What is NDC 63323-813?

63323-813 is the product NDC for Oxacillin, Oxacillin sodium 1 g/20mL 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 Oxacillin?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxacillin NDC 63323-813 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-813Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0813Add 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
63323-813-20	6332308132063323081320	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-813-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-813-01)Marketed from Nov 1, 2020

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): Oxacillin
Generic name (nonproprietary): oxacillin
Active ingredients: Oxacillin sodium — 1 g/20mL
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 206198
Marketing start: Nov 1, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Penicillins (Chemical structure)
Identifiers: Product ID 63323-813_c7907a70-1efa-46eb-b046-fcf043fdb413SPL ID c7907a70-1efa-46eb-b046-fcf043fdb413SPL set ID af2dccac-98c8-488f-a133-6374b3ca8dbaRxCUI 1743547, 1743549UNII G0V6C994Q5
Pharmacologic class: Penicillin-class 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

N463323081320 followed by a unit qualifier and the quantity

Package 63323-0813-20. 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 Jul 29, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY-Susceptibility Testing ). Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-813

What is NDC 63323-813?: 63323-813 is the product NDC for Oxacillin, Oxacillin sodium 1 g/20mL 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?: Oxacillin.
What is the active ingredient?: Oxacillin 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 Oxacillin?: 12 other product NDCs are listed under this name. See all Oxacillin 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 Oxacillin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxacillin	Oxacillin sodium 2 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Armas Pharmaceuticals Inc.	72485-409	72485-0409-10
oxacillin	Oxacillin sodium 1 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Onesource Specialty Pharma Limited	83270-306	83270-0306-10
oxacillin	Oxacillin sodium 2 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Onesource Specialty Pharma Limited	83270-307	83270-0307-10
Oxacillinoxacillin sodium	Oxacillin sodium 10 g/100mL	Injection, Powder, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-811	63323-0811-00
Oxacillin	Oxacillin sodium 2 g/20mL	Injection, Powder, For solutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-812	63323-0812-20
Oxacillin	Oxacillin sodium 10 g/100mL	Injection, Powder, For solutionIntravenous	Wockhardt USA LLC.	64679-700	64679-0700-03
Oxacillin	Oxacillin sodium 1 g/20mL	Injection, Powder, For solutionIntramuscular, Intravenous	Wockhardt USA LLC.	64679-698	64679-0698-01
Oxacillin	Oxacillin sodium 2 g/20mL	Injection, Powder, For solutionIntramuscular, Intravenous	Wockhardt USA LLC.	64679-699	64679-0699-01
Oxacillinoxacillin sodium	Oxacillin sodium 1 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Eugia US LLC	55150-127	55150-0127-15
Oxacillinoxacillin sodium	Oxacillin sodium 2 g/1	Injection, Powder, For solutionIntramuscular, Intravenous	Eugia US LLC	55150-128	55150-0128-24

All 13 Oxacillin NDCs

Other NDCs under ANDA 206198

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

FDA NDC Directory listings under ANDA 206198
Product	Strength	Form · route	Labeler	Product NDC
Oxacillin	Oxacillin sodium 2 g/20mL	Injection, Powder, For solutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-812