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ORALTAG Iohexol 4.5 g For Solution, 12 pouches — NDC 54702-501-52 (Billing 54702-0501-52)

by Interpharma Praha, a.s. · 12 POUCH in 1 CASE / 1 BOTTLE, PLASTIC in 1 POUCH / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC

This is a package of 12 pouches of ORALTAG Iohexol 4.5 g For Solution from Interpharma Praha, a.s., no longer marketed, no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 3 package sizes.

NDC 54702-0501-52
🏷️ FDA NDC (as labeled) 54702-501-52 billing pads the product segment with a zero
This package
Contains12 pouches Pack sizes3 compare ↓
Main listing for product 54702-501 · Also comes in: 12 pouches 54702-501-98 25 pouches 54702-501-62
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 18, 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

⚠️
Other active recalls for Iohexol (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 24, 2026 — Presence of particulate matter (GE Healthcare Ireland Limited) · FDA recall D-0448-2026
Class II · Mar 24, 2026 — Presence of particulate matter (GE Healthcare Ireland Limited) · FDA recall D-0447-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54702-501-52
Product NDC 54702-501
11-digit billing NDC 54702050152
Application # NDA205383
SPL Set ID fdeb1668-7126-48f7-aaf9-1dc3beb90bac
Mechanism of action Radiographic Contrast Agent [EPC], X-Ray Contrast Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route ORAL
Dosage form FOR SOLUTION
Substance IOHEXOL
Why two NDCs? The FDA registers this code as 54702-501-52 — 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 → 54702-0501-52. 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

📗 Our plain-language guide HelloPharmacist
  • It is a contrast dye that makes X-rays and CT scans easier to read. Depending on the product, it can be used to look at the spine, blood vessels, urinary system, digestive tract, j...
  • Staff will give it by injection or by mouth, depending on the scan. The label advises staying well hydrated before and after an injection. Oraltag is mixed with a drink and taken 2...
  • How will I get it, and do I need to prepare?
  • They vary by route. After a spinal injection, headache, back pain and nausea are common. Swallowed forms often cause diarrhea, nausea or belly pain. Injection into a vessel can cau...
📖 Read our full Iohexol guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo 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: 12 pouches 25 pouches
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
54702-0501-52 You're viewing this Main listing 12 POUCH in 1 CASE / 1 BOTTLE, PLASTIC in 1 POUCH / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC 2016-07-01 — Inactivated by FDA
54702-0501-62 54702-501-62 25 POUCH in 1 CASE / 1 BOTTLE, PLASTIC in 1 POUCH / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC 2016-07-01 — Inactivated by FDA
54702-0501-98 54702-501-98 12 POUCH in 1 CASE / 1 BOTTLE, PLASTIC in 1 POUCH / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC 2016-07-01 — Inactivated by FDA

Pack size FAQ

What quantity is in this package?
This package contains 12 pouches — 12 pouch in 1 case / 1 bottle, plastic in 1 pouch / 1 for solution in 1 bottle, plastic.
How does this package differ from NDC 54702-0501-98?
Both are ORALTAG Iohexol 4.5 g For Solution — the drug itself is identical. This page's package is the 12 pouches one, while NDC 54702-0501-98 is the 12 pouches package.
What NDC number is used to bill for this package of ORALTAG Iohexol 4.5 g For Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oraltag 4.5 gthis 54702-0501-52 Interpharma 12 pouches — — Discontinued —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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
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.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerInterpharma Praha, a.s.
Application holderINTERPHARMA PRAHA AS
FDA applicationNDA205383 (NDA)
Labeler code54702
Product typeHuman Prescription Drug
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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 90 words ▾

1 INDICATIONS AND USAGE Oraltag is indicated for use in computed tomography of the abdomen and pelvis to opacify bowel loops and delineate between normal loops and adjacent organs or areas of suspected pathology. Limitations of Use Oraltag is not indicated for diagnostic examination of the gastrointestinal tract. Oraltag is a radiographic contrast agent indicated for use in opacification of the gastrointestinal tract during computed tomography (CT) of the abdomen and pelvis ( 1 ) Limitations of Use Not indicated for diagnostic examination of the gastrointestinal tract ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION For oral use only: Adults : 1 to 2 bottles (4.5 g to 9 g iodine (I)) ( 2 ) Pediatric patients 3 to 18 years of age : less than 1 bottle to 2 bottles (less than 4.5 gI up to 9 gI) ( 2 ) Pediatric patients less than 3 years of age : up to 1 bottle (4.5 gI) ( 2 )

2.1Recommended Dosing For oral use only [see Warnings and Precautions (5.1) ] Refer to Table 1 for dosing information. Table 1 Dosing Guidelines for Oraltag Patient Age Recommended Dose Total volume of Oraltag administered will vary depending on the size of the patient Volume of Prepared Solution to Administer (at a concentration of 9 mgI per mL) Maximum Total Iodine Dose Adults Administer 4.5 g to 9 g of iodine (1 to 2 bottles of prepared solution), orally 500 mL to 1000 mL 9 grams 3 to 18 years of age Administer up to 9 g of iodine (from less than 1 bottle up to 2 bottles of prepared solution), orally 280 mL to 750 mL, depending on size of patient 9 grams Less than 3 years of age Administer up to 4.5 g of iodine (portion of 1 bottle of prepared solution), orally 120 mL to 300 mL, depending on size of patient 4.5 grams The variables of patient age, weight, or medical condition, may require adjustment of the concentration and/or volume of solution to be prepared for administration.

If it is anticipated that the patient will have difficulty in consuming the required volume, a higher concentration of solution (up to 21 mgI per mL) can be prepared and a smaller volume administered (see Table 2). Table 2 Preparation of Higher Concentrations of Oraltag at Lower Volumes For Final Concentration (mgI/mL) Add Water or a Beverage Examples include infant formula, milk, juice, carbonated beverage or a sports drink to the Indicated Mark on the Bottle (mL) 9 500 12 375 15 300 18 250 21 214

2.2Preparation and Administration Instructions Reconstitute Oraltag, supplied as a powder in a single use bottle, with water or other beverages just before its use Do not mix other pharmaceuticals with Oraltag Use the 5 fill lines premolded and labeled on the bottle to determine the volume for the 5 target concentrations (9, 12, 15, 18, and 21 mgI/mL) Administer Oraltag 20 to 60 minutes before image acquisition Protect prepared solution from strong daylight and direct exposure to sunlight Discard any unused portions

💊 Dosage Forms and Strengths 51 words ▾

3 DOSAGE FORMS AND STRENGTHS For oral solution: Oraltag is provided as a white to off-white powder of 9.7 g iohexol, (equivalent to 4.5 g of carbon bound iodine) in a single-use bottle. For oral solution: Each single use bottle contains 9.7 g iohexol (equivalent to 4.5 g carbon bound iodine)

⛔ Contraindications 31 words ▾

4 CONTRAINDICATIONS Oraltag is contraindicated in patients with a known hypersensitivity to iodinated contrast agents, including iohexol [see Warnings and Precautions (5.2) ] . Hypersensitivity to iodinated contrast agents, including iohexol

⚠️ Warnings and Cautions 179 words ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: life-threatening or fatal reactions can occur. Resuscitation equipment and personnel should be available ( 5.2 ) Thyroid function test alterations: Oraltag may alter tests which depend on iodine estimation. Perform such tests prior to Oraltag administration ( 5.3 )

5.1Risks Associated with Inadvertent Parenteral Administration Oraltag is not a sterile product and is not suitable for a parenteral route of administration. Serious adverse reactions such as sepsis can occur if administered parenterally. Do not administer Oraltag parenterally.

5.2Hypersensitivity Reactions Administration of Oraltag can cause life-threatening hypersensitivity reactions including anaphylaxis [see Contraindications (4) ] . Patients at increased risk include those with a previous reaction to an iodinated contrast agent and allergic disorders (i.e., bronchial asthma, allergic rhinitis, and food allergies). Emergency resuscitation equipment and trained personnel should be available.

5.3Alteration of Thyroid Function Tests Iodinated contrast agents may alter the results of thyroid function tests which depend on iodine estimation, e.g., radioactive iodine uptake test. Therefore, such testing, if indicated, should be performed prior to the administration of this preparation.

🤒 Adverse Reactions 146 words ▾

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Hypersensitivity reactions [see Warnings and Precautions (5.2) ] The most common adverse reactions (incidence < 2%) are nausea, vomiting, and diarrhea ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Interpharma Praha at 1-877-886-7040 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience In studies involving 44 adult and 69 pediatric patients who received oral and intravenous iohexol for CT examinations of the abdomen, two reports of vomiting (2%) were noted.

6.2Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been reported following oral administration of the dilute, hypotonic solutions of iohexol (9 mgI/mL to 21 mgI/mL): Gastrointestinal: nausea, diarrhea

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no human data on risks associated with the use of Oraltag during pregnancy. The background risk in the U.S. general population of major birth defects is 2% to 4% and risk of miscarriage is 15% to 20% of clinically recognized pregnancies. In animal reproduction studies, no evidence of fetal harm was observed with intravenous administration of iohexol to rats and rabbits at doses up to 100 times the maximum recommended human intravenous dose.

8.2Lactation Risk Summary Iohexol administered intravenously is present in human milk at concentrations approximately 0.5% of the maternal dose; however, it is not known to what extent iohexol administered orally is present in human milk. Iodinated contrast is poorly excreted into human milk and is poorly absorbed by the gastrointestinal tract of a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Oraltag and any potential adverse effects on the breastfed infant from Oraltag.

Clinical Considerations Interruption of breastfeeding after exposure to iodinated contrast media is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 half-lives) after Oraltag administration in order to minimize potential drug exposure to a breastfed infant.

8.4Pediatric Use The safety and effectiveness of oral iohexol have been established in pediatric patients.

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🤰 Pregnancy 79 words ▾

8.1Pregnancy Risk Summary There are no human data on risks associated with the use of Oraltag during pregnancy. The background risk in the U.S. general population of major birth defects is 2% to 4% and risk of miscarriage is 15% to 20% of clinically recognized pregnancies. In animal reproduction studies, no evidence of fetal harm was observed with intravenous administration of iohexol to rats and rabbits at doses up to 100 times the maximum recommended human intravenous dose.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of oral iohexol have been established in pediatric patients.

🧓 Geriatric Use 43 words ▾

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🧬 Clinical Pharmacology 119 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Iohexol enhances imaging due to its high iodine content attenuating the beam of X-rays during CT examinations. Different tissues within the body attenuate X-rays to different degrees, and oral administration of iohexol allows for enhanced visualization due to the iodine present in bowel loops.

12.3Pharmacokinetics Orally administered iohexol is very poorly absorbed from the normal gastrointestinal tract. Only 0.1 to 0.5% of the oral dose is excreted by the kidneys. This amount may increase in the presence of bowel perforation, bowel obstruction, or severe inflammatory bowel disease.

Iohexol displays a low affinity for serum or plasma proteins and is poorly bound to serum albumin. No significant metabolism, deiodination or biotransformation occurs.

🧬 Mechanism of Action 48 words ▾

12.1Mechanism of Action Iohexol enhances imaging due to its high iodine content attenuating the beam of X-rays during CT examinations. Different tissues within the body attenuate X-rays to different degrees, and oral administration of iohexol allows for enhanced visualization due to the iodine present in bowel loops.

📦 How Supplied / Storage and Handling 106 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Oraltag is supplied as a nonsterile white to off-white powder for oral solution in a single-use 20-ounce polyethylene terephthalate beverage bottle closed with a lined polypropylene cap. Each bottle is packaged in a sealed foil pouch. Twelve (12) bottles per pack (NDC 54702-501-52).

Twenty-five (25) bottles per pack (NDC 54702-501-62). Storage Store at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect prepared solutions of Oraltag from strong daylight and direct exposure to sunlight.

Do not use if tamper-evident foil pouch has been opened.

📋 Description 133 words ▾

11 DESCRIPTION Oraltag (iohexol) is a radiographic contrast agent for oral solution. Oraltag is provided as a nonsterile white to off-white powder with 9.7 g iohexol (equivalent to 4.5 g of carbon bound iodine) in a 20-ounce beverage bottle. Each bottle is individually sealed in a foil laminated pouch.

Oraltag consists of 100 percent iohexol and contains no excipients. Iohexol is designated chemically as N,N´-bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide. It is a nonionic, water-soluble iodinated contrast medium with a molecular weight of 821.14 (carbon bound iodine content 46.36%).

In aqueous solution each triiodinated molecule remains undissociated. The chemical structure is: Oraltag, when prepared at a concentration of 9 mgI/mL in water, has an osmolality of 30 mOsmol/kg water. The calculated osmolality of 21 mgI/mL in water is 55 mOsmol/kg water.

The prepared solutions are hypotonic. Chemical Structure

💬 Information for Patients 39 words ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise patients about the risk of hypersensitivity reactions to Oraltag and the need to notify their healthcare provider if signs or symptoms of hypersensitivity reaction occur [see Warnings and Precautions (5.2) ] .

🧬 Pharmacokinetics 68 words ▾

12.3Pharmacokinetics Orally administered iohexol is very poorly absorbed from the normal gastrointestinal tract. Only 0.1 to 0.5% of the oral dose is excreted by the kidneys. This amount may increase in the presence of bowel perforation, bowel obstruction, or severe inflammatory bowel disease.

Iohexol displays a low affinity for serum or plasma proteins and is poorly bound to serum albumin. No significant metabolism, deiodination or biotransformation occurs.

🧪 Nonclinical Toxicology 54 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential or mutagenesis. In animal reproduction studies, no evidence of impaired fertility was observed with intravenous administration of iohexol to rats and rabbits at doses up to 100 times the maximum recommended human intravenous dose.

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

PRINCIPAL DISPLAY PANEL - 9.7 g Bottle Label NDC 54702-501-21 Oraltag™ (iohexol) for oral solution 9.7 g of iohexol powder (equivalent to 4.5 g of carbon bound iodine) Single Use Bottle - Discard Unused Portion Prepared solution is 9-21 mgI/mL For Oral Use Only Nonsterile For indications and dosage, see prescribing information. Store at 20-25˚C (68-77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP] Protect prepared solutions of Oraltag from strong daylight and direct exposure to sunlight. Rx Only Manufactured for Interpharma Praha, a.s.

Prague, Czech Republic by Ultra Seal Corporation New Paltz, New York PRINCIPAL DISPLAY PANEL - Bottle Label

PRINCIPAL DISPLAY PANEL - Foil Pouch Label NDC 54702-501-51 Oraltag™ (iohexol) for oral solution Contains a single-use bottle with 9.7 g of iohexol powder (equivalent to 4.5 g of carbon bound iodine) For Oral Use Only Nonsterile Store at 20-25˚C (68-77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP] Rx Only Manufactured for Interpharma Praha, a.s. Prague, Czech Republic by Ultra Seal Corporation New Paltz, New York Instructions for Use: 1. Add water or beverage up to the fill line on the bottle as prescribed for the patient.

Prepare one or two bottles as directed. 2. Replace cap and shake until all the powder has dissolved.

3. The dose is ready to be consumed by the patient. 4.

Discard any unused portion. PRINCIPAL DISPLAY PANEL - Pouch Label Front PRINCIPAL DISPLAY PANEL - Pouch Label Back

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

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 12 pouches (54702-0501-98), 25 pouches (54702-0501-62). 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?
Interpharma Praha, a.s. 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.
← 54660-0004-00 · Societe 54706-0001-01 · Garrett →
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.