Prescription drug · ANDA
Acetaminophen NDC 55150-307
Acetaminophen 10 mg/mL · Injection, Solution · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-307-24 | 5515003072455150030724 | 24 VIAL, SINGLE-DOSE in 1 CARTON (55150-307-24) / 100 mL in 1 VIAL, SINGLE-DOSE (55150-307-01)Marketed from Oct 21, 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
- Labeler
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210969
- Marketing start
- Listing expires
- Identifiers
- Product ID 55150-307_ddbd820d-6245-44a7-b539-3c6813ffa58aSPL ID ddbd820d-6245-44a7-b539-3c6813ffa58aSPL set ID f80b6f72-f280-4b4a-a6a9-e6490b94705bRxCUI 483017UNII 362O9ITL9DUPC 0355150307012
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
N455150030724followed by a unit qualifier and the quantityPackage 55150-0307-24. 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 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.
About NDC 55150-307
- What is NDC 55150-307?
- 55150-307 is the product NDC for Acetaminophen, Acetaminophen 10 mg/mL injection, solution, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen.
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Eugia US LLC, NDC labeler code 55150. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen?
- 234 other product NDCs are listed under this name. See all Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Yes: J0131, Injection, acetaminophen, 10 mg. See Billing references above.
Related NDCs: other Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| acetaminophen | Acetaminophen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4787 | 70518-4787-00 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4782 | 70518-4782-0070518-4782-01 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4783 | 70518-4783-00 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-099 | 72288-0099-79 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Amazon.com Services LLC | 72288-440 | 72288-0440-09 |
| acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Amazon.com Services LLC | 72288-150 | 72288-0150-79 |
| Acetaminophen | Acetaminophen 10 mg/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-871 | 70069-0871-10 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Walgreens | 0363-9810 | 00363-9810-1000363-9810-2500363-9810-50+1 more |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Family Dollar, Inc. | 55319-751 | 55319-0751-24 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | PUBLIX SUPERMARKETS, INC | 41415-175 | 41415-0175-0541415-0175-10 |
Other NDCs under ANDA 210969
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 | HF Acquisition Co LLC, DBA HealthFirst | 51662-1540 |
| Acetaminophen | Acetaminophen 10 mg/mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4184 |