Prescription drug · NDA
Akovaz (ephedrine sulfate) NDC 51754-4250
Ephedrine sulfate 5 mg/mL · Injection · Intravenous · Exela Pharma Sciences, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51754-4250-3 | 51754425003 | 10 SYRINGE, PLASTIC in 1 CARTON (51754-4250-3) / 5 mL in 1 SYRINGE, PLASTICMarketed from May 10, 2021 |
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)
- Akovaz
- Generic name (nonproprietary)
- ephedrine sulfate
- Active ingredients
- Ephedrine sulfate — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Exela Pharma Sciences, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208289
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Increased Norepinephrine Activity (Physiologic effect)
- Identifiers
- Product ID 51754-4250_5a627a89-7997-4af5-a1d0-2cedbe1bc868SPL ID 5a627a89-7997-4af5-a1d0-2cedbe1bc868SPL set ID e92f3eda-33eb-4b34-9e8b-db8d32a5dbd9RxCUI 1116294, 1796730, 2586841, 2586845UNII 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
N451754425003followed by a unit qualifier and the quantityPackage 51754-4250-03. 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)
AKOVAZ (ephedrine sulfate injection) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. AKOVAZ 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 NDA 208289
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 |
|---|---|---|---|---|
| Akovazephedrine sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | Exela Pharma Sciences, LLC | 51754-4200 |