Prescription drug · ANDA
Ephedrine Sulfate NDC 70518-4433
Ephedrine sulfate 50 mg/mL · Injection · Intravenous · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4433-0 | 70518443300 | 10 VIAL in 1 CARTON (70518-4433-0) / 1 mL in 1 VIAL (70518-4433-1)Marketed from Aug 12, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216146
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Increased Norepinephrine Activity (Physiologic effect)
- Identifiers
- Product ID 70518-4433_5b34772a-ccd8-ccfe-e063-6294a90acecdSPL ID 5b34772a-ccd8-ccfe-e063-6294a90acecd
- 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
N470518443300followed by a unit qualifier and the quantityPackage 70518-4433-00. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 216146
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 | Somerset Therapeutics, LLC | 70069-819 |
| Ephedrine Sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-495 |