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Prolastin-C Liquid Alpha1-Proteinase Inhibitor (Human) 1000 mg/20mL Injection, Solution — NDC 13533-0705-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Prolastin-C Liquid Alpha1-Proteinase Inhibitor (Human) 1000 mg/20mL Injection, Solution — NDC 13533-705-01 (Billing 13533-0705-01)

by GRIFOLS USA, LLC · 1 VIAL in 1 CARTON / 20 mL in 1 VIAL

This is a package of Prolastin-C Liquid Alpha1-Proteinase Inhibitor (Human) 1000 mg/20mL Injection, Solution from GRIFOLS USA, LLC, marketed since Dec 1987 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 13533-0705-01
🏷️ FDA NDC (as labeled) 13533-705-01 billing pads the product segment with a zero
This package
Contains20 mL in 1 vial Medicaid pays$0.5430 / unit · 12 mo Per package$10.86 / 20 ml · Medicaid Pack sizes3 compare ↓
Also priced by: Part D plans $0.6181/unit — full pricing hub ↓
Main listing for product 13533-705 · Also comes in: 10 mL 13533-705-31 80 mL 13533-705-51
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 13533-705-01 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
13533 labeler · 705 product · 01 package
Package marketed since
Dec 2, 1987
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1353370501 5
Medicaid fills, this package
4,385 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 13533-705-01
Product NDC 13533-705
11-digit billing NDC 13533070501
NCPDP billing unit EA — each (per item)
Application # BLA103174
SPL Set ID 2b620e6b-6a24-0957-1288-ae529c4cc3a2
Established class (EPC) Human alpha-1 Proteinase Inhibitor
Mechanism of action Trypsin Inhibitors
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1987-12-02
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance .ALPHA.1-PROTEINASE INHIBITOR HUMAN
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 45100010102015
GPI class Prolastin-C
GCN Seq No 078055
GCN 44288
HICL code 004529
Ingredient (HICL) Alpha-1-Proteinase Inhibitor
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2H
Therapeutic class — specific (HIC3) Systemic Enzyme Inhibitors
AHFS code 16:00.00.00
AHFS class Blood Derivatives
FDB label name PROLASTIN C 1,000 MG/20 ML VL
FDB brand name Prolastin C
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 078055
  • GCN: 44288
  • GPI-14 (Medi-Span): 45100010102015
  • HICL (First Databank): 004529
  • AHFS class code: 16:00.00.00
Why two NDCs? The FDA registers this code as 13533-705-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 13533-0705-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name PROLASTIN C 1,000 MG/20 ML VL Ingredient Alpha-1-Proteinase Inhibitor
📖 What it is MedlinePlus · NLM

Alpha-1-proteinase inhibitor is used in people with symptoms of emphysema (a lung disease) and alpha-1 antitrypsin deficiency (AATD). AATD is an inherited condition in which the body does not make enough of a protein (alpha-1 antitrypsin) needed to protect the lungs from smoke, dust, or pollution. Alpha-1-proteinase inhibitor is in a class of medications called blood derivatives. It works by increasing the levels of alpha-1 antitrypsin protein in your blood and lungs.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.5430 $10.86 / 20 ml
Medicare drug plans payPart D · Q2 2026 $0.6181 $12.36 / 20 ml
Medicare Part B allowsASP · J0256 $5.133 / J0256 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)13533-705-01
11-digit billing NDC13533-0705-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0256
DescriptorINJECTION, ALPHA 1 PROTEINASE INHIBITOR (HUMAN), NOT OTHERWISE SPECIFIED, 10 MG
Billing units / pkg0.1 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 10 MG, so one package = 0.1 billing units.
Medicare Part B spend (2026 (Q1))$31,722,276 · 9,390 claims · $3,378.30 per claim (all NDCs under J0256)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
13533-0705-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 20 mL in 1 VIAL 1987-12-02 — Active
13533-0705-31 13533-705-31 1 VIAL in 1 CARTON / 10 mL in 1 VIAL 1987-12-02 — Active
13533-0705-51 13533-705-51 1 VIAL in 1 CARTON / 80 mL in 1 VIAL 1987-12-02 — Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial in 1 carton / 20 ml in 1 vial.
What NDC number is used to bill for this package of Prolastin-C Liquid Alpha1-Proteinase Inhibitor (Human) 1000 mg/20mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Prolastin-C Liquid 1000 mg/20mLthis 13533-0705-01 GRIFOLS 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
1987
First FDA approval
Dec 1987
📍
2026
Currently FDA-listed
39 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

What it looks like

Color Yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OF5P57N2ZX
    Alanine is a naturally occurring amino acid used in medicines as a buffering agent and pH stabilizer. It helps maintain the proper acidity level in liquid formulations to improve stability and taste.
  • UNII SE337SVY37
    A mineral salt used as a buffer to help maintain the medicine's pH level and prevent breakdown of active ingredients. It also acts as a thickening agent in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGRIFOLS USA, LLC
FDA applicationBLA103174 (BLA)
Labeler code13533
First marketedDec 1987
Product typePlasma Derivative
Portfolio52 products on file

More NDCs from GRIFOLS USA, LLC labeler code 13533

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.4K
Units reimbursed last 4 qtrs
56.6M
Gross reimbursed last 4 qtrs
$30.75M
Avg / prescription
$7,013.60
Avg / unit
$0.5430
Latest quarter Q1 2026
921Rx
Fee-for-service vs managed care ⓘ
40% FFS 60% MCO
Fee-for-service · 1,764 Rx Managed care · 2,621 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,528,576 units · 109,575 per 100k residents ME Washington: no data reported WA Idaho: 197,648 units · 10,064 per 100k residents ID Montana: 201,613 units · 17,810 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 477,304 units · 8,076 per 100k residents WI Michigan: 2,586,581 units · 25,770 per 100k residents MI New York: 4,130,552 units · 21,105 per 100k residents NY Vermont: 862,844 units · 133,361 per 100k residents VT New Hampshire: no data reported NH Oregon: 298,458 units · 7,051 per 100k residents OR Nevada: no data reported NV Wyoming: 158,830 units · 27,197 per 100k residents WY South Dakota: no data reported SD Iowa: 3,330,254 units · 103,843 per 100k residents IA Illinois: 1,099,728 units · 8,763 per 100k residents IL Indiana: 2,342,839 units · 34,142 per 100k residents IN Ohio: 4,678,930 units · 39,702 per 100k residents OH Pennsylvania: 1,508,456 units · 11,638 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 561,373 units · 8,018 per 100k residents MA California: 3,216,984 units · 8,256 per 100k residents CA Utah: 310 units · 9.1 per 100k residents UT Colorado: 1,588,242 units · 27,020 per 100k residents CO Nebraska: 315,640 units · 15,958 per 100k residents NE Missouri: 2,289,061 units · 36,944 per 100k residents MO Kentucky: 4,811,519 units · 106,308 per 100k residents KY West Virginia: 779,514 units · 44,040 per 100k residents WV Virginia: 1,230,685 units · 14,120 per 100k residents VA Maryland: no data reported MD Connecticut: 61,090 units · 1,689 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,600,184 units · 21,534 per 100k residents AZ New Mexico: 123,616 units · 5,847 per 100k residents NM Kansas: 102,000 units · 3,469 per 100k residents KS Arkansas: 1,327,600 units · 43,287 per 100k residents AR Tennessee: 487,223 units · 6,837 per 100k residents TN North Carolina: 3,633,229 units · 33,532 per 100k residents NC South Carolina: 516,240 units · 9,608 per 100k residents SC Delaware: no data reported DE Oklahoma: 768,281 units · 18,956 per 100k residents OK Louisiana: 1,141,172 units · 24,949 per 100k residents LA Mississippi: no data reported MS Alabama: 1,709,664 units · 33,470 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,325,518 units · 7,624 per 100k residents TX Florida: 4,649,774 units · 20,565 per 100k residents FL
Units reimbursed · per 100k residents
9.1133,361
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Vermont 133,361 /100k
2 Maine 109,575 /100k
3 Kentucky 106,308 /100k
4 Iowa 103,843 /100k
5 West Virginia 44,040 /100k
6 Arkansas 43,287 /100k
7 Ohio 39,702 /100k
8 Missouri 36,944 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial this page13533-0705-01 4,385 Rx · $30,754,658
1 vial13533-0705-31 No Medicaid data
1 vial13533-0705-51 No Medicaid data
Drug total (last 4 qtrs): 4,385 Rx · 56,641,532 units · $30,754,658 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by GRIFOLS USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 vial (13533-0705-31), 1 vial (13533-0705-51). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
GRIFOLS USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0256 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 13533-0703-10 · GRIFOLS 13533-0706-22 · GRIFOLS →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.