What is NDC 0548-9090?

0548-9090 is the product NDC for Amphadase (hyaluronidase), Hyaluronidase 150 [USP'U]/mL injection, listed with the FDA by Amphastar Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Amphastar Pharmaceuticals, Inc., NDC labeler code 0548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amphadase?

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.

Amphadase NDC 0548-9090 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0548-9090Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00548-9090Add 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
0548-9090-10	00548909010	10 VIAL, SINGLE-DOSE in 1 CARTON (0548-9090-10) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 26, 2004

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): Amphadase
Generic name (nonproprietary): hyaluronidase
Active ingredients: Hyaluronidase — 150 [USP'U]/mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Amphastar Pharmaceuticals, Inc.NDC labeler code 0548
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 021665
Marketing start: Oct 26, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Glycoside Hydrolases (Chemical structure)
Identifiers: Product ID 0548-9090_188cabde-5b1f-4083-8b6c-5dcb85f728d2SPL ID 188cabde-5b1f-4083-8b6c-5dcb85f728d2SPL set ID 8396ea96-7cb5-4e26-87a4-90bca9c3c6ddRxCUI 238271, 542925UNII 8KOG53Z5EM
Pharmacologic class: Endoglycosidase

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

N400548909010 followed by a unit qualifier and the quantity

Package 00548-9090-10. 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 Feb 1, 2024.

Indications (excerpt from the label)

Amphadase ® is an endoglycosidase indicated as an adjuvant: • in subcutaneous fluid administration for achieving hydration ( 1.1 ) • to increase absorption and dispersion of other injected drugs ( 1.2 ) • in subcutaneous urography for improving resorption of radiopaque agents ( 1.3 ) 1.1 Subcutaneous Fluid Administration Amphadase ® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2 Dispersion and Absorption of Injected Drugs Amphadase ® is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. 1.3 Subcutaneous Urography Amphadase ® is indicated as an adjunct in subcutaneous urography for improving resorption of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0548-9090

What is NDC 0548-9090?: 0548-9090 is the product NDC for Amphadase (hyaluronidase), Hyaluronidase 150 [USP'U]/mL injection, listed with the FDA by Amphastar Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amphadase (Hyaluronidase).
What is the active ingredient?: Hyaluronidase.
Who is the labeler?: Amphastar Pharmaceuticals, Inc., NDC labeler code 0548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amphadase?: 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.

Amphadase (Hyaluronidase) NDC 0548-9090