ephedrine sulfate NDC 65219-546

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-546Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0546Add 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
65219-546-05	65219054605	10 SYRINGE, PLASTIC in 1 CARTON (65219-546-05) / 5 mL in 1 SYRINGE, PLASTIC (65219-546-01)Marketed from Jul 7, 2025

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): ephedrine sulfate
Generic name (nonproprietary): ephedrine sulfate
Active ingredients: Ephedrine sulfate — 5 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218271
Marketing start: Jul 7, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Increased Norepinephrine Activity (Physiologic effect)
Identifiers: Product ID 65219-546_de95d79e-ae15-4056-a4e5-ac3380768cdbSPL ID de95d79e-ae15-4056-a4e5-ac3380768cdbSPL set ID c021fe1b-3ac3-4577-b780-f6a3070908a1RxCUI 2586841, 2631017UNII U6X61U5ZEG
Pharmacologic class: Norepinephrine Releasing Agent; alpha-Adrenergic Agonist; 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

N465219054605 followed by a unit qualifier and the quantity

Package 65219-0546-05. 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 Jun 17, 2025.

Indications (excerpt from the label)

Ephedrine Sulfate Injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Ephedrine Sulfate Injection is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218271

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

FDA NDC Directory listings under ANDA 218271
Product	Strength	Form · route	Labeler	Product NDC
ephedrine sulfate	Ephedrine sulfate 5 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-548