Over-the-counter drug · ANDA
Concentrated ibuprofen infants (Ibuprofen) NDC 53041-637
Ibuprofen 50 mg/1.25mL · Suspension/ drops · Oral · Guardian Drug Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53041-637-09 | 5304106370953041063709 | 1 BOTTLE in 1 CARTON (53041-637-09) / 30 mL in 1 BOTTLEMarketed from Oct 3, 2018 |
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)
- Concentrated ibuprofen infants
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 50 mg/1.25mL
- 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 210755
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 53041-637_d0465832-f323-4ecd-a285-33a8c15eb799SPL ID d0465832-f323-4ecd-a285-33a8c15eb799SPL set ID 3a32f0c7-c03e-4783-a429-08280993ddfbRxCUI 204442UNII 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
N453041063709followed by a unit qualifier and the quantityPackage 53041-0637-09. 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: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Excerpt only. Read the full label for complete information.
About NDC 53041-637
- What is NDC 53041-637?
- 53041-637 is the product NDC for Concentrated ibuprofen infants (ibuprofen), Ibuprofen 50 mg/1.25mL suspension/ drops, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Concentrated ibuprofen infants (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 Concentrated ibuprofen infants?
- 2 other product NDCs are listed under this name. See all Concentrated ibuprofen infants NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Concentrated ibuprofen infants products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Concentrated ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Chain Drug Marketing Association Inc. | 83324-005 | 83324-0005-30 |
| Concentrated ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Wal-Mart Stores, Inc. | 49035-635 | 49035-0635-09 |
Other NDCs under ANDA 210755
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 |
|---|---|---|---|---|
| Concentrated ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Wal-Mart Stores, Inc. | 49035-635 |
| Concentrated ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Chain Drug Marketing Association Inc. | 83324-005 |
| Ibuprofen infants Dropsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Harris Teeter, LLC | 69256-687 |
| Infants Ibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Family Dollar Services, Inc. | 55319-637 |