What is NDC 63323-346?

63323-346 is the product NDC for Ceftriaxone, Ceftriaxone sodium 1 g/1 injection, powder, for solution, 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 Ceftriaxone?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Yes: J0696, Injection, ceftriaxone sodium, per 250 mg.

Ceftriaxone NDC 63323-346 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-346Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0346Add 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
63323-346-10	6332303461063323034610	25 VIAL in 1 CARTON (63323-346-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-346-01)Marketed from Jun 20, 2011

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): Ceftriaxone
Generic name (nonproprietary): ceftriaxone
Active ingredients: Ceftriaxone sodium — 1 g/1
Dosage form: Injection, Powder, For solution
Route: Intramuscular, Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065329
Marketing start: Jun 20, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Cephalosporins (Chemical structure)
Identifiers: Product ID 63323-346_27777645-c5ae-4c89-abaf-ddb62dc7b859SPL ID 27777645-c5ae-4c89-abaf-ddb62dc7b859SPL set ID 7ea1db43-40fa-417b-8911-ae98092070a0RxCUI 1665005, 1665021, 1665046UNII 023Z5BR09KUPC 0363323346010, 0363323347017
Pharmacologic class: Cephalosporin Antibacterial

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

J0696 — Injection, ceftriaxone sodium, per 250 mg

Billing unit: 250 mg. Units on the claim = dose given ÷ 250 mg.

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

N463323034610 followed by a unit qualifier and the quantity

Package 63323-0346-10. 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 Sep 30, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Before instituting treatment with Ceftriaxone for Injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection, USP and other antibacterial drugs, Ceftriaxone for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-346

What is NDC 63323-346?: 63323-346 is the product NDC for Ceftriaxone, Ceftriaxone sodium 1 g/1 injection, powder, for solution, 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?: Ceftriaxone.
What is the active ingredient?: Ceftriaxone sodium.
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 Ceftriaxone?: 17 other product NDCs are listed under this name. See all Ceftriaxone NDCs.
Is there a related HCPCS / J-code?: Yes: J0696, Injection, ceftriaxone sodium, per 250 mg. See Billing references above.

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

Other Ceftriaxone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ceftriaxone	Ceftriaxone sodium 1 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Civica, Inc.	72572-061	72572-0061-25
Ceftriaxone	Ceftriaxone sodium 2 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Civica, Inc.	72572-062	72572-0062-25
Ceftriaxone	Ceftriaxone sodium 10 g/1	Injection, Powder, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9678	00143-9678-01
Ceftriaxoneceftriaxone sodium	Ceftriaxone sodium 100 g/1	Injection, Powder, For solutionIntravenous	Samson Medical Technologies, LLC	66288-6100	66288-6100-01
ceftriaxone	Ceftriaxone sodium 1 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-106	25021-0106-10
ceftriaxone	Ceftriaxone sodium 2 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-107	25021-0107-20
Ceftriaxone	Ceftriaxone sodium 500 mg/1	Injection, Powder, For solutionIntramuscular, Intravenous	WG Critical Care, LLC	44567-700	44567-0700-25
Ceftriaxone	Ceftriaxone sodium 1 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	WG Critical Care, LLC	44567-701	44567-0701-95
Ceftriaxone	Ceftriaxone sodium 2 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	WG Critical Care, LLC	44567-702	44567-0702-95
Ceftriaxone	Ceftriaxone sodium 10 g/1	Injection, Powder, For solutionIntravenous	WG Critical Care, LLC	44567-703	44567-0703-01

All 18 Ceftriaxone NDCs

Other NDCs under ANDA 065329

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

FDA NDC Directory listings under ANDA 065329
Product	Strength	Form · route	Labeler	Product NDC
ceftriaxone	Ceftriaxone sodium 1 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-106
ceftriaxone	Ceftriaxone sodium 2 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-107
Ceftriaxone	Ceftriaxone sodium 500 mg/1	Injection, Powder, For solutionIntramuscular, Intravenous	WG Critical Care, LLC	44567-700
Ceftriaxone	Ceftriaxone sodium 1 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	WG Critical Care, LLC	44567-701
Ceftriaxone	Ceftriaxone sodium 2 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	WG Critical Care, LLC	44567-702
Ceftriaxone	Ceftriaxone sodium 2 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Proficient Rx LP	71205-593