Home › NDC Lookup › Ingredients › Rabies Immune Globulin (Human) › 13533-0618-02
HYPERRAB S/D RABIES IMMUNE GLOBULIN (HUMAN) 150 [iU]/mL Injection — NDC 13533-0618-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

HYPERRAB S/D RABIES IMMUNE GLOBULIN (HUMAN) 150 [iU]/mL Injection — NDC 13533-618-02 (Billing 13533-0618-02)

by GRIFOLS USA, LLC · 1 VIAL, GLASS in 1 CARTON / 2 mL in 1 VIAL, GLASS

This is a package of HYPERRAB S/D RABIES IMMUNE GLOBULIN (HUMAN) 150 [iU]/mL Injection from GRIFOLS USA, LLC, marketed since Aug 1996 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 13533-0618-02
🏷️ FDA NDC (as labeled) 13533-618-02 billing pads the product segment with a zero
This package
Contains2 mL in 1 vial, glass Pack sizes2 compare ↓
Main listing for product 13533-618 · Also comes in: 10 mL 13533-618-10
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 13533-618-02 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
13533 labeler · 618 product · 02 package
Package marketed since
Aug 14, 1996
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1353361802 5
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 13533-618-02
Product NDC 13533-618
11-digit billing NDC 13533061802
NCPDP billing unit ML — per mL (volume)
Application # BLA101144
SPL Set ID 6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f0
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1996-08-14
Route INTRAMUSCULAR
Dosage form INJECTION
Substance HUMAN RABIES VIRUS IMMUNE GLOBULIN
Biologic (Purple Book) 351(a)

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

GPI-14 19100045002010
GPI class HyperRAB S/D
GCN Seq No 036256
GCN 43880
HICL code 035564
Ingredient (HICL) Rabies Immune Globulin/Pf
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7K
Therapeutic class — specific (HIC3) Antisera
AHFS code 80:04.00.00
AHFS class Antitoxins And Immune Globulins
FDB label name HYPERRAB S-D 150 UNITS/ML VIAL
FDB brand name Hyperrab S-D
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 036256
  • GCN: 43880
  • GPI-14 (Medi-Span): 19100045002010
  • HICL (First Databank): 035564
  • AHFS class code: 80:04.00.00
Why two NDCs? The FDA registers this code as 13533-618-02 — 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 → 13533-0618-02. 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 HYPERRAB S-D 150 UNITS/ML VIAL Ingredient Rabies Immune Globulin/Pf

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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 mL
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
13533-0618-02 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 2 mL in 1 VIAL, GLASS 1996-08-14 — Active
13533-0618-10 13533-618-10 1 VIAL in 1 CARTON / 10 mL in 1 VIAL 1996-08-14 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial, glass in 1 carton / 2 ml in 1 vial, glass.
What NDC number is used to bill for this package of HYPERRAB S/D RABIES IMMUNE GLOBULIN (HUMAN) 150 [iU]/mL Injection?
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
Hyperrab S/D 150 [iU]/mLthis 13533-0618-02 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

🏛️
1974
First FDA approval
Jun 1974
📍
2026
Currently FDA-listed
52 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
Bayrab, HyperrabRabies Immune Globulin (Human) Bayrab,HyperrabRabies Immune Globulin (Human) ImogamRabies Immune Globulin (Human) KedrabRabies Immune Globulin (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.

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 TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • 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.

2 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 applicationBLA101144 (BLA)
Labeler code13533
First marketedAug 1996
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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~3 min read ▾

INDICATIONS AND USAGE Rabies vaccine and Hyper RAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. Hyper RAB S/D should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S.

Public Health Service Advisory Committee on Immunization Practices (ACIP). (19) Every exposure to possible rabies infection must be individually evaluated. The following factors should be considered before specific antirabies treatment is initiated: 1.

Species of Biting Animal Carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies in the United States since 1960. (20) Unless the animal is tested and shown not to be rabid, postexposure prophylaxis should be initiated upon bite or nonbite exposure to these animals (see item 3 below). If treatment has been initiated and subsequent testing in a competent laboratory shows the exposing animal is not rabid, treatment can be discontinued.

In the United States, the likelihood that a domestic dog or cat is infected with rabies varies from region to region; hence, the need for postexposure prophylaxis also varies. However, in most of Asia and all of Africa and Latin America, the dog remains the major source of human exposure; exposures to dogs in such countries represent a special threat. Travelers to those countries should be aware that >50% of the rabies cases among humans in the United States result from exposure to dogs outside the United States.

Rodents (such as squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, and mice) and lagomorphs (including rabbits and hares) are rarely found to be infected with rabies and have not been known to cause human rabies in the United States. However, from 1971 through 1988, woodchucks accounted for 70% of the 179 cases of rabies among rodents reported to CDC. (21) In these cases, the state or local health department should be consulted before a decision is made to initiate post exposure antirabies prophylaxis.

2. Circumstances of Biting Incident An unprovoked attack is more likely to mean that the animal is rabid. (Bites during attempts to feed or handle an apparently healthy animal may generally be regarded as provoked.) 3.

Type of Exposure Rabies is transmitted only when the virus is introduced into open cuts or wounds in skin or mucous membranes. If there has been no exposure (as described in this section), postexposure treatment is not necessary. Thus, the likelihood that rabies infection will result from exposure to a rabid animal varies with the nature and extent of the exposure.

Two categories of exposure should be considered: Bite: any penetration of the skin by teeth. Bites to the face and hands carry the highest risk, but the site of the bite should not influence the decision to begin treatment. (22) Bat-associated strains of rabies can be transmitted to humans either directly through a bat's bite or indirectly through the bite of an animal previously infected by a bat.

Because some bat bites may be less severe, and can go completely undetected, unlike bites inflicted by larger animals, especially mammalian carnivores, rabies postexposure treatment should be considered for any physical contact with bats when bite or mucous membrane contact cannot be excluded. (23) Nonbite: scratches, abrasions, open wounds or mucous membranes contaminated with saliva or any potentially infectious material, such as brain tissue, from a rabid animal constitute nonbite exposures. If the material containing the virus is dry… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION The recommended dose for Hyper RAB S/D is 20 IU/kg (0.133 mL/kg) of body weight given preferably at the time of the first vaccine dose. (8,9) It may also be given through the seventh day after the first dose of vaccine is given. If anatomically feasible, up to the full dose of Hyper RAB S/D should be thoroughly infiltrated in the area around the wound and the rest should be administered intramuscularly in the deltoid muscle of the upper arm or lateral thigh muscle.

The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve. (26) Hyper RAB S/D should never be administered in the same syringe or needle or in the same anatomical site as vaccine. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Rabies postexposure prophylaxis schedule—United States, 1999 19 Vaccination status Treatment Regimen These regimens are applicable for all age groups, including children. HDCV=human diploid cell vaccine; PCEC=purified chick embryo cell vaccine; RIG=rabies immune globulin; RVA=rabies vaccine adsorbed; IM, intramuscular Not previously vaccinated Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water. If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds.

RIG Administer 20 IU/kg body weight. If anatomically feasible, the full dose should be infiltrated around the wound(s) and any remaining volume should be administered IM at an anatomical site distant from vaccine administration. Also, RIG should not be administered in the same syringe as vaccine.

Because RIG might partially suppress active production of antibody, no more than the recommended dose should be given. Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area The deltoid area is the only acceptable site of vaccination for adults and older children. For younger children, the outer aspect of the thigh may be used.

Vaccine should never be administered in the gluteal area. ), one each on days 0 Day 0 is the day the first dose of vaccine is administered. , 3, 7, 14, and 28. Previously vaccinated Any person with a history of preexposure vaccination with HDCV, RVA, or PCEC; prior postexposure prophylaxis with HDCV, RVA, or PCEC; or previous vaccination with any other type of rabies vaccine and a documented history of antibody response to the prior vaccination. Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water.

If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds. RIG RIG should not be administered. Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area ), one each on days 0 and 3.

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings ~1 min read ▾

WARNINGS Rabies Immune Globulin (Human) — HyperRAB TM S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (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. [1-800-520-2807]. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient. Hyper RAB S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

The attending physician who wishes to administer Hyper RAB S/D to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA. (25) As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

🤒 Adverse Reactions 56 words ▾

ADVERSE REACTIONS Soreness at the site of injection and mild temperature elevations may be observed at times. Sensitization to repeated injections has occurred occasionally in immunoglobulin-deficient patients. Angioneurotic edema, skin rash, nephrotic syndrome, and anaphylactic shock have rarely been reported after intramuscular injection, so that a causal relationship between immunoglobulin and these reactions is not clear.

🔄 Drug Interactions 73 words ▾

Drug Interactions Repeated doses of Hyper RAB S/D should not be administered once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine. Other antibodies in the Hyper RAB S/D preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after Hyper RAB S/D administration.

🤰 Pregnancy 52 words ▾

Pregnancy Category C Animal reproduction studies have not been conducted with Hyper RAB S/D. It is also not known whether Hyper RAB S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyper RAB S/D should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 13 words ▾

Pediatric Use Safety and effectiveness in the pediatric population have not been established.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY The usefulness of prophylactic rabies antibody in preventing rabies in humans when administered immediately after exposure was dramatically demonstrated in a group of persons bitten by a rabid wolf in Iran. (1,2) Similarly, beneficial results were later reported from the U.S.S.R. (3) Studies coordinated by WHO (World Health Organization) helped determine the optimal conditions under which antirabies serum of equine origin and rabies vaccine can be used in man.

(4-7) These studies showed that serum can interfere to a variable extent with the active immunity induced by the vaccine, but could be minimized by booster doses of vaccine after the end of the usual dosage series. Preparation of rabies immune globulin of human origin with adequate potency was reported by Cabasso et al. (8) In carefully controlled clinical studies, this globulin was used in conjunction with rabies vaccine of duck-embryo origin (DEV).

(8,9) These studies determined that a human globulin dose of 20 IU/kg of rabies antibody, given simultaneously with the first DEV dose, resulted in amply detectable levels of passive rabies antibody 24 hours after injection in all recipients. The injections produced minimal, if any, interference with the subject's endogenous antibody response to DEV. More recently, human diploid cell rabies vaccines (HDCV) prepared from tissue culture fluids containing rabies virus have received substantial clinical evaluation in Europe and the United States.

(10-16) In a study in adult volunteers, the administration of Rabies Immune Globulin (Human) did not interfere with antibody formation induced by HDCV when given in a dose of 20 IU per kilogram body weight simultaneously with the first dose of vaccine. (15) In a clinical study in eight healthy human adults receiving a 20 IU/kg intramuscular dose of Rabies Immune Globulin (Human) treated with solvent/detergent, Hyper RAB S/D, detectable passive rabies antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period.

These results are consistent with prior studies (17,18) with non-solvent/detergent treated product.

📦 How Supplied / Storage and Handling 84 words ▾

HOW SUPPLIED Hyper RAB S/D is packaged in 2 mL and 10 mL single dose vials with an average potency value of 150 international units per mL (IU/mL). The 2 mL vial contains a total of 300 IU which is sufficient for a child weighing 15 kg. The 10 mL vial contains a total of 1500 IU which is sufficient for an adult weighing 75 kg. Hyper RAB S/D is preservative-free and latex-free. NDC Number Size 13533-618-02 2 mL vial 13533-618-10 10 mL vial

📦 Storage and Handling 20 words ▾

STORAGE Hyper RAB S/D should be stored under refrigeration (2–8°C, 36–46°F). Solution that has been frozen should not be used.

📋 Description ~2 min read ▾

DESCRIPTION Rabies Immune Globulin (Human) — Hyper RAB TM S/D treated with solvent/detergent is a sterile solution of antirabies immune globulin for intramuscular administration; it is preservative-free and latex-free. Hyper RAB S/D is prepared by cold ethanol fractionation from the plasma of donors hyperimmunized with rabies vaccine. The immune globulin is isolated from solubilized Cohn Fraction II.

The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration.

Hyper RAB S/D is formulated as a 15 –18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. Hyper RAB S/D is then incubated in the final container for 21–28 days at 20–27°C. The product is standardized against the U.S.

Standard Rabies Immune Globulin to contain an average potency value of 150 IU/mL. The U.S. unit of potency is equivalent to the international unit (IU) for rabies antibody. The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for Hyper RAB S/D has been validated in laboratory studies.

Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III.

Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate. Additionally, 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. (27-30) Studies of the Hyper RAB S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log 10 ).

These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

⚠️ Precautions 173 words ▾

PRECAUTIONS General Hyper RAB S/D should not be administered intravenously because of the potential for serious reactions. Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactoid symptoms. Drug Interactions Repeated doses of Hyper RAB S/D should not be administered once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine.

Other antibodies in the Hyper RAB S/D preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after Hyper RAB S/D administration. Pregnancy Category C Animal reproduction studies have not been conducted with Hyper RAB S/D.

It is also not known whether Hyper RAB S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyper RAB S/D should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness in the pediatric population have not been established.

📚 References ~3 min read ▾

REFERENCES Baltazard M, Bahmanyar M, Ghodssi M, et al: Essai pratique du sérum antirabique chez les mordus par loups enragés. Bull WHO 13:747-72, 1955. Habel K, Koprowski H: Laboratory data supporting the clinical trial of antirabies serum in persons bitten by a rabid wolf.

Bull WHO 13:773-9, 1955. Selimov M, Boltucij L, Semenova E, et al: [The use of antirabies gamma globulin in subjects severely bitten by rabid wolves or other animals.] J Hyg Epidemiol Microbiol Immunol (Praha) 3. 168-80, 1959.

Atanasiu P, Bahmanyar M, Baltazard M, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine inoculations in non-exposed persons. Bull WHO 14:593-611, 1956. Atanasiu P, Bahmanyar M, Baltazard M, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine inoculations in non-exposed persons: Part II.

Bull WHO 17:911-32, 1957. Atanasiu P, Cannon DA, Dean DJ, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine innoculations in non-exposed persons: Part 3. Bull WHO 25:103-14, 1961.

Atanasiu P, Dean DJ, Habel K, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine inoculations in non-exposed persons: Part 4. Bull WHO 36:361-5, 1967. Cabasso VJ, Loofbourow JC, Roby RE, et al: Rabies immune globulin of human origin: preparation and dosage determination in non-exposed volunteer subjects.

Bull WHO 45:303-15, 1971. Loofbourow JC, Cabasso VJ, Roby RE, et al: Rabies immune globulin (human): clinical trials and dose determination. JAMA 217(13): 1825-31, 1971.

Plotkin SA: New rabies vaccine halts disease — without severe reactions. Mod Med 45(20):45-8, 1977. Plotkin SA, Wiktor TJ, Koprowski H, et al: Immunization schedules for the new human diploid cell vaccine against rabies.

Am J Epidemiol 103(1):75-80, 1976. Hafkin B, Hattwick MA, Smith JS, et al: A comparison of a WI-38 vaccine and duck embryo vaccine for preexposure rabies prophylaxis. Am J Epidemiol 107(5):439-43, 1978.

Kuwert EK, Marcus I, Höher PG: Neutralizing and complement-fixing antibody responses in pre- and post-exposure vaccinees to a rabies vaccine produced in human diploid cells. J Biol Stand 4(4):249-62, 1976. Grandien M: Evaluation of tests for rabies antibody and analysis of serum responses after administration of three different types of rabies vaccines.

J Clin Microbiol 5(3):263-7, 1977. Kuwert EK, Marcus I, Werner J, et al: Postexpositionelle Schutzimpfung des Menschen gegen Tollwut mit einer neu-entwickelten Gewebekulturvakzine (HDCS-Impfstoff). Zentralbl Bakteriol [A] 239(4):437-58, 1977.

Bahmanyar M, Fayaz A, Nour-Salehi S, et al: Successful protection of humans exposed to rabies infection: postexposure treatment with the new human diploid cell rabies vaccine and antirabies serum. JAMA 236(24):2751-4, 1976. American Hospital Formulary Service.

Drug Information. Section 80:04. Rabies immune globulin.

Bethesda, American Society for Health-Systems Pharmacy, 1997, p. 2545-7. Rubin Rh, Sikes RK, Gregg MB: Human rabies immune globulin.

Clinical trials and effects on serum anti-globulins. JAMA 224:871-4, 1973. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Rabies prevention—United States, 1999.

MMWR 48 (RR-1):1-21, 1999. Reid-Sanden FL, Dobbins JG, Smith JS, et al: Rabies surveillance in the United States during 1989. J Am Vet Med Assoc 197(12):1571-83, 1990.

Fishbein DB, Belotto AJ, Pacer RE, et al: Rabies in rodents and lagomorphs in the United States, 1971-1984: increased cases in the woodchuck ( Marmota monax ) in mid-Atlantic states. J Wildl Dis 22(2):151-5, 1986. Hattwick MAW: Human rabies.

Public Health Rev 3(3):229-74, 1974. Epidemiologic Notes and Reports: Human Rabies—California, 1994. MMWR 43(25):455-457, 1994.

Garner JS, Simmons BP: Guideline for isolation precautions in hospitals. Infect Control 4(4 Suppl):245-325, 1983. Fudenberg HH: Sensitization to immunoglobulins and hazards of gamma globulin therapy.… [Excerpted — this section continues on DailyMed.]

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

PACKAGE LABEL Rabies Immune Globulin (Human) Hyper RAB™ S/D Solvent/Detergent Treated Preservative-free, latex-free 150 IU/mL Suitable for use with Rabies Vaccine 10 mL NDC 13533-618-10 Talecris BIOTHERAPEUTICS The patient and physician should discuss the risks and benefits of this product. One Single Dose Vial FOR INTRAMUSCULAR INJECTION ONLY. DO NOT GIVE INTRAVENOUSLY.

For complete dosage and administration information, read enclosed package insert. Store at 2-8°C (36-46°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 dispensing without prescription.

Rabies Immune Globulin (Human) is a sterile solution of immunoglobulin containing 15%-18% protein stabilized with 0.21-0.32 M glycine. The pH is adjusted with sodium carbonate. The potency of each vial is 150 IU/mL based on the U.S.

Standard Rabies Immune Globulin. 08940040 Talecris Biotherapeutics, Inc. Research Triangle Park, NC 27709 USA U.S.

License No. 1716 LOT EXP. NDC 13533-618-10 Rabies Immune Globulin (Human) Hyper RAB™ S/D 10 mL Solvent/Detergent Treated Talecris The Patient and Biotherapeutics, Inc . physician should RTP, NC 27709 discuss the risks and U.S.

License No. 1716 benefits of this product. 08907466 Lot Exp.

One Single Dose Vial 150 IU/mL Do not give intravenously. Dosage: 20 IU/kg in con- junction with Rabies Vaccine. See directions before using.

Rx only

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

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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 1 other package presentation of this same product, including 1 vial (13533-0618-10). 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.
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.
← 13533-0613-20 · GRIFOLS 13533-0631-02 · 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.