Prescription drug · ANDA
Ephedrine Sulfate NDC 16714-037
Ephedrine sulfate 50 mg/mL · Injection · Intravenous · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-037-10 | 1671400371016714003710 | 10 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-10) / 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01)Marketed from Dec 2, 2020 |
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
- NorthStar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212932
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Increased Norepinephrine Activity (Physiologic effect)
- Identifiers
- Product ID 16714-037_ab525532-8541-49b9-ba78-c39ebdc4c60dSPL ID ab525532-8541-49b9-ba78-c39ebdc4c60dSPL set ID 7b29542f-3a32-4113-bb1c-1fbd280046e2RxCUI 1116294UNII U6X61U5ZEGUPC 0316714037103, 0316714037257
- 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
N416714003710followed by a unit qualifier and the quantityPackage 16714-0037-10. 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.
About NDC 16714-037
- What is NDC 16714-037?
- 16714-037 is the product NDC for Ephedrine Sulfate, Ephedrine sulfate 50 mg/mL injection, listed with the FDA by NorthStar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ephedrine Sulfate.
- What is the active ingredient?
- Ephedrine sulfate.
- Who is the labeler?
- NorthStar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ephedrine Sulfate?
- 32 other product NDCs are listed under this name. See all Ephedrine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ephedrine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ephedrine sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-336 | 36000-0336-25 |
| Ephedrine Sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | REMEDYREPACK INC. | 70518-4433 | 70518-4433-00 |
| ephedrine sulfate | Ephedrine sulfate 5 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-546 | 65219-0546-05 |
| ephedrine sulfate | Ephedrine sulfate 5 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-548 | 65219-0548-10 |
| Ephedrine Sulfate | Ephedrine sulfate 5 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-610 | 68083-0610-10 |
| Ephedrine Sulfate | Ephedrine sulfate 5 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6236 | 00641-6236-10 |
| Ephedrine Sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | Somerset Therapeutics, LLC | 70069-819 | 70069-0819-10 |
| Ephedrine Sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | Caplin Steriles Limited | 65145-158 | 65145-0158-25 |
| Ephedrine sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | NorthStar RxLLC | 72603-203 | 72603-0203-1072603-0203-25 |
| Ephedrine Sulfate | Ephedrine sulfate 5 mg/mL | InjectionIntravenous | Par Health USA, LLC | 42023-243 | 42023-0243-99 |
Other NDCs under ANDA 212932
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 | Amneal Pharmaceuticals LLC | 70121-1637 |
| Ephedrine Sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7257 |
| Ephedrine Sulfate | Ephedrine sulfate 50 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7269 |