Ephedrine Sulfate NDC 68083-495

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-495Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0495Add 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
68083-495-25	68083049525	25 VIAL, SINGLE-DOSE in 1 CARTON (68083-495-25) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 25, 2022

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: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216146
Marketing start: Feb 25, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Increased Norepinephrine Activity (Physiologic effect)
Identifiers: Product ID 68083-495_0b79ab41-7c76-4459-8021-57b4364d7dcdSPL ID 0b79ab41-7c76-4459-8021-57b4364d7dcdSPL set ID 4a66e6c1-6d01-46fa-a2da-566fbf6e11a4RxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N468083049525 followed by a unit qualifier and the quantity

Package 68083-0495-25. 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 Mar 4, 2022.

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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216146

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

FDA NDC Directory listings under ANDA 216146
Product	Strength	Form · route	Labeler	Product NDC
Ephedrine Sulfate	Ephedrine sulfate 50 mg/mL	InjectionIntravenous	REMEDYREPACK INC.	70518-4433
Ephedrine Sulfate	Ephedrine sulfate 50 mg/mL	InjectionIntravenous	Somerset Therapeutics, LLC	70069-819