Over-the-counter drug · ANDA

Ibuprofen 200 (Ibuprofen) NDC 0363-0393

Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · Walgreen Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0393Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0393Add 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
0363-0393-200036303932000363039320225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0393-20)Marketed from Mar 1, 1999

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Ibuprofen 200
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Walgreen CompanyNDC labeler code 0363
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075139
Marketing start
Marketing end
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0363-0393_d6695f02-fda6-4dfa-a57f-19b50e264bcdSPL ID d6695f02-fda6-4dfa-a57f-19b50e264bcdSPL set ID 62e8db95-aaef-4b0e-841e-64a0339f3190RxCUI 310965UNII WK2XYI10QMUPC 0311917089812

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

N400363039320 followed by a unit qualifier and the quantity

Package 00363-0393-20. 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)

Uses temporarily relieves minor aches and pains due to: headache the common cold minor pain of arthritis backache menstrual cramps toothache muscular aches temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0363-0393

What is NDC 0363-0393?
0363-0393 is the product NDC for Ibuprofen 200 (ibuprofen), Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by Walgreen Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ibuprofen 200 (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ibuprofen 200?
2 other product NDCs are listed under this name. See all Ibuprofen 200 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 Ibuprofen 200 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ibuprofen 200ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-151700363-1517-78
Ibuprofen 200ibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralWALGREEN COMPANY0363-022200363-0222-22

Other NDCs under ANDA 075139

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

FDA NDC Directory listings under ANDA 075139
ProductStrengthForm · routeLabelerProduct NDC
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0669
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralTopco Associates, LLC36800-993
Dye Free IbuprofenibuprofenIbuprofen 200 mg/1TabletOralBreeden Brothers, LLC70729-002
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. DBA Leader70000-0291
Ibuprofen Dye-FreeibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-438
Ibuprofen Dye FreeibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWALMART INC.79903-415
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralH E B37808-393
pain relief ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralRite Aid Corporation11822-0392
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralRite Aid Corporation11822-0393
Dye Free IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-4381
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-993
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralARMY AND AIR FORCE EXCHANGE SERVICE55301-392
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7914
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCOSTCO WHOLESALE CORPORATION63981-393
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralARMY AND AIR FORCE EXCHANGE SERVICE55301-393
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMeijer Distribution, Inc.79481-0392
Dye Free IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-0438
Ibuprofen Dye FreeibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCVS Pharmacy59779-438
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralFamily Dollar Services Inc55319-893
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralL.N.K. International, Inc.50844-353

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