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AK-FLUOR fluorescein 100 mg/mL Injection — NDC 81298-8660-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AK-FLUOR fluorescein 100 mg/mL Injection — NDC 81298-8660-3 (Billing 81298-8660-03)

by Long Grove Pharmaceuticals, LLC · 12 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS

This is a package of AK-FLUOR fluorescein 100 mg/mL Injection from Long Grove Pharmaceuticals, LLC, marketed since Sep 2024 and currently FDA-listed. It is this product's only package size.

NDC 81298-8660-03
🏷️ FDA NDC (as labeled) 81298-8660-3 billing pads the package 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 81298-8660-3 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
81298 labeler · 8660 product · 3 package
Package marketed since
Sep 28, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0381298866036
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 81298-8660-3
Product NDC 81298-8660
11-digit billing NDC 81298866003
NCPDP billing unit ML — per mL (volume)
UNII 93X55PE38X
UPC 0381298866036
Application # NDA022186
SPL Set ID 73511e79-c050-4dc0-aa2f-a79ed320b5b0
Established class (EPC) Diagnostic Dye
Mechanism of action Dyes
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-28
Route INTRAVENOUS
Dosage form INJECTION
Substance FLUORESCEIN SODIUM
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 AK-FLUOR 10% (500 MG/5 ML) VL
FDB brand name Ak-Fluor
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 81298-8660-3 — a 5-4-1 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 package segment → 81298-8660-03. 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 AK-FLUOR 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
81298-8660-03 You're viewing this Main listing 12 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS 2024-09-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluorescein 100 mg/mL 51662-1533-03 HF 12 pouches — AP FDA listed —
Fluorescein 100 mg/mL 70771-1969-09 Zydus 12 vials — — FDA listed —
Ak-Fluor 100 mg/mLthis 81298-8660-03 Long 12 vials — AP FDA listed —
Fluorescein 100 mg/mL 70710-2045-09 Zydus 12 vials — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

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

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

3 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

LabelerLong Grove Pharmaceuticals, LLC
Application holderLONG GROVE PHARMACEUTICALS LLC
FDA applicationNDA022186 (NDA)
Labeler code81298
First marketedSep 2024
Product typeHuman Prescription Drug
Portfolio14 products on file

More NDCs from Long Grove Pharmaceuticals, LLC labeler code 81298

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 41 words ▾

1 INDICATIONS AND USAGE AK-FLUOR ® 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. AK-FLUOR is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The normal adult dose of AK-FLUOR ® 10% is 5 mL (500 mg) via intravenous administration. ( 2.1 ) For children, the dose should be calculated on the basis of 35 mg for each 4.54 kg of body weight. (7.7 mg/kg body weight) ( 2.1 ) Do not mix or dilute with other solutions or drugs. ( 2.2 )

2.1Dosing Adult Dose The recommended dosage of AK-FLUOR ® 10% (100 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 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, filled with AK-FLUOR ® , 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 of AK-FLUOR ® 10% may be appropriate in cases when a highly sensitive imaging system e.g., scanning laser ophthalmoscope is used.

💊 Dosage Forms and Strengths 91 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 10% (500 mg/ 5 mL) (100 mg/mL) of fluorescein sodium as a dark reddish orange, clear solution in a single-dose vial. 25% (500 mg/2 mL) (250 mg/mL) of fluorescein sodium as a dark reddish orange, clear solution in a single-dose vial (this strength is currently not being marketed). Injection ( 3 ): 10% (500 mg/5 mL) (100 mg/mL) of fluorescein sodium in a single-dose vial 25% (500 mg/2 mL) (250 mg/mL) of fluorescein sodium in a single-dose vial (this strength is currently not being marketed)

⛔ Contraindications 55 words ▾

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

4.1Hypersensitivity AK-FLUOR 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 Long Grove Pharmaceuticals, LLC at 1-855-642-2594 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 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.

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 to 530 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 yellowish 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 yellowish 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 essentially 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 to 530 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 yellowish 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 89 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING AK-FLUOR 10% (fluorescein injection) 500 mg/5 mL (100mg/mL) of fluorescein sodium is a dark reddish orange, clear solution in a single-dose vial. (NDC 81298-8660-3) 5 mL, single dose vials in a package of 12. AK-FLUOR (fluorescein injection) 25%, 500 mg/2 mL (250 mg/mL) of fluorescein sodium is a dark reddish orange, clear solution in a single-dose vial.

This strength is currently not being marketed. Store AK-FLUOR at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Do not freeze.

Discard unused portion.

📋 Description 158 words ▾

11 DESCRIPTION AK-FLUOR (fluorescein injection) contains fluorescein sodium, a diagnostic aid, in a sterile solution for use intravenously. It is a dark reddish orange clear solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt.

Its molecular weight is 376.27. The active ingredient is represented by the chemical structure: AK-FLUOR (500 mg/5 mL) (100 mg/mL) 10% contains: Active ingredient: fluorescein sodium (10 % w/v, 100 mg/mL), equivalent to 88.3 mg/ml of fluorescein Inactive ingredients: sodium hydroxide and/or hydrochloric acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR 25% (500 mg/2 mL) (250 mg/mL) contains (this strength is currently not being marketed): Active ingredient: fluorescein sodium (25% w/v, 250 mg/mL), equivalent to 220.8 mg/ml of fluorescein Inactive ingredients: 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 67 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 ( 6.1 ) ]. Rx only Manufactured for: Long Grove Pharmaceuticals, LLC Rosemont, IL 60018 Made in India Rev. 02/26

🍼 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 168 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 yellowish 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 essentially 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 83 words ▾

Principal Display Panel – 5 mL Carton Label NDC 81298- 8660 -3 Rx Only AK-FLUOR ® 10% Fluorescein Injection, USP 500 mg/5 mL (100 mg/mL) 12 Sterile Single-Dose Vials (5mL each) LONG GROVE™ PHARMACEUTICALS Principal Display Panel – 5 mL Carton Label

Principal Display Panel – 5 mL Vial Label NDC 81298- 8660 -1 Rx Only AK-FLUOR ® 10% Fluorescein Injection, USP 500 mg/5 mL (100 mg/mL) 5 mL Sterile Single-Dose Vial For Intravenous Injection 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) ✓ 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 Long Grove Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Long Grove 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.
← 81298-8554-03 · Long 81298-9655-03 · Long →
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.