What is NDC 67184-0569?

67184-0569 is the product NDC for Amikacin Sulfate, Amikacin sulfate 250 mg/mL injection, solution, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. 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 67184-0569 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67184-0569Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67184-0569Add 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
67184-0569-2	67184056902	10 VIAL, GLASS in 1 CARTON (67184-0569-2) / 2 mL in 1 VIAL, GLASS (67184-0569-1)Marketed from Mar 19, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Qilu Pharmaceutical Co., Ltd.NDC labeler code 67184
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218146
Marketing start: Mar 19, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 67184-0569_0a56f2df-a71f-44a1-b7d0-98ee44e30e80SPL ID 0a56f2df-a71f-44a1-b7d0-98ee44e30e80SPL set ID 20fa61ef-11e2-4d01-82ea-b5412cefaeadRxCUI 1723156, 1723160UNII N6M33094FDUPC 0367184057016, 0367184056910
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

N467184056902 followed by a unit qualifier and the quantity

Package 67184-0569-02. 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 Dec 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Amikacin Sulfate Injection 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-Enterobacter-Serratia species, and Acinetobacter ( Mima-Herellea ) species. Clinical studies have shown Amikacin Sulfate Injection to be effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67184-0569

What is NDC 67184-0569?: 67184-0569 is the product NDC for Amikacin Sulfate, Amikacin sulfate 250 mg/mL injection, solution, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, 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?: Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. 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.	67184-0570	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	Injection, SolutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-815	63323-0815-0263323-0815-04
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

Other NDCs under ANDA 218146

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

FDA NDC Directory listings under ANDA 218146
Product	Strength	Form · route	Labeler	Product NDC
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	Injection, SolutionIntramuscular, Intravenous	Qilu Pharmaceutical Co., Ltd.	67184-0570
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	InjectionIntramuscular, Intravenous	Mullan Pharmaceutical Inc.	83301-0022
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	InjectionIntramuscular, Intravenous	Mullan Pharmaceutical Inc.	83301-0023