NDC codes

FDA NDC Directory
Product NDC (as listed)63323-698Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63323-0698Add 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
63323-698-3063323069830633230698301 VIAL, MULTI-DOSE in 1 CARTON (63323-698-30) / 30 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 13, 2025

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)
Epinephrine
Generic name (nonproprietary)
epinephrine
Active ingredients
Epinephrine — 1 mg/mL
Dosage form
Injection, Solution, Concentrate
Route
Intramuscular, Intravenous, Subcutaneous
Labeler
Fresenius Kabi USA, LLCNDC labeler code 63323
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 215425
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
Identifiers
Product ID 63323-698_b5fda38c-bff1-4c35-81cd-ea1c6cc39700SPL ID b5fda38c-bff1-4c35-81cd-ea1c6cc39700SPL set ID 4f83895f-638c-4515-af03-7c41ae60a42eRxCUI 310132UNII YKH834O4BHUPC 0363323698300
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

N463323069830 followed by a unit qualifier and the quantity

Package 63323-0698-30. 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)

Epinephrine is a non-selective alpha and beta adrenergic agonist indicated: • For emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients. ( 1.1 ) • To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. ( 1.2 ) 1.1 Anaphylaxis Epinephrine Injection is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adults and pediatric patients. 1.2 Hypotension associated with Septic Shock Epinephrine Injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-698

What is NDC 63323-698?
63323-698 is the product NDC for Epinephrine, Epinephrine 1 mg/mL injection, solution, concentrate, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Epinephrine.
What is the active ingredient?
Epinephrine.
Who is the labeler?
Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Epinephrine?
75 other product NDCs are listed under this name. See all Epinephrine NDCs.
Is there a related HCPCS / J-code?
Yes: J0171, Injection, adrenalin, epinephrine, 0.1 mg. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Epinephrine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
epinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousGland Pharma Limited68083-69968083-0699-1068083-0699-25
EpinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0143-947600143-9476-25
EpinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-170851662-1708-03
epinephrineEpinephrine 1 mg/mLInjection, Solution, ConcentrateIntramuscular, Intravenous, SubcutaneousBaxter Healthcare Corporation43066-80143066-0801-02
epinephrineEpinephrine 1 mg/mLInjection, Solution, ConcentrateIntramuscular, Intravenous, SubcutaneousBaxter Healthcare Corporation43066-80343066-0803-25
epinephrineEpinephrine bitartrate 16 ug/mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-000600338-0006-20
epinephrineEpinephrine .15 mg/.15mLInjectionSubcutaneousREMEDYREPACK INC.70518-457370518-4573-00
epinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousGLENMARK PHARMACEUTICALS INC., USA68462-76168462-0761-30
EpinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousAmneal Pharmaceuticals Private Limited80830-165980830-1659-02
epinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousAmneal Pharmaceuticals LLC70121-166070121-1660-02

All 76 Epinephrine NDCs

Other NDCs under NDA 215425

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

FDA NDC Directory listings under NDA 215425
ProductStrengthForm · routeLabelerProduct NDC
EpinephrineEpinephrine 1 mg/mLInjection, Solution, ConcentrateIntramuscular, Intravenous, SubcutaneousCIVICA, INC.72572-238

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