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Fluorescein 500 mg/mL Injection — NDC 14789-0122-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Fluorescein 500 mg/mL Injection — NDC 14789-122-05 (Billing 14789-0122-05)

by Nexus Pharmaceuticals LLC · 10 VIAL in 1 CARTON / 5 mL in 1 VIAL

This is a package of Fluorescein 500 mg/mL Injection from Nexus Pharmaceuticals LLC, marketed since Oct 2023 and currently FDA-listed. It is this product's only package size.

NDC 14789-0122-05
🏷️ FDA NDC (as labeled) 14789-122-05 billing pads the product segment with a zero
Rx only Generic 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 14789-122-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
14789 labeler · 122 product · 05 package
Package marketed since
Oct 24, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0314789122052
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 14789-122-05
Product NDC 14789-122
11-digit billing NDC 14789012205
NCPDP billing unit ML — per mL (volume)
UNII TPY09G7XIR
UPC 0314789122052
Application # ANDA215709
SPL Set ID 0a2a65b1-dc88-445b-bfb7-53b2fd7bea2c
Established class (EPC) Diagnostic Dye
Mechanism of action Dyes
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-24
Route INTRAVENOUS
Dosage form INJECTION
Substance FLUORESCEIN
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 006830
GCN 27760
HICL code 002908
Ingredient (HICL) Fluorescein Sodium
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q2
Therapeutic class — intermediate (HIC2) Drugs Acting On The Eye
HIC3 code Q2U
Therapeutic class — specific (HIC3) Eye Diagnostic Agents
AHFS code 36:58.00.00
AHFS class Ocular Disorders
FDB label name FLUORESCEIN 10% 500 MG/5 ML VL
FDB brand name Fluorescein Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006830
  • GCN: 27760
  • HICL (First Databank): 002908
  • AHFS class code: 36:58.00.00
Why two NDCs? The FDA registers this code as 14789-122-05 — 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 → 14789-0122-05. 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 FLUORESCEIN 10% 500 MG/5 ML VL Ingredient Fluorescein Sodium

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
14789-0122-05 You're viewing this Main listing 10 VIAL in 1 CARTON / 5 mL in 1 VIAL 2023-10-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluorescein 500 mg/mLthis 14789-0122-05 Nexus 10 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

LabelerNexus Pharmaceuticals LLC
Application holderNEXUS PHARMACEUTICALS LLC
FDA applicationANDA215709 (ANDA)
Labeler code14789
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio14 products on file

More NDCs from Nexus Pharmaceuticals LLC labeler code 14789

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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 50 words ▾

1. INDICATIONS & USAGE Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. Fluorescein Injection, USP is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2. DOSAGE & ADMINISTRATION The normal adult dose of Fluorescein Injection 10%, is 5 mL (500 mg) and of Fluorescein Injection 25%, is 2 mL (500 mg) via intravenous administration. ( 2.1 ) For children, the dose should be calculated on the basis of 35 mg for each ten pounds of body weight (7.7 mg/kg body weight). ( 2.2 ) Do not mix or dilute with other solutions or drugs. ( 2.2 )

2.1Dosing Adult Dose The recommended dosage of Fluorescein Injection 10% (100 mg/mL) and of Fluorescein Injection 25% (250 mg/mL) is 500 mg via intravenous administration. Pediatric Dose For children, the dose is 7.7 mg/kg (actual body weight) up to a maximum of 500 mg, via intravenous infusion calculated on the basis of 35 mg for each 10 lbs. (4.54 kg) of body weight.

2.2Preparation for Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not mix or dilute with other solutions or drugs. Discard unused portion.

2.3Administration Inject the dose (over 5-10 seconds is normally recommended) into the antecubital vein, after taking precautions to avoid extravasation. A syringe, fi led with Fluorescein, may be attached to transparent tubing and a 23 gauge butterfly needle for injection. Insert the needle and draw the patient's blood to the hub of the syringe so that a small air bubble separates the patient's blood in the tubing from the fluorescein.

With the room lights on, slowly inject the blood back into the vein while watching the skin over the needle tip. If the needle has extravasated, the patient's blood will be seen to bulge the skin and the injection should be stopped before any fluorescein is injected. When assured that extravasation has not occurred, the room light may be turned off and the fluorescein injection completed.

Luminescence usually appears in the retina and choroidal vessels in 7 to 14 seconds and can be observed by standard viewing equipment. Reduction in dose from 500 mg to 200 mg Fluorescein Injection, 10% may be appropriate in cases when a highly sensitive imaging system e.g., scanning laser ophthalmoscope is used.

💊 Dosage Forms and Strengths 57 words ▾

3. DOSAGE FORMS & STRENGTHS Fluorescein Injection 10%, 100 mg/mL in a 5 mL single-dose vial. Fluorescein Injection 25%, 250 mg/mL in a 2 mL single-dose vial. Fluorescein Injection 10%, 100 mg/mL in a 5 mL single dose vial ( 3 ) Fluorescein Injection 25%, 250 mg/mL in a 2 mL single dose vial ( 3 )

⛔ Contraindications 58 words ▾

4. CONTRAINDICATIONS Hypersensitivity to any component of this product. ( 4.1 )

4.1Hypersensitivity Fluorescein Injection, USP is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported [see WARNINGS AND PRECAUTIONS ( 5.1 ) and ADVERSE REACTIONS ( 6.2 )] .

⚠️ Warnings and Cautions 198 words ▾

5. WARNINGS AND PRECAUTIONS Respiratory reactions. ( 5.1 ) Severe local tissue damage. ( 5.2 )

5.1Respiratory Reactions Caution should be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should always be available. If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection.

Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein.

5.2Severe local tissue damage Extravasation during injection can result in severe local tissue damage due to high pH of fluorescein solution. The following complications resulting from extravasation of fluorescein have been noted to occur: Sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median nerve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours.

When extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented. [see ADMINISTRATION ( 2.3 ) and ADVERSE REACTIONS ( 6.6 )] .

🤒 Adverse Reactions ~1 min read ▾

6. ADVERSE REACTIONS The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lambda Therapeutics Limited at 1-855-642-2594or email: [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ( 6 )

6.1Skin and urine discoloration The most common reaction is discoloration of the skin and urine. Skin will attain a temporary ye lowish discoloration. Urine attains a bright ye llow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours.

6.2Gastrointestinal Reaction The next most common adverse reaction is nausea. Vomiting, and gastrointestinal distress have also occurred. A strong taste may develop after injection.

6.3Hypersensitivity Reactions Symptoms and signs of hypersensitivity have occurred. Generalized hives and itching, bronchospasm and anaphylaxis have been reported. [see CONTRAINDICATIONS ( 4.1 ) and WARNINGS AND PRECAUTIONS ( 5.1 )] .

6.4Cardiopulmonary Reactions Syncope and hypotension may occur. Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely [see WARNINGS AND PRECAUTIONS ( 5.1 )] .

6.5Neurologic Reactions Headache may occur. Convulsions may rarely occur following injection.

6.6Thrombophlebitis Thrombophlebitis at the injection site has been reported. Extravasation of the solution at the injection site causes intense pain at the site and a dull aching pain in the injected arm. [see ADMINISTRATION ( 2.3 ) and WARNINGS AND PRECAUTIONS ( 5.2 )] .

👥 Use in Specific Populations 140 words ▾

8. USE IN SPECIFIC POPULATIONS Caution should be exercised when fluorescein sodium is administered to a nursing woman. ( 8.3 )

8.1Pregnancy Pregnancy Category C. Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. Fluorescein sodium should be given to a pregnant woman only if clearly needed.

8.3Nursing Mothers Fluorescein sodium has been demonstrated to be excreted in human milk. Caution should be exercised when fluorescein sodium is administered to a nursing woman.

8.4Pediatric Use Pediatric patients have been included in clinical studies. No overall differences in safety or effectiveness have been observed between pediatric and adult patients.

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

🤰 Pregnancy 47 words ▾

8.1Pregnancy Pregnancy Category C. Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. Fluorescein sodium should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 26 words ▾

8.4Pediatric Use Pediatric patients have been included in clinical studies. No overall differences in safety or effectiveness have been observed between pediatric and adult patients.

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

🧬 Clinical Pharmacology ~1 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465 to 490 nm and fluoresces, i.e., emits light at wavelengths of 520 to530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish green. Following intravenous injection of fluorescein sodium in an aqueous solution, the unbound fraction of the fluorescein can be excited with a blue light flash from a fundus camera as it circulates through the ocular vasculature, and the ye lowish green fluorescence of the dye is captured by the camera.

In the fundus, the fluorescence of the dye demarcates the retinal and/or choroidal vasculature under observation, distinguishing it from adjacent areas/structures.

12.3Pharmacokinetics Distribution. Within 7 to 14 seconds after IV administration into the antecubital vein, fluorescein usually appears in the central retinal artery of the eye. Within a few minutes of IV administration of fluorescein sodium, a ye lowish discoloration of the skin occurs, which begins to fade 6 to 12 hours after dosing.

Various estimates of volume of distribution indicate that fluorescein distributes into interstitial space (0.5 L/kg). Metabolism. Fluorescein is metabolized to fluorescein monoglucuronide.

After IV administration of fluorescein sodium (14 mg/kg) to 7 healthy subjects, approximately 80% of fluorescein in plasma was converted to glucuronide conjugate after a period of 1 hour post dose. Excretion. Fluorescein and its metabolite are mainly eliminated via renal excretion.

After IV administration, the urine remains slightly fluorescent for 24 to 36 hours. A renal clearance of 1.75 mL/min/kg and a hepatic clearance (due to conjugation) of 1.50 mL/min/kg have been estimated. The systemic clearance of fluorescein was essentia ly complete by 48 to 72 hours after administration of 500 mg fluorescein.

🧬 Mechanism of Action 116 words ▾

12.1Mechanism of Action Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465 to 490 nm and fluoresces, i.e., emits light at wavelengths of 520 to530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish green. Following intravenous injection of fluorescein sodium in an aqueous solution, the unbound fraction of the fluorescein can be excited with a blue light flash from a fundus camera as it circulates through the ocular vasculature, and the ye lowish green fluorescence of the dye is captured by the camera.

In the fundus, the fluorescence of the dye demarcates the retinal and/or choroidal vasculature under observation, distinguishing it from adjacent areas/structures.

📦 How Supplied / Storage and Handling 116 words ▾

16. HOW SUPPLIED Fluorescein Injection 10%, is supplied in a single-dose 5 mL glass vial with a gray bromobutyl serum siliconized stopper and orange flip-off cap. It contains a sterile dark reddish orange solution of fluorescein sodium.

(NDC 14789-122-05) 5 mL, single dose vials in a package of 10. Fluorescein Injection 25%, is supplied in a single-dose 2 mL glass vial with a gray bromobutyl serum siliconized stopper and orange flip-off cap. It contains a sterile dark reddish orange solution of fluorescein sodium.

(NDC 14789-123-05) 2 mL, single dose vials in a package of 10. Fluorescein Injection, USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

📋 Description 138 words ▾

11. DESCRIPTION Fluorescein Injection, is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%.

Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt. The active ingredient is represented by the chemical structure: MW = 376.27 Fluorescein Injection 10% contains: Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL) Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. Fluorescein Injection 25% contains: Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL) Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.

Chemical Structure

💬 Information for Patients 72 words ▾

17. PATIENT COUNSELING INFORMATION After administration of Fluorescein sodium, skin will attain a temporary yellowish discoloration. Urine attains a bright yellow color.

Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours. [see WARNINGS AND PRECAUTIONS AND ADVERSE REACTIONS ( 6.1 )] . Rx only Manufactured in Italy for: Nexus Pharmaceuticals LLC. 400 Knightsbridge Parkway Lincolnshire, IL 60069 FLRPI01ITR01 Rev.

05/2023

🍼 Nursing Mothers 27 words ▾

8.3Nursing Mothers Fluorescein sodium has been demonstrated to be excreted in human milk. Caution should be exercised when fluorescein sodium is administered to a nursing woman.

🧬 Pharmacokinetics 170 words ▾

12.3Pharmacokinetics Distribution. Within 7 to 14 seconds after IV administration into the antecubital vein, fluorescein usually appears in the central retinal artery of the eye. Within a few minutes of IV administration of fluorescein sodium, a ye lowish discoloration of the skin occurs, which begins to fade 6 to 12 hours after dosing.

Various estimates of volume of distribution indicate that fluorescein distributes into interstitial space (0.5 L/kg). Metabolism. Fluorescein is metabolized to fluorescein monoglucuronide.

After IV administration of fluorescein sodium (14 mg/kg) to 7 healthy subjects, approximately 80% of fluorescein in plasma was converted to glucuronide conjugate after a period of 1 hour post dose. Excretion. Fluorescein and its metabolite are mainly eliminated via renal excretion.

After IV administration, the urine remains slightly fluorescent for 24 to 36 hours. A renal clearance of 1.75 mL/min/kg and a hepatic clearance (due to conjugation) of 1.50 mL/min/kg have been estimated. The systemic clearance of fluorescein was essentia ly complete by 48 to 72 hours after administration of 500 mg fluorescein.

🧪 Nonclinical Toxicology 24 words ▾

13. NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 21 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.

📄 Package Label / Principal Display Panel 82 words ▾

Principal Display Panel – 5 mL Carton Label Rx Only NDC 14789-122-05 Fluorescein Injection, USP 10% 500 mg / 5 mL (100 mg/mL) 10 x 5 mL Sterile Single-dose Vials NEXUS PHARMACEUTICALS Principal Display Panel – 5 mL Carton Label

Principal Display Panel – 5 mL Vial Label NDC 14789-122-07 Rx Only Fluorescein Injection, USP 10% 500 mg/5 mL (100 mg/mL) 5 mL Sterile Single-dose Vial For Intravenous Injection. Discard unused portion NEXUS PHARMACEUTICALS Principal Display Panel – 5 mL Vial Label

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
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 ✓ Available
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 Nexus Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nexus Pharmaceuticals 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.
← 14789-0121-05 · Nexus 14789-0123-05 · Nexus →
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.