Amikacin Sulfate NDC 0641-6167

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6167Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6167Add 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
0641-6167-10	00641616710	10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6167-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6167-01)Marketed from Aug 1, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Route: Intramuscular, Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 063315
Marketing start: Aug 1, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 0641-6167_36fb925f-8beb-4691-9136-500772c736faSPL ID 36fb925f-8beb-4691-9136-500772c736faSPL set ID 0b56f6df-a05d-4520-8bf0-d7cefe20f6adRxCUI 1723156, 1723160UNII N6M33094FD
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

N400641616710 followed by a unit qualifier and the quantity

Package 00641-6167-10. 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 Apr 8, 2024. 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)

Other NDCs under ANDA 063315

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

FDA NDC Directory listings under ANDA 063315
Product	Strength	Form · route	Labeler	Product NDC
Amikacin Sulfate	Amikacin sulfate 250 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6166