Over-the-counter drug · ANDA
Childrens Ibuprofen grape (Ibuprofen) NDC 53041-639
Ibuprofen 100 mg/5mL · Suspension/ drops · Oral · Guardian Drug Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53041-639-03 | 5304106390353041063903 | 1 BOTTLE in 1 CARTON (53041-639-03) / 120 mL in 1 BOTTLEMarketed from Oct 13, 2021 | |
| 53041-639-04 | 5304106390453041063904 | 1 BOTTLE in 1 CARTON (53041-639-04) / 240 mL in 1 BOTTLEMarketed from Oct 13, 2021 |
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 grape
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 100 mg/5mL
- Dosage form
- Suspension/ drops
- Route
- Oral
- Labeler
- Guardian Drug CompanyNDC labeler code 53041
- 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 53041-639_e690a788-b856-44b3-afff-bb950d1eb117SPL ID e690a788-b856-44b3-afff-bb950d1eb117SPL set ID 9cb92af9-a829-4f54-b8f5-4e5cb4f165b7RxCUI 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
N453041063903followed by a unit qualifier and the quantityPackage 53041-0639-03. 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 53041-639
- What is NDC 53041-639?
- 53041-639 is the product NDC for Childrens Ibuprofen grape (ibuprofen), Ibuprofen 100 mg/5mL suspension/ drops, listed with the FDA by Guardian Drug Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Ibuprofen grape (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Guardian Drug Company, NDC labeler code 53041. 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 grape?
- 1 other product NDC are listed under this name. See all Childrens Ibuprofen grape 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 grape 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 Grapeibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | AptaPharma Inc. | 76281-126 | 76281-0126-24 |
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 572ibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Family Dollar Services, Inc. | 55319-929 |
| 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 |
| Dye Free Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | CVS | 51316-914 |