Isoproterenol Hydrochloride NDC 0548-9501

NDC codes

FDA NDC Directory

Product NDC (as listed)0548-9501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00548-9501Add 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
0548-9501-00	00548950100	10 VIAL in 1 CARTON (0548-9501-00) / 1 mL in 1 VIALMarketed from Jun 18, 2018

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): Isoproterenol Hydrochloride
Generic name (nonproprietary): isoproterenol hydrochloride
Active ingredients: Isoproterenol hydrochloride — .2 mg/mL
Dosage form: Injection, Solution
Route: Intracardiac, Intramuscular, Intravenous, Subcutaneous
Labeler: Amphastar Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210106
Marketing start: Jun 18, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Agonists (Mechanism)
Identifiers: Product ID 0548-9501_45b3a44e-2743-4c38-be9d-f53595c41474SPL ID 45b3a44e-2743-4c38-be9d-f53595c41474SPL set ID 86b2455a-0489-405e-bd0b-9f79d3c5350dRxCUI 1667909, 1667915UNII DIA2A74855
Pharmacologic class: beta-Adrenergic Agonist

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

N400548950100 followed by a unit qualifier and the quantity

Package 00548-9501-00. 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 Oct 1, 2022.

Indications (excerpt from the label)

Isoproterenol Hydrochloride Injection, USP is indicated: • To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output • For bronchospasm occurring during anesthesia Isoproterenol Hydrochloride Injection, USP is a beta-adrenergic agonist indicated: • To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output ( 1 ) • For treatment of bronchospasm occurring during anesthesia ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210106

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

FDA NDC Directory listings under ANDA 210106
Product	Strength	Form · route	Labeler	Product NDC
Isoproterenol Hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntracardiac, Intramuscular, Intravenous, Subcutaneous	Amphastar Pharmaceuticals, Inc.	0548-9502