Over-the-counter drug · ANDA

Childrens Ibuprofen 100 Dye Free (Ibuprofen) NDC 0363-0806

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

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0806Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0806Add 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
0363-0806-26003630806261 BOTTLE in 1 CARTON (0363-0806-26) / 118 mL in 1 BOTTLEMarketed from Feb 24, 2014
0363-0806-34003630806342 BOTTLE in 1 CARTON (0363-0806-34) / 118 mL in 1 BOTTLEMarketed from Feb 24, 2014

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)
Childrens Ibuprofen 100 Dye FreeSuffix: Dye Free
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 0363-0806_62695561-e28b-418a-aacd-c27cf6587c0fSPL ID 62695561-e28b-418a-aacd-c27cf6587c0fSPL set ID 397c84f3-2ffc-41e8-aefb-cc0b46afc7e7RxCUI 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

N400363080626 followed by a unit qualifier and the quantity

Package 00363-0806-26. 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 0363-0806

What is NDC 0363-0806?
0363-0806 is the product NDC for Childrens Ibuprofen 100 Dye Free (ibuprofen), Ibuprofen 100 mg/5mL suspension, listed with the FDA by Walgreen Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens Ibuprofen 100 Dye Free (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 Childrens Ibuprofen 100 Dye Free?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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
IbuprofenIbuprofen 100 mg/5mLSuspensionOralMajor Pharmaceuticals0904-5309
ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralRite Aid Corporation11822-0897
ibuprofenIbuprofen 100 mg/5mLSuspensionOralNuCare Pharmaceuticals,Inc.68071-5315
equate ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralWal-Mart Stores Inc49035-897
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-419
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 107, LLC55154-1577
dg health childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralDolgencorp, LLC55910-102
Leader IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0262
ibuprofenIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-2341
Leader Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0263
leader IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0264
Equaline IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralUnited Natural Foods, Inc. dba UNFI41163-685
DG Health childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralDolgencorp, LLC55910-166
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralRite Aid Corporation11822-1685
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCVS Pharmacy59779-971
good sense ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralL. Perrigo Company0113-0897
Good Neighbor Pharmacy ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerisource Bergen24385-009
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPrecision Dose Inc.68094-494
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPrecision Dose Inc.68094-503
Dye Free Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPrecision Dose Inc.68094-600

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