What is NDC 0562-7805?

0562-7805 is the product NDC for RhoGAM Ultra-Filtered PLUS (human rho(d) immune globulin), Human rho(D) immune globulin 300 ug/1 injection, solution, listed with the FDA by Kedrion Biopharma Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

RhoGAM Ultra-Filtered PLUS (Human rho(D) immune globulin).

Kedrion Biopharma Inc, NDC labeler code 0562. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for RhoGAM Ultra-Filtered PLUS?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

RhoGAM Ultra-Filtered PLUS NDC 0562-7805

NDC codes

FDA NDC Directory

Product NDC (as listed)0562-7805Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00562-7805Add 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 NDC	11-digit (billing)	Package
0562-7805-01	0056278050100562780501	1 POUCH in 1 CARTON (0562-7805-01) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)Marketed from Mar 9, 2007
0562-7805-05	0056278050500562780505	5 POUCH in 1 CARTON (0562-7805-05) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)Marketed from Mar 9, 2007
0562-7805-25	0056278052500562780525	25 POUCH in 1 CARTON (0562-7805-25) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)Marketed from Mar 9, 2007

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): RhoGAM Ultra-Filtered PLUS
Generic name (nonproprietary): human rho(d) immune globulin
Active ingredients: Human rho(D) immune globulin — 300 ug/1
Dosage form: Injection, Solution
Route: Intramuscular
Labeler: Kedrion Biopharma IncNDC labeler code 0562
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 103777
Marketing start: Mar 9, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Endogenous Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
Identifiers: Product ID 0562-7805_7ccbaf67-ab6a-490a-9b63-598d75a7afcaSPL ID 7ccbaf67-ab6a-490a-9b63-598d75a7afca
Pharmacologic class: Human Immunoglobulin G

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

N400562780501 followed by a unit qualifier and the quantity

Package 00562-7805-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0562-7805

What is NDC 0562-7805?: 0562-7805 is the product NDC for RhoGAM Ultra-Filtered PLUS (human rho(d) immune globulin), Human rho(D) immune globulin 300 ug/1 injection, solution, listed with the FDA by Kedrion Biopharma Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: RhoGAM Ultra-Filtered PLUS (Human rho(D) immune globulin).
What is the active ingredient?: Human rho(D) immune globulin.
Who is the labeler?: Kedrion Biopharma Inc, NDC labeler code 0562. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for RhoGAM Ultra-Filtered PLUS?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

RhoGAM Ultra-Filtered PLUS (Human rho(d) immune globulin) NDC 0562-7805