Home › NDC Lookup › Ingredients › Antithrombin Iii (Human) › 13533-0602-50
Thrombate Iii Antithrombin Iii (HUMAN) Kit — NDC 13533-0602-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Thrombate Iii Antithrombin Iii (HUMAN) Kit — NDC 13533-602-50 (Billing 13533-0602-50)

by GRIFOLS USA, LLC · 1 KIT in 1 CARTON * 10 mL in 1 VIAL, GLASS * 10 mL in 1 VIAL, GLASS

This is a package of Thrombate Iii Antithrombin Iii (HUMAN) Kit from GRIFOLS USA, LLC, marketed since Dec 1991 and currently FDA-listed. It is this product's only package size.

NDC 13533-0602-50
🏷️ FDA NDC (as labeled) 13533-602-50 billing pads the product segment with a zero
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 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 13533-602-50 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
13533 labeler · 602 product · 50 package
Package marketed since
Dec 30, 1991
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1353360250 5
Medicaid fills, this package
76 prescriptions in the last four reported quarters
FDA record last changed
Oct 2, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 13533-602-50
Product NDC 13533-602
11-digit billing NDC 13533060250
NCPDP billing unit EA — each (per item)
Application # BLA103196
SPL Set ID b2a9f856-3ef7-8da4-920c-f738e4f1f7d7
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1991-12-30
Dosage form KIT
Biologic (Purple Book) 351(a)

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

GPI-14 85400015102110
GPI class Thrombate III
GCN Seq No 046294
GCN 13660
HICL code 005735
Ingredient (HICL) Antithrombin Iii (Plasma Der)
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M0
Therapeutic class — intermediate (HIC2) Blood And Blood Replacement Preparations
HIC3 code M0B
Therapeutic class — specific (HIC3) Plasma Proteins
AHFS code 20:12.04.20
AHFS class Antithrombin Replacements
FDB label name THROMBATE III 500 UNIT VIAL
FDB brand name Thrombate Iii
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 046294
  • GCN: 13660
  • GPI-14 (Medi-Span): 85400015102110
  • HICL (First Databank): 005735
  • AHFS class code: 20:12.04.20
Why two NDCs? The FDA registers this code as 13533-602-50 — 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 → 13533-0602-50. 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 THROMBATE III 500 UNIT VIAL Ingredient Antithrombin Iii (Plasma Der)

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $4.09 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7197 $4.174 / J7197 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)13533-602-50
11-digit billing NDC13533-0602-50
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7197
DescriptorAntithrombin iii (human), per i.u.
Billing units / pkg1 units
How the units are derivedThis package is 1; the HCPCS unit is 1 IU, so one package = 1 billing unit.
Medicare Part B spend (2025 (Q1-Q4))$88,502 · 11 claims · $8,045.66 per claim (all NDCs under J7197)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
13533-0602-50 You're viewing this Main listing 1 KIT in 1 CARTON * 10 mL in 1 VIAL, GLASS * 10 mL in 1 VIAL, GLASS 1991-12-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Thrombate Iiithis 13533-0602-50 GRIFOLS 1 kit — — FDA listed —
Thrombate Iii 13533-0603-20 GRIFOLS 1 kit — — FDA listed —
Thrombate Iii 13533-0606-12 GRIFOLS 1 kit — — 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

🏛️
1991
First FDA approval
Dec 1991
📍
2026
Currently FDA-listed
35 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.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Thrombate IiiAntithrombin III (Human)
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 applicationBLA103196 (BLA)
Labeler code13533
First marketedDec 1991
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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 218 words ▾

INDICATIONS AND USAGE SECTION THROMBATE III is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. Subjects with AT-­III deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease. The diagnosis of hereditary antithrombin III (AT-­III) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma AT-­III levels, and the exclusion of acquired deficiency.

AT-­III in plasma may be measured by amidolytic assays using synthetic chromogenic substrates, by clotting assays, or by immunoassays. The latter does not detect all hereditary AT-­III deficiencies. 16 The AT­-III level in neonates of parents with hereditary AT-­III deficiency should be measured immediately after birth.

(Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) 17 Plasma levels of AT-­III are lower in neonates than adults, averaging approximately 60% in normal term infants. 18,19 AT­-III levels in premature infants may be much lower. 18,19 Low plasma AT-­III levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency.

It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. 11

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Each bottle of THROMBATE III has the functional activity, in international units (IU), stated on the label of the bottle. The potency assignment has been determined with a standard calibrated against a World Health Organization antithrombin III reference preparation. Dosage should be determined on an individual basis based on the pre­therapy plasma antithrombin III (AT-­III) level, in order to increase plasma AT­-III levels to the level found in normal human plasma (100%).

Dosage of THROMBATE III can be calculated from the following formula: [desired-­baseline AT-­III level*] X weight (kg) units required (IU) = _________________________________________ 1.4 *expressed as % normal level based on functional AT-­III assay The above formula is based on an expected incremental in vivo recovery above baseline levels for Antithrombin III (Human), THROMBATE III ® of 1.4% per IU per kg administered. 12 Thus, if a 70 kg individual has a baseline AT–III level of 57%, in order to increase plasma AT-­III to 120%, the initial THROMBATE III dose would be [(120–57) X70]/1.4 = 3150 IU total.

However, recovery may vary, and initially levels should be drawn at baseline and 20 minutes postinfusion. Subsequent doses can be calculated based on the recovery of the first dose. These recommendations are intended only as a guide for therapy.

The exact loading dose and maintenance intervals should be individualized for each patient. It is recommended that following an initial dose of THROMBATE III, plasma levels of AT­-III be initially monitored at least every 12 hours and before the next infusion of THROMBATE III to maintain plasma AT-­III levels greater than 80%. In some situations, e.g., following surgery, 20 hemorrhage or acute thrombosis, and during intravenous heparin administration, 13,21–23 the half-­life of Antithrombin III (Human) has been reported to be shortened.

In such conditions, plasma AT-­III levels should be monitored more frequently, and THROMBATE III administered as necessary. When an infusion of THROMBATE III is indicated for a patient with hereditary deficiency to control an acute thrombotic episode or prevent thrombosis following surgical or obstetrical procedures, it is desirable to raise the AT­-III level to normal and maintain this level for 2 to 8 days, depending on the indication for treatment, type and extent of surgery, patient’s medical condition, past history and physician’s judgment.

Concomitant administration of heparin in each of these situations should be based on the medical judgment of the physician. As a general recommendation, the following therapeutic program may be utilized as a starting program for treatment, modifying the program based on the actual plasma AT­-III levels achieved: a)An initial loading dose of THROMBATE III calculated to elevate the plasma AT-­III level to 120%, assuming an expected rise over the baseline plasma AT­-III level of 1.4% (functional activity) per IU per kg of THROMBATE III administered.

Thus, if an individual has a baseline AT­-III level of 57%, the initial THROMBATE III dose would be (120–57)/1.4 = 45 IU/kg. b)Measure preinfusion and 20 minutes postinfusion (peak) plasma antithrombin III levels following the initial loading dose, plasma antithrombin III level after 12 hours, then preceding the next infusion (trough level). Subsequently measure antithrombin III levels preceding and 20 minutes after each infusion until predictable peak and trough levels have been achieved, generally between 80%–120%.

Plasma levels between 80%–120% may be maintained by administration of maintenance doses of 60% of the initial loading dose, administered every 24 hours. Adjustments in the maintenance dose and/or interval between doses should be made based on actual plasma AT-­III levels achieved. The above recommendations for dosing are provided as a general guideline for therapy only.

The exact loading and maintenance dosages and dosing intervals should be individualized for eac… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 204 words ▾

WARNINGS SECTION THROMBATE III is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically, the Creutzfeldt­-Jakob (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.

Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.

ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. [1800­-520-­2807] The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to a patient. The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary AT-­III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III.

🤒 Adverse Reactions 90 words ▾

ADVERSE REACTIONS In clinical studies involving THROMBATE III, adverse reactions were reported in association with 17 of the 340 infusions during the clinical studies. Included were dizziness (7), chest tightness (3), nausea (3), foul taste in mouth (3), chills (2), cramps (2), shortness of breath (1), chest pain (1), film over eye (1), light­-headedness (1), bowel fullness (1), hives (1), fever (1), and oozing and hematoma formation (1). If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Antithrombin III (AT-­III), an alpha 2­ -glycoprotein of molecular weight 58,000, is normally present in human plasma at a concentration of approximately 12.5 mg/dL 2,3 and is the major plasma inhibitor of thrombin. 4 Inactivation of thrombin by AT-­III occurs by formation of a covalent bond resulting in an inactive 1:1 stoichiometric complex between the two, involving an interaction of the active serine of thrombin and an arginine reactive site on AT-­III. 4 AT-­III is also capable of inactivating other components of the coagulation cascade including factors IXa, Xa, XIa, and XIIa, as well as plasmin.

4 The neutralization rate of serine proteases by AT­-III proceeds slowly in the absence of heparin, but is greatly accelerated in the presence of heparin. 4 As the therapeutic antithrombotic effect in vivo of heparin is mediated by AT­-III, heparin is ineffective in the absence or near absence of AT­-III. 4–8 The prevalence of the hereditary deficiency of AT­-III is estimated to be one per 2000 to 5000 in the general population.

4–7 The pattern of inheritance is autosomal dominant. In affected individuals, spontaneous episodes of thrombosis and pulmonary embolism may be associated with AT-­III levels of 40%–60% of normal. 7 These episodes usually appear after the age of 20, the risk increasing with age and in association with surgery, pregnancy and delivery.

The frequency of thromboembolic events in hereditary antithrombin III (AT-­III) deficiency during pregnancy has been reported to be 70%, and several studies of the beneficial use of Antithrombin III (Human) concentrates during pregnancy in women with hereditary deficiency have been reported. 9–11 In many cases, however, no precipitating factor can be identified for venous thrombosis or pulmonary embolism. 7 Greater than 85% of individuals with hereditary AT-­III deficiency have had at least one thrombotic episode by the age of 50 years.

7 In about 60% of patients thrombosis is recurrent. Clinical signs of pulmonary embolism occur in 40% of affected individuals. 7 In some individuals, treatment with oral anticoagulants leads to an increase of the endogenous levels of AT-­III, and treatment with oral anticoagulants may be effective in the prevention of thrombosis in such individuals.

6,7 In clinical studies of THROMBATE III conducted in 10 asymptomatic subjects with hereditary deficiency of AT-­III, the mean in vivo recovery of AT-­III was 1.6% per unit per kg administered based on immunologic AT-­III assays, and 1.4% per unit per kg administered based on functional AT-­III assays. 12 The mean 50% disappearance time (the time to fall to 50% of the peak plasma level following an initial administration) was approximately 22 hours and the biologic half­-life was 2.5 days based on immunologic assays and 3.8 days based on functional assays of AT-­III.

12 These values are similar to the half­life for radiolabeled Antithrombin III (Human) reported in the literature of 2.8–4.8 days. 13–1 5 In clinical studies of THROMBATE III, none of the 13 patients with hereditary AT­-III deficiency and histories of thromboembolism treated prophylactically on 16 separate occasions with THROMBATE III for high thrombotic risk situations (11 surgical procedures, 5 deliveries) developed a thrombotic complication. Heparin was also administered in 3 of the 11 surgical procedures and all 5 deliveries.

Eight patients with hereditary AT-­III deficiency were treated therapeutically with THROMBATE III as well as heparin for major thrombotic or thromboembolic complications, with seven patients recovering. Treatment with THROMBATE III reversed heparin resistance in two patients with hereditary AT-­III deficiency being treated for thrombosis or thromboembolism. During clinical investigation of THROMBATE III, none of 12 subjects monitored for a median of 8 months (range 2–19 months) after receiving THROMBATE III, became antibody positive to human immunodeficiency virus (HIV­-1).

None of 14 subjects moni… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 58 words ▾

HOW SUPPLIED THROMBATE III is supplied in the following single use vials with the potency in international units stated on the label of each vial. A suitable volume of Sterile Water for Injection, USP, a sterile double­ended transfer needle, and a sterile filter needle are provided. NDC Number Approximate Antithrombin III Potency Diluent 13533-603-20 500 IU 10 mL

📦 Storage and Handling 25 words ▾

STORAGE THROMBATE III should be stored at temperatures not to exceed 25°C (77°F). Freezing should be avoided as breakage of the diluent bottle might occur.

📋 Description ~1 min read ▾

DESCRIPTION Antithrombin III (Human), THROMBATE III ® is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III. THROMBATE III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold ethanol method of Cohn. 1 When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0–7.5, a sodium content of 110–210 mEq/L, a chloride content of 110–210 mEq/L, an alanine content of 0.075–0.125 M, and a heparin content of not more than

0.1IU heparin/IU AT­-III. THROMBATE III contains no preservative and must be administered by the intravenous route. In addition, THROMBATE III has been heat­-treated in solution at 60°C ±0.5°C for not less than 10 hours.

Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization (WHO) antithrombin III reference preparation. The manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.

24­-27 An individual production step in the THROMBATE III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 logs). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

Thrombate Use Figures

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution. Administer only by the intravenous route.

THROMBATE III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions. Product administration and handling of the needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious virus including HIV (AIDS) and hepatitis.

Obtain immediate medical attention if injury occurs. Place needles in sharps container after single use. Discard all equipment including any reconstituted THROMBATE III product in accordance with biohazard procedures.

The diagnosis of hereditary antithrombin III (AT-­III) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma AT-­III levels, and the exclusion of acquired deficiency. Laboratory Tests It is recommended that AT-­III plasma levels be monitored during the treatment period. Functional levels of AT­-III in plasma may be measured by amidolytic assays using chromogenic substrates or by clotting assays.

Drug Interactions The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary AT­-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to THROMBATE III.

It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pediatri c Us e Safety and effectiveness in the pediatric population have not been established.

The AT­-III level in neonates of parents with hereditary AT-­III deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) 17 Plasma levels of AT-­III are lower in neonates than adults, averaging approximately 60% in normal term infants. 18,19 AT-­III levels in premature infants may be much lower.

18,19 Low plasma AT-­III levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. 11

📚 References ~3 min read ▾

REFERENCES Cohn EJ, Strong LE, Hughes WL Jr, et al: Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids.

J Am Chem Soc 68(3):459-­75, 1946. Rosenberg RD, Bauer KA, Marcum JA: Antithrombin III “the heparin-­antithrombin system.” Rev Hematol 2:351­-416, 1986. Murano G, Williams L, Miller-­Andersson M: Some properties of antithrombin-­III and its concentration in human plasma.

Thromb Res 18(1­2):259­-62, 1980. Rosenberg RD: Action and interactions of antithrombin and heparin. N Engl J Med 292(3):146­-51, 1975.

Winter JH, Fenech A, Ridley W, et al: Familial antithrombin III deficiency. Q J Med 51(204):373-­95, 1982. Marciniak E, Farley CH, DeSimone PA: Familial thrombosis due to antithrombin III deficiency.

Blood 43(2):219­31, 1974. Thaler E, Lechner K: Antithrombin III deficiency and thromboembolism. Clin Haematol 10(2):369­-90, 1981.

Blauhut B, Necek S, Kramar H, et al: Activity of antithrombin III and effect of heparin on coagulation in shock. Thromb Res 19(6):775­-82, 1980. Samson D, Stirling Y, Woolf L, et al: Management of planned pregnancy in a patient with congenital antithrombin III deficiency.

Br J Haematol 56(2):243-­9, 1984. Brandt P: Observations during the treatment of antithrombin-­III deficient women with heparin and antithrombin concentrate during pregnancy, parturition, and abortion. Thromb Res 22(1­-2):15­-24, 1981.

Hellgren M, Tengborn L, Abildgaard U: Pregnancy in women with congenital antithrombin III deficiency: experience of treatment with heparin and antithrombin. Gynecol Obstet Invest 14(2):127-­41, 1982. Schwartz RS, Bauer KA, Rosenberg RD, et al: Clinical experience with antithrombin III concentrate in treatment of congenital and acquired deficiency of antithrombin.

Am J Med 87 (Suppl 3B): 53S­-60S, 1989. Collen D, Schetz J, de Cock F, et al: Metabolism of antithrombin III (heparin cofactor) in man: effects of venous thrombosis and of heparin administration. Eur J Clin Invest 7(1):27­-35, 1977.

Knot EAR, de Jong E, ten Cate JW, et al: Purified radiolabeled antithrombin III metabolism in three families with hereditary AT III deficiency: application of a three-­compartment model. Blood 67(1):93-­8, 1986. Tengborn L, Frohm B, Nilsson LE, et al: Antithrombin III concentrate: its catabolism in health and in antithrombin III deficiency.

Scand J Clin Lab Invest 41(5):469­-77, 1981. Sas G, Blasko G, Banhegyi D, et al: Abnormal antithrombin III (antithrombin III “Budapest”) as a cause of familial thrombophilia. Thromb Diath Haemorrh 32(1):105­-15, 1974.

Bjarke B, Herin P, Blomback M: Neonatal aortic thrombosis. A possible clinical manifestation of congenital antithrombin III deficiency. Acta Paediatr Scand 63:297­-301, 1974.

Hathaway WE, Bonnar J: Perinatal coagulation. New York, Grune & Stratton, 1978, p.68. Peters M, Jansen E, ten Cate JW, et al: Neonatal antithrombin III.

Br J Haematol 58(4):579­-87, 1984. Mannucci PM, Boyer C, Wolf M, et al: Treatment of congenital antithrombin III deficiency with concentrates. Br J Haematol 50(3):531­5, 1982.

Marciniak E, Gockerman JP: Heparin­induced decrease in circulating antithrombin­III. Lancet 2 (8038):581­4, 1977. O’Brien JR, Etherington MD: Effect of heparin and warfarin on antithrombin III.

Lancet 2(8050):1232, 1977. Kakkar VV, Bentley PG, Scully MF, et al: Antithrombin III and heparin. Lancet 1(8159):103­-4, 1980.

Stenland CJ, Lee DC, Brown P, et al. Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma. Transfusion 2002.

42(11):1497­-500. Lee DC, Stenland CJ, Miller JL, et al. A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins.

Transfusion 2001. 41(4):449­-55. Lee DC, Stenland CJ, Hartwell RC, et al.

Monitoring plasma processing steps with a sensit… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE LABEL NDC 13533-603-20 Antithrombin III (Human) THROMBATE III ® Heat-Treated Lyophilized In Solution Powder Talecris Biotherapeutics, Inc. Research Triangle Park, NC 27709 USA U.S. License No.

1716 The risk of transmission of hepatitis and other viral deseases is present. The patient and physician should discuss the risks and benefits of this product. No Preservative For Intravenous Administration Only Sterile - Nonpyrogenic Reconstitute with 10 mL Sterile Water for Injection, USP.

Store at temperatures not to exceed 25ºC (77º F). Do not freeze. Dosage and Administration: Read package insert.

Rx only THIS PRODUCT IS PREPARED FROM LARGE POOLS OF HUMAN PLASMA WHICH MAY CONTAIN THE CAUSATIVE AGENTS OF HEPATITIS AND OTHER VIRAL DISEASES. SEE PACKAGE INSERT WARNINGS The patient and physician should discuss the risks and benefits of this product. The product when reconstituted with 10 mL Sterile Water for injection, USP, contains 110-210 mEq/L sodium, 110-210 mEq/L chloride, 0.075-0.125 M alanine, and not more than

0.1Iu heparin/IU AT-III. Administer within 3 hours after reconstitution. Dosage and Administration: Read enclosed package insert.

Store at temperature not to exceed 25º C (77º F). Do not freeze. If the shrink band is absent or shows any sign of tampering, do not use the product and notify Talecris Biotherapeutics, Inc. immediately.

Not Returnable for Credit or Exchange Rx only CAUTION: U.S. federal law prohibits despensing without prescription CONTENTS: One bottle of THROMBATE III 10 mL Sterile Water for Injection, USP One sterile filter needle One sterile double-ended transfer needle No Preservative For Intravenous Administration Only Sterile-Nonpyrogenic

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
76
Units reimbursed last 4 qtrs
39.5K
Gross reimbursed last 4 qtrs
$161.7K
Avg / prescription
$2,127.11
Avg / unit
$4.0927
Latest quarter Q1 2026
27Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 76 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 39,500 units · 101 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
101101
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 California 101 /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.

About this NDC listing & data coverage

Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
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 J7197 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.
← 13533-0502-01 · Grifols 13533-0603-20 · 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.