Over-the-counter drug · ANDA

equate ibuprofen (Ibuprofen) NDC 49035-897

Ibuprofen 100 mg/5mL · Suspension · Oral · Wal-Mart Stores Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)49035-897Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0897Add 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
49035-897-2649035089726490350897261 BOTTLE in 1 CARTON (49035-897-26) / 118 mL in 1 BOTTLEMarketed from Feb 2, 1999
49035-897-3449035089734490350897341 BOTTLE in 1 CARTON (49035-897-34) / 237 mL in 1 BOTTLEMarketed from Dec 16, 2010

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)
equate ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 100 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Wal-Mart Stores IncNDC labeler code 49035
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 49035-897_82073546-a148-4538-8f61-75aa4ac6df0aSPL ID 82073546-a148-4538-8f61-75aa4ac6df0aSPL set ID 2daee8c1-d05e-406b-af65-b81bbbaa244dRxCUI 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

N449035089726 followed by a unit qualifier and the quantity

Package 49035-0897-26. 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 49035-897

What is NDC 49035-897?
49035-897 is the product NDC for equate ibuprofen (ibuprofen), Ibuprofen 100 mg/5mL suspension, listed with the FDA by Wal-Mart Stores Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
equate ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Wal-Mart Stores Inc, NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for equate ibuprofen?
5 other product NDCs are listed under this name. See all equate ibuprofen 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 equate ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Equate IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-51749035-0517-78
Equate IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-55349035-0553-90
equate ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralWal-Mart Stores Inc49035-52149035-0521-6249035-0521-67
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-60449035-0604-0049035-0604-0549035-0604-58+4 more
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-64749035-0647-7849035-0647-82

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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