NDC codes

FDA NDC Directory
Product NDC (as listed)70385-2024Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70385-2024Add 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 NDC11-digit (billing)PackageCopy
70385-2024-2703852024022 VIAL in 1 PACKAGE (70385-2024-2) / 1 mL in 1 VIALMarketed from Jul 1, 2013

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)
Adrenalin Vials
Generic name (nonproprietary)
epinephrine
Active ingredients
Epinephrine — 1 mg/mL
Dosage form
Injection
Route
Intramuscular, Intravenous, Subcutaneous
Labeler
Sina Health IncNDC labeler code 70385
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 204200
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
Identifiers
Product ID 70385-2024_48355ef9-26fb-d460-e063-6294a90a0ef2SPL ID 48355ef9-26fb-d460-e063-6294a90a0ef2SPL set ID 28649937-8ae1-a022-e063-6394a90aebe0RxCUI 1660014, 1660016UNII YKH834O4BHUPC 0342023168016
Pharmacologic class
Catecholamine; 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 codeMed-Code curated

J0171 — Injection, adrenalin, epinephrine, 0.1 mg

Billing unit: 0.1 mg. Units on the claim = dose given ÷ 0.1 mg.

Applies when epinephrine is administered in a clinical setting. Auto-injectors dispensed to patients are billed by NDC through a pharmacy benefit.

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

N470385202402 followed by a unit qualifier and the quantity

Package 70385-2024-02. 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)

Adrenalin ® is a non-selective alpha and beta adrenergic agonist indicated for: Emergency treatment of allergic reactions (Type 1), including anaphylaxis ( 1.1 ) To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1.2 ) 1.1 Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. 1.2 Hypotension associated with Septic Shock Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70385-2024

What is NDC 70385-2024?
70385-2024 is the product NDC for Adrenalin Vials (epinephrine), Epinephrine 1 mg/mL injection, listed with the FDA by Sina Health Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Adrenalin Vials (Epinephrine).
What is the active ingredient?
Epinephrine.
Who is the labeler?
Sina Health Inc, NDC labeler code 70385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Adrenalin Vials?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Yes: J0171, Injection, adrenalin, epinephrine, 0.1 mg. See Billing references above.

Other NDCs under NDA 204200

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

FDA NDC Directory listings under NDA 204200
ProductStrengthForm · routeLabelerProduct NDC
Epinephrine Professionalepinephrine and isopropyl alcohol—KitIntramuscular, SubcutaneousFocus Health Group24357-011
Epinephrine Convenience Kitepinephrine—KitIntramuscular, SubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-1507
AdrenalinepinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousMedical Purchasing Solutions, LLC71872-7223
Adrenalin (Epinephrine)Epinephrine 1 mg/mLInjectionIntramuscular, SubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-1290
AdrenalinepinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousPar Health USA, LLC42023-159
AdrenalinepinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousProPharma Distribution84549-159
AdrenalinepineprineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHenry Schein, Inc.0404-9810

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