Over-the-counter drug · ANDA

ibuprofen childrens (Ibuprofen) NDC 0363-0897

Ibuprofen 100 mg/5mL · Suspension · Oral · Walgreen Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0897Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0897Add 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
0363-0897-2600363089726003630897261 BOTTLE in 1 CARTON (0363-0897-26) / 120 mL in 1 BOTTLEMarketed from Mar 11, 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 childrensSuffix: childrens
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 100 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Walgreen CompanyNDC labeler code 0363
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074937
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0363-0897_a0ff1a01-4914-42c9-b837-754885a75f7aSPL ID a0ff1a01-4914-42c9-b837-754885a75f7aSPL set ID f67612e8-38f3-4d1c-889b-57995a2f9f66RxCUI 197803UNII WK2XYI10QM

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

N400363089726 followed by a unit qualifier and the quantity

Package 00363-0897-26. 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 the common cold, flu, sore throat, headache and toothache • reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0363-0897

What is NDC 0363-0897?
0363-0897 is the product NDC for ibuprofen childrens (ibuprofen), Ibuprofen 100 mg/5mL suspension, 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 childrens (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 childrens?
12 other product NDCs are listed under this name. See all ibuprofen childrens 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 childrens NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ibuprofen ChildrensibuprofenIbuprofen 100 mg/5mLSuspensionOralKroger Company30142-66030142-0660-26
ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralCVS Pharmacy59779-66059779-0660-2659779-0660-34
Ibuprofen ChildrensibuprofenIbuprofen 100 mg/5mLSuspensionOralH E B37808-36337808-0363-26
ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralHyVee Inc42507-16642507-0166-18
Ibuprofen ChildrensibuprofenIbuprofen 100 mg/5mLSuspensionOralMajor Pharmaceuticals0904-557700904-5577-20
Ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralHyVee Inc42507-66042507-0660-26
Ibuprofen ChildrensibuprofenIbuprofen 100 mg/5mLSuspensionOralWalgreen Company0363-066000363-0660-26
ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-66041250-0660-26
ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralWalgreen Company0363-016600363-0166-2600363-0166-34
ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralRite Aid Corporation11822-089711822-0897-0411822-0897-08

All 13 ibuprofen childrens NDCs

Other NDCs under ANDA 074937

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

FDA NDC Directory listings under ANDA 074937
ProductStrengthForm · routeLabelerProduct NDC
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralRite Aid Corporation11822-1685
equaline ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralUnited Natural Foods, Inc. dba UNFI41163-897
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralNuCare Pharmaceuticals, Inc.68071-5290
Good Neighbor Pharmacy Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerisource Bergen24385-361
Good Neighbor Pharmacy Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerisource Bergen24385-372
Rexall IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralDolgencorp, LLC55910-685
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-660
Good Sense Ibuprofen ChildrensibuprofenIbuprofen 100 mg/5mLSuspensionOralL. Perrigo Company0113-0660
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralH E B37808-200
ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-660
IbuprofenIbuprofen 100 mg/5mLSuspensionOralMajor Pharmaceuticals0904-5309
Leader IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0262
Ibuprofen ChildrensibuprofenIbuprofen 100 mg/5mLSuspensionOralKroger Company30142-660
Leader Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0263
leader IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0264
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-685
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-685
good neighbor pharmacy ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerisource Bergen24385-905
ibuprofenIbuprofen 100 mg/5mLSuspensionOralNuCare Pharmaceuticals,Inc.68071-5315
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-510

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