Prescription drug · ANDA
Acetaminophen NDC 55579-405
Acetaminophen 10 mg/mL · Injection, Solution · Intravenous · Solupharm Pharmazeutische Erzeugnisse GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55579-405-24 | 55579040524 | 24 VIAL, GLASS in 1 CARTON (55579-405-24) / 100 mL in 1 VIAL, GLASSMarketed from Dec 7, 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)
- Acetaminophen
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202605
- Marketing start
- Listing expires
- Identifiers
- Product ID 55579-405_d92bd5a7-d41c-31d1-e053-2995a90a143aSPL ID d92bd5a7-d41c-31d1-e053-2995a90a143aSPL set ID d92be8ae-3173-0a9d-e053-2995a90abc63RxCUI 483017UNII 362O9ITL9D
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 codeMed-Code curated
J0131 — Injection, acetaminophen, 10 mg
Billing unit: 10 mg. Units on the claim = dose given ÷ 10 mg.
- 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
N455579040524followed by a unit qualifier and the quantityPackage 55579-0405-24. 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)
Acetaminophen injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older the reduction of fever in adult and pediatric patients. ACETAMINOPHEN injection for intravenous use is indicated for the Management of mild to moderate pain in adult and pediatric patients 2 years and older ( 1 ) Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older ( 1 ) Reduction of fever in adult and pediatric patients ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202605
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 |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 10 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 24201-100 |
| Acetaminophen | Acetaminophen 1000 mg/100mL | InjectionIntravenous | Solupharm Pharmazeutische Erzeugnisse GmbH | 55579-110 |
| Acetaminophen | Acetaminophen 10 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 24201-110 |