Over-the-counter drug · ANDA
Dolex Children (Ibuprofen) NDC 55758-304
Ibuprofen 100 mg/100mL · Liquid · Oral · Pharmadel LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55758-304-04 | 5575803040455758030404 | 1 BOTTLE in 1 CARTON (55758-304-04) / 118 mL in 1 BOTTLEMarketed from Aug 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)
- Dolex Children
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 100 mg/100mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Pharmadel LLCNDC labeler code 55758
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210602
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 55758-304_ac3c264f-da36-a474-e053-2a95a90abdadSPL ID ac3c264f-da36-a474-e053-2a95a90abdadSPL set ID ac3c264f-da37-a474-e053-2a95a90abdadUNII WK2XYI10QM
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N455758030404followed by a unit qualifier and the quantityPackage 55758-0304-04. 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: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
Excerpt only. Read the full label for complete information.
About NDC 55758-304
- What is NDC 55758-304?
- 55758-304 is the product NDC for Dolex Children (ibuprofen), Ibuprofen 100 mg/100mL liquid, listed with the FDA by Pharmadel LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dolex Children (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Pharmadel LLC, NDC labeler code 55758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dolex Children?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 210602
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 |
|---|---|---|---|---|
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | American Health Packaging | 60687-743 |
| Childrens Ibuprofen Grapeibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | AptaPharma Inc. | 76281-126 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | DEMOULAS SUPERMARKETS INC. | 53942-119 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Discount Drug Mart | 53943-119 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Chain Drug Marketing Association, Inc. | 63868-796 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Marc Glassman, Inc. | 68998-320 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | AptaPharma Inc. | 76281-119 |
| Childrens Ibuprofen Oral Suspension Dye freeibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | AptaPharma Inc. | 76281-128 |
| Childrens Ibuprofen Oral Suspension Dye Freeibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | FSA Store Inc. (Caring Mill) | 81522-311 |
| Childrens Ibuprofen Oral Suspension Original Berry Flavoribuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Puro Pharma Inc. | 83474-002 |
| Childrens Ibuprofen Oral Suspension, Bubble Gumibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Best Choice | 63941-127 |
| Childrens Ibuprofen Oral Suspension, Dye Freeibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Best Choice | 63941-128 |
| Ibuprofen Oral | Ibuprofen 100 mg/5mL | SuspensionOral | A-S Medication Solutions | 50090-4129 |
| Ibuprofen Oral | Ibuprofen 100 mg/5mL | SuspensionOral | Bryant Ranch Prepack | 63629-8540 |
| Ibuprofen Oral | Ibuprofen 100 mg/5mL | SuspensionOral | Bryant Ranch Prepack | 63629-8851 |
| Ibuprofen Oral | Ibuprofen 100 mg/5mL | SuspensionOral | Bryant Ranch Prepack | 63629-8852 |
| Ibuprofen Oral | Ibuprofen 100 mg/5mL | SuspensionOral | Bryant Ranch Prepack | 63629-8853 |
| Ibuprofen Oral | Ibuprofen 100 mg/5mL | SuspensionOral | NuCare Pharmaceuticals,Inc. | 68071-1628 |
| Ibuprofen Oral | Ibuprofen 100 mg/5mL | SuspensionOral | Camber Consumer Care Inc | 69230-308 |
| Ibuprofen Oral | Ibuprofen 100 mg/5mL | SuspensionOral | Camber Consumer Care Inc | 69230-309 |
Showing 20 of 37.