Over-the-counter drug · OTC MONOGRAPH DRUG
topcare infants pain and fever (Acetaminophen) NDC 36800-590
Acetaminophen 160 mg/5mL · Suspension · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-590-16 | 36800059016 | 1 BOTTLE in 1 CARTON (36800-590-16) / 59 mL in 1 BOTTLEMarketed from Nov 3, 2011 |
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)
- topcare infants pain and fever
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 160 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-590_05990a16-479c-4ab1-8337-945eeb172fd4SPL ID 05990a16-479c-4ab1-8337-945eeb172fd4SPL set ID f129bc0e-1ef1-42a8-8668-2ee88ffc85e3RxCUI 307668UNII 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 codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N436800059016followed by a unit qualifier and the quantityPackage 36800-0590-16. 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 .
Indications (excerpt from the label)
Uses temporarily : • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
Excerpt only. Read the full label for complete information.
About NDC 36800-590
- What is NDC 36800-590?
- 36800-590 is the product NDC for topcare infants pain and fever (acetaminophen), Acetaminophen 160 mg/5mL suspension, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topcare infants pain and fever (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for topcare infants pain and fever?
- 2 other product NDCs are listed under this name. See all topcare infants pain and fever NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other topcare infants pain and fever products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| topcare infants pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Topco Associates LLC | 36800-766 | 36800-0766-16 |
| topcare infants pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Topco Associates LLC | 36800-946 | 36800-0946-1036800-0946-16 |
Other NDCs under M 013
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 |
|---|---|---|---|---|
| 365 whole foods market acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Whole Foods Market, INC. | 42681-0025 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0657 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0941 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1047 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1314 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1882 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1971 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-2094 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-2823 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-3141 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREENS | 0363-9538 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREEN CO. | 0363-9595 |
| Acetaminophen | Acetaminophen 160 mg/1 | TabletOral | WALGREEN CO. | 0363-9605 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREEN CO. | 0363-9798 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Walgreens | 0363-9810 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Rugby Laboratories | 0536-1172 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Rugby Laboratories | 0536-1292 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Rugby Laboratories | 0536-1413 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8608 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8609 |
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