What is NDC 63323-401?

63323-401 is the product NDC for Aztreonam, Aztreonam 1 g/1 injection, powder, lyophilized, 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 Aztreonam?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Aztreonam NDC 63323-401 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-401Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0401Add 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
63323-401-20	63323040120	10 VIAL in 1 TRAY (63323-401-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-01)Marketed from Nov 5, 2009

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): Aztreonam
Generic name (nonproprietary): aztreonam
Active ingredients: Aztreonam — 1 g/1
Dosage form: Injection, Powder, Lyophilized, 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 065439
Marketing start: Nov 5, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Monobactams (Chemical structure)
Identifiers: Product ID 63323-401_b6926b10-085f-4255-b4f1-24572a7ef57aSPL ID b6926b10-085f-4255-b4f1-24572a7ef57aSPL set ID c6cf7e13-a04e-47e2-9cec-44a278ee6becRxCUI 1664981, 1664986UNII G2B4VE5GH8UPC 0363323401016, 0363323402013
Pharmacologic class: Monobactam 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 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

N463323040120 followed by a unit qualifier and the quantity

Package 63323-0401-20. 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 29, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection 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 in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-401

What is NDC 63323-401?: 63323-401 is the product NDC for Aztreonam, Aztreonam 1 g/1 injection, powder, lyophilized, 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?: Aztreonam.
What is the active ingredient?: Aztreonam.
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 Aztreonam?: 7 other product NDCs are listed under this name. See all Aztreonam NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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

Other Aztreonam NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Aztreonam	Aztreonam 1 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Hospira, Inc.	0409-0829	00409-0829-01
Aztreonam	Aztreonam 2 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Hospira, Inc.	0409-0830	00409-0830-01
Aztreonam	Aztreonam 2 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-402	63323-0402-20
Aztreonam	Aztreonam 2 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-402	63323-0402-30
Aztreonam	Aztreonam 2 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-402	63323-0402-24

Other NDCs under ANDA 065439

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

FDA NDC Directory listings under ANDA 065439
Product	Strength	Form · route	Labeler	Product NDC
Aztreonam	Aztreonam 2 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-402
Aztreonam	Aztreonam 2 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-402
Aztreonam	Aztreonam 2 g/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-402