NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1568Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1568Add 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
51662-1568-3516621568035166215680310 POUCH in 1 CASE (51662-1568-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1568-2) / 5 mL in 1 VIAL, SINGLE-DOSE (51662-1568-1)Marketed from Jun 25, 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)
Venofer (Iron Sucrose)
Generic name (nonproprietary)
venofer (iron sucrose)
Active ingredients
Iron sucrose — 20 mg/mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021135
Marketing start
Listing expires
Other FDA classes
Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
Identifiers
Product ID 51662-1568_1677c959-a5e5-8d41-e063-6294a90a4ebeSPL ID 1677c959-a5e5-8d41-e063-6294a90a4ebeSPL set ID c59cb54c-bee5-96d6-e053-2995a90a767cRxCUI 1741267UNII FZ7NYF5N8L
Pharmacologic class
Parenteral Iron Replacement; Phosphate Binder

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 codeMed-Code curated

J1756 — Injection, iron sucrose, 1 mg

Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.

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

N451662156803 followed by a unit qualifier and the quantity

Package 51662-1568-03. 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)

Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51662-1568

What is NDC 51662-1568?
51662-1568 is the product NDC for Venofer (Iron Sucrose), Iron sucrose 20 mg/mL injection, solution, 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?
Venofer (Iron Sucrose).
What is the active ingredient?
Iron sucrose.
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 Venofer (Iron Sucrose)?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Yes: J1756, Injection, iron sucrose, 1 mg. See Billing references above.

Other NDCs under NDA 021135

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

FDA NDC Directory listings under NDA 021135
ProductStrengthForm · routeLabelerProduct NDC
Venoferiron sucroseIron sucrose 20 mg/mLInjection, SolutionIntravenousAmerican Regent, Inc.0517-2310
Venoferiron sucroseIron sucrose 20 mg/mLInjection, SolutionIntravenousAmerican Regent, Inc.0517-2325
Venoferiron sucroseIron sucrose 20 mg/mLInjection, SolutionIntravenousAmerican Regent, Inc.0517-2340
Venoferiron sucroseIron sucrose 20 mg/mLInjection, SolutionIntravenousFresenius Medical Care Holdings, Inc.49230-530
Venoferiron sucroseIron sucrose 20 mg/mLInjection, SolutionIntravenousFresenius Medical Care Holdings, Inc.49230-534

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