Prescription drug · ANDA
Ephedrine sulfate NDC 84549-611
Ephedrine sulfate 50 mg/mL · Injection · Intravenous · ProPharma Distribution
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84549-611-25 | 84549061125 | 1 mL in 1 VIAL, SINGLE-DOSE (84549-611-25)Marketed from Aug 27, 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 — 50 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- ProPharma Distribution
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216129
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Increased Norepinephrine Activity (Physiologic effect)
- Identifiers
- Product ID 84549-611_3a38b027-e8ea-5d08-e063-6294a90a3b49SPL ID 3a38b027-e8ea-5d08-e063-6294a90a3b49SPL set ID 3843c820-f54b-5349-e063-6294a90a6b18RxCUI 1116294UNII 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.
- NDC on a medical claim
N484549061125followed by a unit qualifier and the quantityPackage 84549-0611-25. 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 .
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.
Other NDCs under ANDA 216129
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ephedrine sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | NorthStar RxLLC | 72603-203 |
| Ephedrine sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | Lifestar Pharma LLC | 70756-611 |
| Ephedrine sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7302 |