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PRE-PEN benzylpenicilloyl polylysine 60 umol/.25mL Injection, 5 ampules — NDC 49471-0001-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PRE-PEN benzylpenicilloyl polylysine 60 umol/.25mL Injection, 5 ampules — NDC 49471-001-05 (Billing 49471-0001-05)

by ALK-ABELLO, INC. · 5 AMPULE in 1 CARTON / .25 mL in 1 AMPULE

This is a package of 5 ampules of PRE-PEN benzylpenicilloyl polylysine 60 umol/.25mL Injection from ALK-ABELLO, INC., marketed since Jul 1974 and currently FDA-listed. It is this product's only package size.

NDC 49471-0001-05
🏷️ FDA NDC (as labeled) 49471-001-05 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 49471-001-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
49471 labeler · 001 product · 05 package
Package marketed since
Jul 25, 1974
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 4947100105 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49471-001-05
Product NDC 49471-001
11-digit billing NDC 49471000105
NCPDP billing unit ML — per mL (volume)
UNII 76479814OY
Application # BLA050114
SPL Set ID 2fbcc40c-f102-4abe-bce5-a93de95874fe
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1974-07-25
Route INTRADERMAL, SUBCUTANEOUS
Dosage form INJECTION
Substance BENZYLPENICILLOYL POLYLYSINE
Biologic (Purple Book) 351(a)

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

GPI-14 94200020002005
GPI class Pre-Pen
GCN Seq No 009707
GCN 40550
HICL code 004233
Ingredient (HICL) Benzylpenicilloyl Polylysine
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7T
Therapeutic class — specific (HIC3) Antigenic Skin Tests
AHFS code 36:30.00.00
AHFS class Drug Hypersensitivity
FDB label name PRE-PEN AMPUL
FDB brand name Pre-Pen
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009707
  • GCN: 40550
  • GPI-14 (Medi-Span): 94200020002005
  • HICL (First Databank): 004233
  • AHFS class code: 36:30.00.00
Why two NDCs? The FDA registers this code as 49471-001-05 — 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 → 49471-0001-05. 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 PRE-PEN AMPUL Ingredient Benzylpenicilloyl Polylysine

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.
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
49471-0001-05 You're viewing this Main listing 5 AMPULE in 1 CARTON / .25 mL in 1 AMPULE 1974-07-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pre-Pen 60 umol/.25mLthis 49471-0001-05 ALK-ABELLO, 5 ampules — — 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
Jul 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
Pre-Penbenzylpenicilloyl polylysine
🔒 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.

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

  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • 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.

4 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

LabelerALK-ABELLO, INC.
FDA applicationBLA050114 (BLA)
Labeler code49471
First marketedJul 1974
Product typeHuman Prescription Drug
Portfolio411 products on file
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 prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 133 words ▾

INDICATIONS AND USAGE: PRE-PEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. A negative skin test to PRE-PEN is associated with an incidence of immediate allergic reactions of less than 5% after the administration of therapeutic penicillin, whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PRE-PEN. These allergic reactions are predominantly dermatologic.

Whether a negative skin test to PRE-PEN predicts a lower risk of anaphylaxis is not established. Similarly, when deciding the risk of proposed penicillin treatment, there are not enough data at present to permit relative weighing in individual cases of a history of clinical penicillin hypersensitivity as compared to positive skin tests to PRE-PEN and/or minor penicillin determinants.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION: SKIN TESTING DOSAGE AND TECHNIQUE Skin testing responses can be attenuated by interfering drugs (e.g. H1-antihistamines and vasopressors). Skin testing should be delayed until the effects of such drugs have dissipated, or a separate skin test with histamine can be used to evaluate persistent antihistaminic effects in vivo.

Due to the risk of potential systemic allergic reactions, skin testing should be performed in an appropriate healthcare setting under direct medical supervision. Puncture Testing : Skin testing is usually performed on the inner volar aspect of the forearm. The skin test antigen should always be applied first by the puncture technique.

After preparing the skin surface, apply a small drop of PRE-PEN solution using a sterile 22-28 gauge needle. The same needle can then be used to make a single shallow puncture of the epidermis through the drop of PRE-PEN. Very little pressure is required to break the epidermal continuity.

Observe for the appearance of a wheal, erythema, and the occurrence of itching at the test site during the succeeding 15 minutes at which time the solution over the puncture site is wiped off. A positive reaction consists of the development within 10 minutes of a pale wheal, sometimes with pseudopods, surrounding the puncture site and varying in diameter from 5 to 15 mm (or more). This wheal may be surrounded by a variable diameter of erythema, and accompanied by a variable degree of itching.

The most sensitive individuals develop itching quickly, and the wheal and erythema are prompt in their appearance. As soon as a positive response as defined above is clearly evident, the solution over the scratch should be immediately wiped off. If the puncture test is either negative or equivocally positive (less than 5 mm wheal with little or no erythema and no itching), an intradermal test may be performed.

The lntradermal Test : Using a 0.5 to 1.0 cc syringe with a 3/8” to 5/8”long, 26 to 30 gauge, short bevel needle, withdraw the contents of the ampule. Prepare with an alcohol swab a skin test area on the upper, outer arm, sufficiently below the deltoid muscle to permit proximal application of a tourniquet later, if necessary. Be sure to eject all air from the syringe through the needle, then insert the needle, bevel up immediately below the skin surface.

Inject an amount of PRE-PEN sufficient to raise a small intradermal bleb of about 3 mm in diameter, in duplicate at least 2 cm apart. Using a separate syringe and needle, inject a like amount of saline or allergen diluting solution as a control at least 5 cm removed from the antigen test sites. Most skin reactions will develop within 5-15 minutes and response to the skin test is read at 20 minutes as follows: Negative response — no increase in size of original bleb and no greater reaction than the control site.

Ambiguous response — wheal only slightly larger than initial injection bleb, with or without accompanying erythematous flare and slightly larger than the control site; OR discordance between duplicates. Positive response — itching and significant increase in size of original blebs to at least 5 mm. Wheal may exceed 20 mm in diameter and exhibit pseudopods.

If the control site exhibits a wheal greater than 2-3 mm, repeat the test, and if the same reaction is observed, a physician experienced with allergy skin testing should be consulted.

⛔ Contraindications 34 words ▾

CONTRAINDICATIONS: PRE-PEN is contraindicated in those patients who have exhibited either a systemic or marked local reaction to its previous administration. Patients known to be extremely hypersensitive to penicillin should not be skin tested.

⚠️ Warnings 60 words ▾

WARNINGS: The risk of sensitization to repeated skin testing with PRE-PEN is not established. Rarely, a systemic allergic reaction including anaphylaxis (see below) may follow a skin test with PRE-PEN. To decrease the risk of a systemic allergic reaction, puncture skin testing should be performed first. Intradermal skin testing should be performed only if the puncture test is entirely negative.

🤒 Adverse Reactions 75 words ▾

ADVERSE REACTIONS: Occasionally, patients may develop an intense local inflammatory response at the skin test site. Rarely, patients will develop a systemic allergic reaction, manifested by generalized erythema, pruritus, angioedema, urticaria, dyspnea, hypotension, and anaphylaxis. The usual methods of treating a skin test antigen-induced reaction — the applications of a venous occlusion tourniquet proximal to the skin test site and administration of epinephrine are recommended.

The patient should be kept under observation for several hours.

🤰 Pregnancy 51 words ▾

Pregnancy: Animal reproduction studies have not been conducted with PRE-PEN. It is not known whether PRE-PEN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The hazards of skin testing in such patients should be weighed against the hazard of penicillin therapy without skin testing.

🧬 Clinical Pharmacology 193 words ▾

CLINICAL PHARMACOLOGY: PRE-PEN is a skin test antigen reagent that reacts specifically with benzylpenicilloyl IgE antibodies initiating the release of chemical mediators which produce an immediate wheal and flare reaction at a skin test site. All individuals exhibiting a positive skin test to PRE-PEN possess IgE against the benzylpenicilloyl structural group which is a hapten. A hapten is a low molecular weight chemical that conjugates with a carrier (e.g. poly-l-lysine) resulting in the formation of an antigen with the hapten’s specificity.

The benzylpenicilloyl hapten is the major antigenic determinant in penicillin-allergic individuals. However, many individuals reacting positively to PRE-PEN will not develop a systemic allergic reaction on subsequent exposure to therapeutic penicillin, especially among those who have not reacted to penicillins in the past. Thus, the PRE-PEN skin test determines the presence of penicilloyl IgE antibodies which are necessary but not sufficient for acute allergic reactions due to the major penicilloyl determinant.

Non-benzylpenicilloyl haptens are designated as minor determinants, since they less frequently elicit an immune response in penicillin treated individuals. The minor determinants may nevertheless be associated with significant clinical hypersensitivity. PRE-PEN does not react with IgE antibodies directed against non-benzylpenicilloyl haptens.

📦 How Supplied / Storage and Handling 176 words ▾

HOW SUPPLIED: NDC 49471-001-05 PRE-PEN ® (benzylpenicilloyl polylysine) injection is a clear, colorless, sterile solution in a concentration of

6.0X 10 -5 M (benzylpenicilloyl) supplied in ampules containing 0.25 mL. Box of 5 single-dose ampules. Ampules are opened by snapping the neck of the ampule using two forefingers of each hand.

Visually inspect for glass shards before use. Each ampule is for single patient use only. Discard any unused portion.

Store PRE-PEN refrigerated at 2°C to 8°C (36°F to 46°F). If removed from refrigerator, PRE-PEN should be kept at room temperature up to 25°C (77°F) and must be used within 24 hours. Discard any unused portion.

As with all parenteral drug products, PRE-PEN should be inspected visually for particulate matter and discoloration prior to administration. Report presence of particulate matter or discoloration to Manufacturer. Rx only Manufactured by AllerQuest LLC 10 Farmington Valley Drive, Suite 106, Plainville, CT 06062 US License No.

2265 Distributed by ALK-Abelló, Inc. 35 Channel Drive, Port Washington, NY 11050 Printed in USA PRPE399999 12/2022 ©2022 ALK-Abelló, Inc. and AllerQuest LLC

📋 Description 70 words ▾

DESCRIPTION: PRE-PEN ® (benzylpenicilloyl polylysine) injection is a sterile solution of benzylpenicilloyl polylysine in a concentration of

6.0 X 10 -5 M (benzylpenicilloyl) in

0.01 M monobasic sodium phosphate and

0.15M sodium chloride. Benzylpenicilloyl polylysine is a derivative of poly-l-lysine, where the epsilon amino groups are substituted with benzylpenicilloyl groups (50-70%) forming benzylpenicilloyl alpha amide. Each single-dose ampule contains 0.25 mL of PRE-PEN. PRE-PEN has the following structure: Structure

⚠️ Precautions ~1 min read ▾

PRECAUTIONS: General: No reagent, test, or combination of tests will completely assure that a reaction to penicillin therapy will not occur. The value of the PRE-PEN skin test alone as a means of assessing the risk of administering therapeutic penicillin (when penicillin is the preferred drug of choice) in the following situations is not established: 1. Adult patients who give no history of clinical penicillin hypersensitivity.

2. Pediatric patients. In addition, the clinical value of PRE-PEN where exposure to penicillin is suspected as a cause of a current drug reaction or in patients who are undergoing routine allergy evaluation is not known.

Likewise, the clinical value of PRE-PEN skin tests alone in determining the risk of administering semi-synthetic penicillins (phenoxymethyl penicillin, ampicillin, carbenicillin, dicloxacillin, methicillin, nafcillin, oxacillin, amoxicillin), cephalosporin-derived antibiotics, and penem antibiotics is not known. In addition to the results of the PRE-PEN skin test, the decision to administer or not administer penicillin should take into account individual patient factors. Healthcare professionals should keep in mind the following: 1.

A serious allergic reaction to therapeutic penicillin may occur in a patient with a negative skin test to PRE-PEN. 2. It is possible for a patient to have an anaphylactic reaction to therapeutic penicillin in the presence of a negative PRE-PEN skin test and a negative history of clinical penicillin hypersensitivity.

3. If penicillin is the drug of choice for a life-threatening infection, successful desensitization with therapeutic penicillin may be possible irrespective of a positive skin test and/or a positive history of clinical penicillin hypersensitivity. Pregnancy: Animal reproduction studies have not been conducted with PRE-PEN.

It is not known whether PRE-PEN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The hazards of skin testing in such patients should be weighed against the hazard of penicillin therapy without skin testing.

📄 Package Label / Principal Display Panel 197 words ▾

PRINCIPAL DISPLAY PANEL - Carton Label Carton Label Part No. PRPE399999 NDC 49471-001-05 benzylpenicilloyl polylysine Pre-Pen ® injection 6.0 x 10 -5 M (benzylpenicilloyl) For intradermal or subcutaneous use SKIN TEST ANTIGEN 5 x 0.25 mL single-dose ampules Rx Only Distributed by ALK -ABELLÓ Manufactured by Aller Quest , LLC GTIN 00349471001056 Serial No. 100001 Lot XXXXXX Exp XX/XX Made in USA © 2022 ALK-Abelló, Inc. © 2022 AllerQuest, LLC Dosage: See Prescribing information.

Each single-dose ampule contains 6 x 10 -5 M of benzylpenicilloyl in 0.25 mL solution and also contains

0.01 M monobasic sodium phosphate and

0.15M sodium chloride to adjust the ph to 7.6. Each ampule contains sufficient amount for both puncture and intradermal testing for a single patient only Discard unused portion No preservative Store refrigerated at 2° to 8°C (36°F to 46°F). PRE-PEN can be stored at room temperature up to 25°C (77°F) for 24 hours.

Discard PRE-PEN after 24 hours. Discard if particulate matter or discoloration present. NDC 49471-001-05 Part No.

PRPE399999 Manufactured by: AllerQuest, LLC Plainville, CT 06062 US License No. 2265 Product of USA Distributed by: ALK-Abelló, Inc. Port Washington, NY 11050 Principal Display Panel - Carton Label

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Benzylpenicilloyl polylysine — the ingredient across all brands.

Top reported reactions

Pruritus11
False Negative Investigation Result8
Urticaria6
Anaphylactic Reaction4
Skin Test Positive4
Erythema3
Feeling Hot3

Age at onset

Adolescent1

Reporter sex

34 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
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 ALK-ABELLO, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ALK-ABELLO, INC. 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.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 49464-0001-01 · Hubei 49479-0500-01 · Linde →
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.