What is NDC 63323-815?

63323-815 is the product NDC for Amikacin Sulfate, Amikacin sulfate 250 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, 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 Amikacin Sulfate?

10 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amikacin Sulfate NDC 63323-815 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-815Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0815Add 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
63323-815-02	6332308150263323081502	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21)Marketed from Dec 9, 2015
63323-815-04	6332308150463323081504	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-815-22)Marketed from Dec 9, 2015

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): Amikacin Sulfate
Generic name (nonproprietary): amikacin sulfate
Active ingredients: Amikacin sulfate — 250 mg/mL
Dosage form: Injection, 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 205604
Marketing start: Dec 9, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 63323-815_04612f35-e6fb-4937-bdfe-32105876c5b6SPL ID 04612f35-e6fb-4937-bdfe-32105876c5b6SPL set ID c0f57839-1c9b-49e5-8c7a-708e2d16495dRxCUI 1723156, 1723160UNII N6M33094FDUPC 0363323815226
Pharmacologic class: Aminoglycoside 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

N463323081502 followed by a unit qualifier and the quantity

Package 63323-0815-02. 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 May 31, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Amikacin sulfate injection, USP is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli , species of indole-positive and indole-negative Proteus , Providencia species, Klebsiella species, Enterobacter species, Serratia species, and Acinetobacter species. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amikacin and other antibacterial drugs, amikacin 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 av…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-815

What is NDC 63323-815?: 63323-815 is the product NDC for Amikacin Sulfate, Amikacin sulfate 250 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amikacin Sulfate.
What is the active ingredient?: Amikacin sulfate.
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 Amikacin Sulfate?: 10 other product NDCs are listed under this name. See all Amikacin Sulfate 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 Amikacin Sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	InjectionIntramuscular, Intravenous	Mullan Pharmaceutical Inc.	83301-0022	83301-0022-02
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	InjectionIntramuscular, Intravenous	Mullan Pharmaceutical Inc.	83301-0023	83301-0023-02
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	Injection, SolutionIntramuscular, Intravenous	Qilu Pharmaceutical Co., Ltd.	67184-0569	67184-0569-02
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	Injection, SolutionIntramuscular, Intravenous	Qilu Pharmaceutical Co., Ltd.	67184-0570	67184-0570-02
Amikacin Sulfate	Amikacin sulfate 500 mg/2mL	Injection, SolutionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-785	23155-0785-41
Amikacin Sulfate	Amikacin sulfate 1 g/4mL	Injection, SolutionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-786	23155-0786-41
amikacin sulfate	Amikacin sulfate 250 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-173	25021-0173-0225021-0173-04
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6166	00641-6166-10
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6167	00641-6167-10
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	Injection, SolutionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-290	23155-0290-4123155-0290-42