Prescription drug · BLA

Procrit (erythropoietin) NDC 59676-302

Epoetin 2000 [iU]/mL · Injection, Solution · Intravenous, Subcutaneous · Janssen Products, LP

NDC codes

FDA NDC Directory
Product NDC (as listed)59676-302Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59676-0302Add 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
59676-302-01596760302016 VIAL, SINGLE-DOSE in 1 CARTON (59676-302-01) / 1 mL in 1 VIAL, SINGLE-DOSE (59676-302-00)Marketed from Jun 1, 1989

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Procrit
Generic name (nonproprietary)
erythropoietin
Active ingredients
Epoetin — 2000 [iU]/mL
Dosage form
Injection, Solution
Route
Intravenous, Subcutaneous
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 103234
Marketing start
Listing expires
Other FDA classes
Erythropoietin (Chemical structure)Increased Erythroid Cell Production (Physiologic effect)
Identifiers
Product ID 59676-302_325d5d88-413d-28a2-e063-6394a90a3948SPL ID 325d5d88-413d-28a2-e063-6394a90a3948SPL set ID 0c721ba4-ae19-417f-aae1-221ed1a0866aRxCUI 205913, 205918, 205922, 205924, 212219, 213475, 239998, 239999, 240000, 240377, 241999, 242706, 1721684, 1721690UNII 64FS3BFH5W

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

N459676030201 followed by a unit qualifier and the quantity

Package 59676-0302-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

PROCRIT is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ). Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ). Limitations of Use PROCRIT has not been shown to improve quality of life, fatigue, or patient well-being ( 1.5 ). PROCRIT is not indicated for use: In pa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 103234

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

FDA NDC Directory listings under BLA 103234
ProductStrengthForm · routeLabelerProduct NDC
ProcriterythropoietinEpoetin 3000 [iU]/mLInjection, SolutionIntravenous, SubcutaneousJanssen Products, LP59676-303
ProcriterythropoietinEpoetin 4000 [iU]/mLInjection, SolutionIntravenous, SubcutaneousJanssen Products, LP59676-304
ProcriterythropoietinEpoetin 10000 [iU]/mLInjection, SolutionIntravenous, SubcutaneousJanssen Products, LP59676-310
ProcriterythropoietinEpoetin 40000 [iU]/mLInjection, SolutionIntravenous, SubcutaneousJanssen Products, LP59676-340
ProcriterythropoietinEpoetin 10000 [iU]/mLInjection, SolutionIntravenous, SubcutaneousJanssen Products, LP59676-312
ProcriterythropoietinEpoetin 20000 [iU]/mLInjection, SolutionIntravenous, SubcutaneousJanssen Products, LP59676-320
Epogenepoetin alfaEpoetin 2000 [iU]/mLSolutionIntravenous, SubcutaneousAmgen, Inc55513-126
Epogenepoetin alfaEpoetin 10000 [iU]/mLSolutionIntravenous, SubcutaneousAmgen, Inc55513-144
Epogenepoetin alfaEpoetin 4000 [iU]/mLSolutionIntravenous, SubcutaneousAmgen, Inc55513-148
Epogenepoetin alfaEpoetin 3000 [iU]/mLSolutionIntravenous, SubcutaneousAmgen, Inc55513-267
Epogenepoetin alfaEpoetin 10000 [iU]/mLSolutionIntravenous, SubcutaneousAmgen, Inc55513-283
Epogenepoetin alfaEpoetin 20000 [iU]/mLSolutionIntravenous, SubcutaneousAmgen, Inc55513-478

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Procrit (erythropoietin) NDC 59676-302 | Med-Code