Over-the-counter drug · ANDA
Childrens Ibuprofen Oral Suspension (Ibuprofen) NDC 0121-0833
Ibuprofen 100 mg/5mL · Suspension · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0833-00 | 00121083300 | 10 TRAY in 1 CASE (0121-0833-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0833-05)Marketed from Aug 1, 2025 | |
| 0121-0833-40 | 00121083340 | 4 TRAY in 1 CASE (0121-0833-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0833-05)Marketed from Aug 1, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Childrens Ibuprofen Oral Suspension
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 100 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214789
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 0121-0833_70b3589f-fd88-4a73-b758-0d456422bd27SPL ID 70b3589f-fd88-4a73-b758-0d456422bd27SPL set ID c26cefe0-182a-4b03-baeb-b3eb2e0e2267RxCUI 197803UNII 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
N400121083300followed by a unit qualifier and the quantityPackage 00121-0833-00. 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 0121-0833
- What is NDC 0121-0833?
- 0121-0833 is the product NDC for Childrens Ibuprofen Oral Suspension, Ibuprofen 100 mg/5mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Ibuprofen Oral Suspension (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Ibuprofen Oral Suspension?
- 9 other product NDCs are listed under this name. See all Childrens Ibuprofen Oral Suspension NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Ibuprofen Oral Suspension products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 200 mg/10mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1666 | 00121-1666-0000121-1666-40 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Reliable 1 Laboratories LLC | 69618-078 | 69618-0078-54 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Chain Drug Marketing Association, Inc. | 63868-796 | 63868-0796-04 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | AptaPharma Inc. | 76281-119 | 76281-0119-24 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Marc Glassman, Inc. | 68998-320 | 68998-0320-24 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | DEMOULAS SUPERMARKETS INC. | 53942-119 | 53942-0119-24 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Discount Drug Mart | 53943-119 | 53943-0119-24 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Pharmaceutical Associates, Inc. | 0121-0914 | 00121-0914-00 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/10mL | SuspensionOral | Pharmaceutical Associates, Inc. | 0121-1828 | 00121-1828-00 |
Other NDCs under ANDA 214789
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 Ibuprofen Oral Suspensionibuprofen | Ibuprofen 200 mg/10mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1666 |