What is NDC 63323-696?

63323-696 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.

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?

74 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Yes: J0171, Injection, adrenalin, epinephrine, 0.1 mg.

Epinephrine NDC 63323-696 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-696Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0696Add 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
63323-696-25	63323069625	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-696-25) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-696-02)Marketed from Nov 21, 2024

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, Intraocular, Intravenous, Subcutaneous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213708
Marketing start: Nov 21, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
Identifiers: Product ID 63323-696_88a60798-b160-482a-b8f8-c52de27af8dcSPL ID 88a60798-b160-482a-b8f8-c52de27af8dcSPL set ID a6afb9e8-1db9-480c-8d31-58c5c870ca49RxCUI 1660014UNII YKH834O4BHUPC 0363323696023
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

N463323069625 followed by a unit qualifier and the quantity

Package 63323-0696-25. 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 Jul 29, 2026.

Indications (excerpt from the label)

Epinephrine is a non-selective alpha and beta adrenergic agonist indicated: • To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. ( 1.1 ) • For emergency treatment of allergic reactions (Type 1), including anaphylaxis. ( 1.2 ) • For induction and maintenance of mydriasis during intraocular surgery. ( 1.3 ) 1.1 Hypotension associated with Septic Shock Epinephrine Injection USP, 1 mg/mL is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 1.2 Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to inse…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-696

What is NDC 63323-696?: 63323-696 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?: 74 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Gland Pharma Limited	68083-699	68083-0699-1068083-0699-25
Epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	HF Acquisition Co LLC, DBA HealthFirst	51662-1708	51662-1708-03
Epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0143-9476	00143-9476-25
epinephrine	Epinephrine 1 mg/mL	Injection, Solution, ConcentrateIntramuscular, Intravenous, Subcutaneous	Baxter Healthcare Corporation	43066-801	43066-0801-02
epinephrine	Epinephrine 1 mg/mL	Injection, Solution, ConcentrateIntramuscular, Intravenous, Subcutaneous	Baxter Healthcare Corporation	43066-803	43066-0803-25
epinephrine	Epinephrine bitartrate 16 ug/mL	Injection, SolutionIntravenous	Baxter Healthcare Corporation	0338-0006	00338-0006-20
epinephrine	Epinephrine .15 mg/.15mL	InjectionSubcutaneous	REMEDYREPACK INC.	70518-4573	70518-4573-00
epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	GLENMARK PHARMACEUTICALS INC., USA	68462-761	68462-0761-30
Epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Amneal Pharmaceuticals Private Limited	80830-1659	80830-1659-02
epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Amneal Pharmaceuticals LLC	70121-1660	70121-1660-02

All 75 Epinephrine NDCs

Other NDCs under ANDA 213708

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

FDA NDC Directory listings under ANDA 213708
Product	Strength	Form · route	Labeler	Product NDC
Epinephrine	Epinephrine 1 mg/mL	Injection, Solution, ConcentrateIntramuscular, Intraocular, Intravenous, Subcutaneous	REMEDYREPACK INC.	70518-4274