Over-the-counter drug · ANDA
Childrens Ibuprofen 572 (Ibuprofen) NDC 55319-929
Ibuprofen 100 mg/5mL · Suspension/ drops · Oral · Family Dollar Services, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55319-929-03 | 5531909290355319092903 | 1 BOTTLE in 1 CARTON (55319-929-03) / 120 mL in 1 BOTTLEMarketed from Apr 18, 2024 |
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)
- Childrens Ibuprofen 572
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 100 mg/5mL
- Dosage form
- Suspension/ drops
- Route
- Oral
- Labeler
- Family Dollar Services, Inc.NDC labeler code 55319
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210149
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 55319-929_3da7e78b-2397-42c5-8a9e-1dc9ae0afea4SPL ID 3da7e78b-2397-42c5-8a9e-1dc9ae0afea4SPL set ID 1a2182df-4339-442d-9c61-98c8b01e36faRxCUI 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
N455319092903followed by a unit qualifier and the quantityPackage 55319-0929-03. 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)
USE(S) 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 55319-929
- What is NDC 55319-929?
- 55319-929 is the product NDC for Childrens Ibuprofen 572 (ibuprofen), Ibuprofen 100 mg/5mL suspension/ drops, listed with the FDA by Family Dollar Services, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Ibuprofen 572 (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Family Dollar Services, Inc., NDC labeler code 55319. 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 572?
- 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 210149
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 | Suspension/ dropsOral | Guardian Drug Company | 53041-634 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Discount Drug Mart, Inc | 53943-682 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Family Dollar Services, Inc. | 55319-114 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Harris Teeter, LLC | 69256-634 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Chain Drug Marketing Association Inc. | 83324-012 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Chain Drug Marketing Association Inc. | 83324-013 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Chain Drug Marketing Association Inc. | 83324-014 |
| Childrens Ibuprofen blue raspberryibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Guardian Drug Company | 53041-638 |
| Childrens Ibuprofen bubblegumibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Guardian Drug Company | 53041-572 |
| Childrens Ibuprofen Bubblegum Dye Freeibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | CVS | 51316-932 |
| Childrens Ibuprofen fruitibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Guardian Drug Company | 53041-632 |
| Childrens Ibuprofen grapeibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Guardian Drug Company | 53041-639 |
| Dye Free Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | CVS | 51316-914 |