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 Directory
Product 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 NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
53329-603-09533290603091 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

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

N453329060309 followed by a unit qualifier and the quantity

Package 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?
47 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Medline NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MedlineacetaminophenAcetaminophen 325 mg/1TabletOralMedline Industries, LP53329-19953329-0199-09
MedlineacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMedline Industries, LP53329-22153329-0221-09
MedlineaspirinAspirin 81 mg/1Tablet, ChewableOralMedline Industries, LP53329-60153329-0601-09
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60553329-0605-09
Medlinemiconazole nitrateMiconazole nitrate 20 mg/gOintmentTopicalMedline Industries, LP53329-25653329-0256-1453329-0256-64
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60453329-0604-30
MedlinedimethiconeDimethicone 1.575 g/100mLCreamTopicalMedline Industries, LP53329-27153329-0271-4453329-0271-86
MedlineaspirinAspirin 81 mg/1Tablet, Delayed releaseOralMedline Industries, LP53329-60053329-0600-67
Medlinewhite petrolatumWhite petrolatum 86.5 g/100gOintmentTopicalMedline Industries, LP53329-25753329-0257-1053329-0257-74
Medlinezinc oxideZinc oxide 200 mg/gPasteTopicalMedline Industries, LP53329-25553329-0255-0553329-0255-10

All 48 Medline NDCs

Other NDCs under ANDA 072096

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 072096
ProductStrengthForm · routeLabelerProduct NDC
Good Sense IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralL. Perrigo Company0113-1212
Berkley and Jensen IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBJWC68391-604
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralKroger Company30142-604
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-604
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5223
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-647
betr pain reliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-604
betr remedies ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-999
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2068
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralHyVee Inc42507-399
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-604
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-604
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-647
Equate IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-553
Goodnow Pain ReliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralGobrands, Inc82501-0604
good sense ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7053
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-604
good sense ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralL. Perrigo Company0113-0647
care one ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-604
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralHyVee Inc42507-604

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Medline NDC 53329-603 | National Drug Code | Med-Code