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Rifadin rifampicin Kit — NDC 00068-0660-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rifadin rifampicin Kit — NDC 0068-0660-50 (Billing 00068-0660-50)

by Sanofi-Aventis U.S. LLC · 1 KIT in 1 CARTON * 10 mL in 1 VIAL * 10 mL in 1 AMPULE

This is a package of Rifadin rifampicin Kit from Sanofi-Aventis U.S. LLC, marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 00068-0660-50
🏷️ FDA NDC (as labeled) 0068-0660-50 billing pads the labeler segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Sep 10, 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 0068-0660-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0068 labeler · 0660 product · 50 package
Package marketed since
Aug 3, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
5015265300067
FDA record last changed
Sep 10, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0068-0660-50
Product NDC 0068-0660
11-digit billing NDC 00068066050
RxCUI 207436, 312821
UPC 5015265300067
SPL Set ID 1b074c23-dd35-43c9-820c-0e603481fdd3
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-03
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 207436
Why two NDCs? The FDA registers this code as 0068-0660-50 — a 4-4-2 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 labeler segment → 00068-0660-50. 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.

RxNorm drug class

This medicine belongs to the Rifamycin Antibacterial class.

Pharmacologic class Rifamycin Antibacterial
Drug family (ATC) Antibiotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

This is a kit formulation containing rifampicin, an antibiotic typically used to treat tuberculosis and certain other bacterial infections. Rifampicin is a prescription medication that functions as a broad-spectrum antimicrobial agent. This product is being distributed under an unapproved drug authorization issued during a drug shortage and has not received standard FDA approval through a completed application review.

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
00068-0660-50 You're viewing this Main listing 1 KIT in 1 CARTON * 10 mL in 1 VIAL * 10 mL in 1 AMPULE 2026-08-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rifadinthis 00068-0660-50 Sanofi-Aventis 1 kit — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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 & generic status

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerSanofi-Aventis U.S. LLC
Labeler code00068
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio85 products on file

More NDCs from Sanofi-Aventis U.S. LLC labeler code 00068

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. 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 ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🆘 Overdosage 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

3. How Rifadin Infusion is given Rifadin Infusion is given by a doctor or nurse. This is because it needs to be given as a slow drip into a vein (infusion).

How much is given If you are not sure why you are being given Rifadin Infusion or have any questions about how much Rifadin Infusion is being given to you, speak to your doctor or nurse. Tuberculosis (TB) The usual dose is: - Adults: A single daily dose of 600mg given over 2–3 hours - Children: Up to 20mg per kilogram of body weight each day. The maximum dose is 600mg each day.

Leprosy Your doctor may prescribe a monthly or daily dose - Patients weighing less than 50kg: A single daily dose of 450mg - Patients weighing more than 50kg: A single daily dose of 600mg Brucellosis, Legionnaires Disease or other serious bacterial infections The amount you are given will depend on how severe your infection is - Adults: 600mg–1200mg each day. The dose is given in 2–4 divided doses. Elderly patients Your doctor may need to monitor you more closely.

People with Liver problems You should not be given any more than 8mg per kilogram of body weight each day. If you are given more Rifadin Infusion than you should Your doctor will carefully calculate how much Rifadin Infusion you should get. Therefore, it is unlikely your doctor or nurse will give you too much of this medicine.

But, if you think that you have been given too much or too little Rifadin Infusion, tell your doctor or nurse. You may feel sick (nausea), be sick (vomiting), have stomach pain, itching or a headache. You may also feel tired, sleepy, dizzy or light-headed.

Other signs of having too much includes swelling of the face, eyes or eyelids, slurring of speech, difficulty breathing, fast heartbeat, uneven heartbeats, fits and heart attack. If you miss a dose of Rifadin Infusion Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed.

However, if you think you may have missed a dose, then talk to your doctor or nurse. Tests Having Rifadin Infusion may affect the results of some blood tests. In particular, tests for folate, vitamin B 12 and liver function.

If you are going to have a blood test, it is important to tell your doctor that you are having Rifadin Infusion.

⚠️ Warnings and Cautions ~3 min read ▾

Warnings and precautions Inform your doctor immediately while taking this medicine: ▲ If your symptoms of tuberculosis return or get worse (see section 4). Talk to your doctor, nurse or pharmacist before having Rifadin Infusion if: ▲ You have liver problems ▲ You have any kidney problems and if you are having more than 600mg rifampicin per day ▲ You have diabetes. Your diabetes may become more difficult to control while taking this medicine. ▲ You feel numb or weak in your arms and legs (peripheral neuropathy) ▲ You are under weight or malnourished ▲ You have a rare blood problem called 'porphyria' ▲ You have a problem with bleeding or a tendency to bruise easily ▲ You have a history of lung inflammation (interstitial lung disease/pneumonitis) ▲ Your symptoms of tuberculosis return or get worse (Please see section 4 Possible side effects) ▲ You develop a rash or experience any symptoms of thrombotic microangiopathy during your treatment (see section 4 Possible side effects) ▲ You wear contact lenses.

Having Rifadin Infusion may permanently stain soft contact lenses. ▲ The person having this medicine is a child ▲ You are aged 65 years or older If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Rifadin Infusion. Lung inflammation Inform your doctor immediately while having this medicine if you develop new or sudden worsening of shortness of breath, possibly with a dry cough or fever not responding to antibiotic treatment. These could be symptoms of lung inflammation (interstitial lung disease/pneumonitis) and can lead to serious breathing problems due to collection of fluid in the lungs and interfere with normal breathing which can lead to life threatening conditions.

Liver problems You should not have rifampicin, a component of Rifadin Infusion, if you have previously taken any rifampicin containing medicinal product and had liver problems. If you are unsure talk to your doctor. Inflammation of the liver has been reported in patients taking rifampicin with symptoms developing within a few days to a few months following the start of treatment.

Stop using rifampicin and contact a doctor if you have symptoms of liver problems (see section 4 Possible side effects). Serious skin reactions Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported with the use of Rifadin Infusion. SJS/TEN can appear initially as reddish target spots or circular patches often with central blisters on the trunk.

Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.

DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localized on the skin folds, trunk, and upper extremities.

The highest risk for occurrence of serious skin reactions is within 2 days to 2 months after treatment initiation depending on the condition. If you develop a serious rash or another of these skin symptoms, stop taking Rifadin Infusion and contact your doctor or seek medical attention immediately. Blood Tests Your doctor will need to check your blood before you are given this medicine.

This will help your doctor know if any changes happen to your blood after having this medicine. You may also need to have regular blood tests to check how your liver is working. Other me… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

4. Possible side effects Like all medicines, Rifadin Infusion can cause side effects, although not everybody gets them. Tell a nurse or doctor straight away if you notice any of the following serious side effects: You have an allergic reaction .

The signs may include: a rash, swallowing or breathing problems, wheezing, swelling of your lips, face, throat or tongue. Nausea (feeling sick) or vomiting (being sick) fever, feeling tired, loss of appetite (anorexia), dark-coloured urine, light-coloured faeces, yellowing of the skin or whites of the eyes, itching, rash or upper stomach pain. These symptoms may be signs of liver injury.

Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. See also section 2 .

Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). See also section 2 . A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalized exanthematous pustulosis).

See also section 2 . You bruise more easily than usual. Or you may have a painful rash of dark red spots under the skin which do not go away when you press on them (purpura).

This could be because of a serious blood problem. You have high blood levels of uric acid You have severe bleeding (haemorrhage) Paradoxical drug reaction - Symptoms of tuberculosis can return, or new symptoms can occur after initial improvement during treatment. Paradoxical reactions have been reported as early as 2 weeks and as late as 18 months after beginning anti-tuberculosis treatment.

Paradoxical reactions are typically associated with fever, swollen lymph nodes (lymphadenitis), breathlessness, and cough. Patients with paradoxical drug reaction can also experience headaches, loss of appetite, and weight loss. You have chills, tiredness, unusually pale skin colour, shortness of breath, fast heartbeat or dark-coloured urine.

This could be signs of a serious type of anaemia. You have blood in your urine or an increase or decrease in amount of urine you produce. You may also get swelling, especially of the legs, ankles or feet.

This may be caused by serious kidney problems. You have a sudden severe headache. This could be a sign of bleeding in the brain.

New or sudden worsening of shortness of breath and wheezing, possibly with a cough or fever. These could be symptoms of inflammation of the lungs (interstitial lung disease/pneumonitis). You get confused, sleepy, cold clammy skin, shallow or difficult breathing, a racing heartbeat or your skin is paler than normal.

These could be signs of shock. You get more infections more easily than normal. Signs include fever, sore throat or mouth ulcers.

This could be because you have a low number of white blood cells. You have bleeding from your nose, ear, gums, throat, skin or stomach. Signs may include a feeling of tenderness and swelling in your stomach, purple spots on your skin and black or tar-like stools.

Mental problems with unusual thoughts and strange visions (hallucinations) Severe watery diarrhoea that will not stop and you are feeling weak and have a fever. This may be something called 'Pseudomembranous colitis'. Flu-like symptoms including chills, fever, headache, dizziness and bone pains Inflammation of the liver – yellowing of the skin and white part of eyes, increase in the blood level of liver enzymes.

Blood clots in small blood vessels (thrombotic microangiopathy) – Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness. Your doctor… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage ~2 min read ▾

Overdose Human Experience Signs and Symptoms Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange colouration of the skin, urine, sweat, saliva, tears and faeces will occur, and its intensity is proportional to the amount ingested.

Facial or periorbital oedema has also been reported in paediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures and cardiac arrest were reported in some fatal cases. The minimum acute lethal or toxic dose is not well established.

However, nonfatal acute overdoses in adults have been reported with doses ranging from 9–12g rifampicin. Fatal acute overdoses in adults have been reported with doses ranging from 14 – 60g. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal reports.

Nonfatal overdoses in paediatric patients ages 1–4 years old of 100mg/kg for one to two doses have been reported. Management Intensive supportive measures should be instituted, and individual symptoms treated as they arise. Since nausea and vomiting are likely to be present, gastric lavage is probably preferable to induction of emesis.

Following evacuation of the gastric contents, the instillation of activated charcoal slurry into the stomach may help absorb any remaining drug from the gastrointestinal tract. Antiemetic medication may be required to control severe nausea and vomiting. Active diuresis (with measured intake and output) will help promote excretion of the drug.

Haemodialysis may be of value in some patients. Incompatibilities Compatibilities: up to 6 hours with Saline Solution and up to 8 hours with Glucose 5%. Incompatibilities: Perfudex, Sodium Bicarbonate 5%, Sodium Lactate 0.167M, Ringer Acetate with Glucose.

Shelf life Unopened vial of lyophilisate: 36 months Unopened ampoule of solvent: 60 months Shelf life after dilution or reconstitution: Up to 30 hours with Water for injections (10ml WFI) Up to 8 hours with Water for injections (10ml WFI) and then diluted in glucose 5% solution for infusion Up to 6 hours with Water for injections (10ml WFI) and then diluted in sodium chloride 0.9% solution for infusion Special precautions for storage Store below 25°C.

📦 How Supplied / Storage and Handling 97 words ▾

5. How to store Rifadin Infusion This medicine will be kept by your doctor or nurse in a safe place out of the sight and reach of children. Do not use Rifadin Infusion after the expiry date which is stated on the carton and label after EXP.

The expiry date refers to the last day of that month. Store below 25°C You will not be asked to store your medicine. It will be brought to you ready to be given straight away.

Do not throw away any medicines via wastewater. These measures will help protect the environment

📦 Storage and Handling 39 words ▾

Store below 25°C You will not be asked to store your medicine. It will be brought to you ready to be given straight away. Do not throw away any medicines via wastewater. These measures will help protect the environment

📄 Patient Package Insert ~2 min read ▾

Is this leaflet hard to see or read? Phone 0800 035 2525 for help Important things you need to know about Rifadin Infusion You must keep taking it until your doctor tells you to stop. If you are having any other medicines, including medicines you have bought from the pharmacy or shop, you must make sure your doctor knows.

Rifadin Infusion makes all your body fluids an orange or red colour. Do not worry – this is normal and not harmful. If you get a temperature, are sick, begin to feel more unwell, lose your appetite or have yellowing of the skin, gums or eyes, you must talk to your doctor straight away.

Read the rest of this leaflet carefully before you start having this medicine. Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it to others.

It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What is in this leaflet What Rifadin Infusion is and what it is used for What you need to know before you take Rifadin Infusion How Rifadin Infusion is given Possible side effects How to store Rifadin Infusion Contents of the pack and other information 1. What Rifadin Infusion is and what it is used for Rifadin Infusion contains a medicine called rifampicin. It belongs to a group of medicines called anti-infectives.

It works by killing the bacteria that cause infections. Rifadin Infusion is used to treat the following bacterial infections when medicines cannot be given by mouth: Tuberculosis (also known as TB) alongside other medicines Leprosy alongside other medicines Brucellosis alongside other medicines Legionnaires Diseases alongside other medicines Other serious bacterial infections 2. What you need to know before you take Rifadin Infusion Do not have Rifadin Infusion if: X You are allergic (hypersensitive) to - rifampicin - any of the other ingredients of the Rifadin Infusion (see Section 6) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

X You have yellowing of the skin and eyes (jaundice) X You are taking saquinavir or ritonavir for an HIV infection (see ' Other medicines and Rifadin Infusion ' below) X You are currently taking any of the following medicines: - sofosbuvir - antiviral medicine for treatment of hepatitis C virus infections - cabotegravir, fostemsavir, lenacapavir – HIV medicines - lurasidone (medicine for schizophrenia and bipolar disorders) as rifampicin may reduce the blood levels of several medicines including the above listed. Do not have if any of the above apply to you.

If you are not sure, talk to your doctor, nurse or pharmacist before having Rifadin Infusion.

📄 Package Label / Principal Display Panel 77 words ▾

PRINCIPAL DISPLAY PANEL - 600 mg Vial Label 600mg Rifadin ® infusion rifampicin For IV infusion only 20ml vial 89019730 PRINCIPAL DISPLAY PANEL - 600 mg Vial Label

PRINCIPAL DISPLAY PANEL - 10 mL Ampule Carton 600mg Rifadin ® infusion rifampicin For intravenous infusion only 10ml ampoule containing solvent to be added to 20ml vial containing 600mg Rifampicin Important update on compatibilities with diluents. Please see Technical Leaflet sanofi PRINCIPAL DISPLAY PANEL - 10 mL Ampule Carton

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 Rifadin (this brand).

Top reported reactions

Drug Interaction1,005
Pyrexia917
Drug Reaction With Eosinophilia And Systemic Symptoms558
Vomiting452
Drug-induced Liver Injury443
Nausea393
Acute Kidney Injury362

Age at onset

Neonate32
Infant24
Child60
Adolescent44
Adult930
Elderly461

Reporter sex

10,058 reports
Male · 55%
Female · 44%
Unknown · 1%

Serious outcomes

Hospitalization4,796
Death1,593
Life-threatening885
Disabling245
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,023 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 Marketed without an FDA application Kit / multi-component package

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 — 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug For Use In Drug Shortage". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Sanofi-Aventis U.S. LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sanofi-Aventis U.S. 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.
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.
← 00068-0597-01 · Sanofi-Aventis 00069-0043-01 · Pfizer →
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.