NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1533Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1533Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
51662-1533-35166215330312 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from May 10, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Fluorescein
Generic name (nonproprietary)
fluorescein
Active ingredients
Fluorescein sodium — 100 mg/mL
Dosage form
Injection
Route
Intravenous
Labeler
HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022186
Marketing start
Listing expires
Other FDA classes
Dyes (Mechanism)
Identifiers
Product ID 51662-1533_c915cb71-f04b-2377-e053-2995a90a5d92SPL ID c915cb71-f04b-2377-e053-2995a90a5d92SPL set ID c1ffe119-7fba-940f-e053-2a95a90a7a17UNII 93X55PE38X
Pharmacologic class
Diagnostic Dye

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N451662153303 followed by a unit qualifier and the quantity

Package 51662-1533-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

1. INDICATIONS & USAGE AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51662-1533

What is NDC 51662-1533?
51662-1533 is the product NDC for Fluorescein, Fluorescein sodium 100 mg/mL injection, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fluorescein.
What is the active ingredient?
Fluorescein sodium.
Who is the labeler?
HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluorescein?
7 other product NDCs are listed under this name. See all Fluorescein NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluorescein NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FluoresceinFluorescein sodium 100 mg/mLInjectionIntravenousZydus Pharmaceuticals USA Inc.70710-204570710-2045-09
FluoresceinFluorescein sodium 250 mg/mLInjectionIntravenousZydus Pharmaceuticals USA Inc.70710-204670710-2046-09
FluoresceinFluorescein sodium 100 mg/mLInjectionIntravenousZydus Lifesciences Limited70771-196970771-1969-09
FluoresceinFluorescein sodium 250 mg/mLInjectionIntravenousZydus Lifesciences Limited70771-197070771-1970-09
FluoresceinFluorescein sodium 500 mg/5mLInjection, SolutionIntravenousBPI Labs LLC54288-17954288-0179-10
FluoresceinFluorescein 500 mg/mLInjectionIntravenousNexus Pharmaceuticals LLC14789-12214789-0122-05
FluoresceinFluorescein 250 mg/mLInjectionIntravenousNexus Pharmaceuticals LLC14789-12314789-0123-05

Other NDCs under NDA 022186

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022186
ProductStrengthForm · routeLabelerProduct NDC
Ak-FluorfluoresceinFluorescein sodium 100 mg/mLInjectionIntravenousLong Grove Pharmaceuticals, LLC81298-8660

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