100mL; METHIONINE .82 g/100mL; TRYPTOPHAN 1.4 g/100mL; TYROSINE .82 g/100mL; ARGININE .34 g/100mL; PROLINE .48 g/100mL; ALANINE .68 g/100mL; GLUTAMIC ACID .38 g/100mL; SERINE 25 mg/100mL; GLYCINE .42 g/100mL; ASPARTIC ACID .2 g/100mL; TAURINE .24 g/100mL; CYSTEINE HYDROCHLORIDE .78 g/100mLJul 22, 2026Aug 19, 2026
Baxter Healthcare CompanyALANINE .54 g/100mL; ARGININE 1.2 g/100mL; ASPARTIC ACID .32 g/100mL; CYSTEINE HYDROCHLORIDE .016 g/100mL; GLUTAMIC ACID .5 g/100mL; GLYCINE .36 g/100mL; HISTIDINE .48 g/100mL; ISOLEUCINE .82 g/100mL; LEUCINE 1.4 g/100mL; LYSINE ACETATE .82 g/100mL; METHIONINE .34 g/100mL; PHENYLALANINE .48 g/100mL; PROLINE .68 g/100mL; SERINE .38 g/100mL; TAURINE 25 mg/100mL; THREONINE .42 g/100mL; TRYPTOPHAN .2 g/100mL; TYROSINE .24 g/100mL; VALINE .78 g/100mLJul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Premasol - sulfite-free (Amino Acid) — NDC 00338-1130-04," retrieved September 3, 2026, https://drugdashboards.com/drug/00338113004.

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