Over-the-counter drug · ANDA
Medline (Iburprofen) NDC 53329-603
Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · Medline Industries, LP
NDC codes
FDA NDC DirectoryProduct NDC (as listed)53329-603Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53329-0603Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-603-09 | 5332906030953329060309 | 1 BOTTLE in 1 BOX (53329-603-09) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 28, 2026 |
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)
- Medline
- Generic name (nonproprietary)
- iburprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Medline Industries, LPNDC labeler code 53329
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072096
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 53329-603_59e51e61-9078-e3ba-e063-6294a90a5c2bSPL ID 59e51e61-9078-e3ba-e063-6294a90a5c2b
- 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
N453329060309followed by a unit qualifier and the quantityPackage 53329-0603-09. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 53329-603
- What is NDC 53329-603?
- 53329-603 is the product NDC for Medline (iburprofen), Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by Medline Industries, LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Medline (Iburprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Medline?
- 46 other product NDCs are listed under this name. See all Medline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Medline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Medlineacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Medline Industries, LP | 53329-199 | 53329-0199-09 |
| Medlineacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Medline Industries, LP | 53329-221 | 53329-0221-09 |
| Medlineacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Medline Industries, LP | 53329-605 | 53329-0605-09 |
| Medlinemiconazole nitrate | Miconazole nitrate 20 mg/g | OintmentTopical | Medline Industries, LP | 53329-256 | 53329-0256-1453329-0256-64 |
| Medlineacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Medline Industries, LP | 53329-604 | 53329-0604-30 |
| Medlinedimethicone | Dimethicone 1.575 g/100mL | CreamTopical | Medline Industries, LP | 53329-271 | 53329-0271-4453329-0271-86 |
| Medlineaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Medline Industries, LP | 53329-600 | 53329-0600-67 |
| Medlinewhite petrolatum | White petrolatum 86.5 g/100g | OintmentTopical | Medline Industries, LP | 53329-257 | 53329-0257-1053329-0257-74 |
| Medlinezinc oxide | Zinc oxide 200 mg/g | PasteTopical | Medline Industries, LP | 53329-255 | 53329-0255-0553329-0255-10 |
| Medlinedimethicone | Dimethicone 2 g/100mL | LotionTopical | Medline Industries, LP | 53329-251 | 53329-0251-18 |
Other NDCs under ANDA 072096
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 |
|---|---|---|---|---|
| up and up ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-604 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-043 |
| Topcare Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-647 |
| good sense ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0647 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-6604 |
| Berkley and Jensen Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | BJWC | 68391-604 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-787 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-0604 |
| basic care ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-311 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6747 |
| Signature Care Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Safeway | 21130-818 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | H E B | 37808-647 |
| equaline ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-604 |
| kirkland signature ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Costco Wholesale Company | 63981-604 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-191 |
| equaline ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-647 |
| good sense ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2047 |
| good sense ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8590 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7912 |
| Good neighbor pharmacy ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 46122-548 |
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