What is NDC 13533-631?

13533-631 is the product NDC for Hyperrho Full Dose (rho(d) immune globulin (human)), Human rho(D) immune globulin 1500 [iU]/mL solution, listed with the FDA by GRIFOLS USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Hyperrho Full Dose (Rho(D) immune globulin (Human)).

GRIFOLS USA, LLC, NDC labeler code 13533. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hyperrho Full Dose?

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.

Hyperrho Full Dose NDC 13533-631 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)13533-631Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13533-0631Add 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	Copy
13533-631-02	1353306310213533063102	1 SYRINGE in 1 CARTON (13533-631-02) / 1 mL in 1 SYRINGE (13533-631-20)Marketed from Aug 14, 1996
13533-631-11	1353306311113533063111	10 CARTON in 1 CARTON (13533-631-11) / 1 SYRINGE in 1 CARTON (13533-631-03) / 1 mL in 1 SYRINGE (13533-631-20)Marketed from Aug 14, 1996

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): Hyperrho Full DoseSuffix: FULL DOSE
Generic name (nonproprietary): rho(d) immune globulin (human)
Active ingredients: Human rho(D) immune globulin — 1500 [iU]/mL
Dosage form: Solution
Route: Intramuscular
Labeler: GRIFOLS USA, LLCNDC labeler code 13533
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 101141
Marketing start: Aug 14, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Endogenous Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
Identifiers: Product ID 13533-631_15eb46ca-9bb5-4d31-afb8-ba54f07d8f1eSPL ID 15eb46ca-9bb5-4d31-afb8-ba54f07d8f1e
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

N413533063102 followed by a unit qualifier and the quantity

Package 13533-0631-02. 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 13533-631

What is NDC 13533-631?: 13533-631 is the product NDC for Hyperrho Full Dose (rho(d) immune globulin (human)), Human rho(D) immune globulin 1500 [iU]/mL solution, listed with the FDA by GRIFOLS USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hyperrho Full Dose (Rho(D) immune globulin (Human)).
What is the active ingredient?: Human rho(D) immune globulin.
Who is the labeler?: GRIFOLS USA, LLC, NDC labeler code 13533. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hyperrho Full Dose?: 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.

Other NDCs under BLA 101141

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

FDA NDC Directory listings under BLA 101141
Product	Strength	Form · route	Labeler	Product NDC
Hyperrho Mini-Doserho(d) immune globulin (human)	Human rho(D) immune globulin 250 [iU]/mL	SolutionIntramuscular	GRIFOLS USA, LLC	13533-661

Hyperrho Full Dose (Rho(d) immune globulin (human)) NDC 13533-631