Prescription drug · ANDA
Amikacin Sulfate NDC 83301-0022
Amikacin sulfate 250 mg/mL · Injection · Intramuscular, Intravenous · Mullan Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83301-0022-2 | 83301002202 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83301-0022-2) / 2 mL in 1 VIAL, SINGLE-DOSE (83301-0022-1)Marketed from Jan 12, 2026 |
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
- Route
- Intramuscular, Intravenous
- Labeler
- Mullan Pharmaceutical Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218146
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 83301-0022_4849a73e-8a94-e5c8-e063-6294a90acab5SPL ID 4849a73e-8a94-e5c8-e063-6294a90acab5SPL set ID 840ba25a-d60c-4f0d-a084-71b0c68237dfRxCUI 1723156, 1723160UNII N6M33094FDUPC 0383301002226, 0383301002325
- 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.
- NDC on a medical claim
N483301002202followed by a unit qualifier and the quantityPackage 83301-0022-02. 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 . 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.
Other NDCs under ANDA 218146
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amikacin Sulfate | Amikacin sulfate 250 mg/mL | Injection, SolutionIntramuscular, Intravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0569 |
| Amikacin Sulfate | Amikacin sulfate 250 mg/mL | InjectionIntramuscular, Intravenous | Mullan Pharmaceutical Inc. | 83301-0023 |
| Amikacin Sulfate | Amikacin sulfate 250 mg/mL | Injection, SolutionIntramuscular, Intravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0570 |