Over-the-counter drug · ANDA

equate ibuprofen (Ibuprofen) NDC 49035-521

Ibuprofen 100 mg/1 · Tablet, Chewable · Oral · Wal-Mart Stores Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)49035-521Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0521Add 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
49035-521-6249035052162490350521621 BOTTLE in 1 CARTON (49035-521-62) / 24 TABLET, CHEWABLE in 1 BOTTLEMarketed from Oct 25, 2011
49035-521-6749035052167490350521672 BOTTLE in 1 CARTON (49035-521-67) / 24 TABLET, CHEWABLE in 1 BOTTLEMarketed from Oct 25, 2011

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/1
Dosage form
Tablet, Chewable
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 076359
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 49035-521_e1ed3aec-11a3-4ef5-8631-4ef8ccb7a061SPL ID e1ed3aec-11a3-4ef5-8631-4ef8ccb7a061SPL set ID abef43bc-ee9b-4a9c-9cf9-36c323213909RxCUI 310963UNII 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

N449035052162 followed by a unit qualifier and the quantity

Package 49035-0521-62. 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: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49035-521

What is NDC 49035-521?
49035-521 is the product NDC for equate ibuprofen (ibuprofen), Ibuprofen 100 mg/1 tablet, chewable, 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/5mLSuspensionOralWal-Mart Stores Inc49035-89749035-0897-2649035-0897-34
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 076359

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

FDA NDC Directory listings under ANDA 076359
ProductStrengthForm · routeLabelerProduct NDC
Up and Up Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralTarget Corporation11673-741
childrens ibuprofen 100ibuprofenIbuprofen 100 mg/1Tablet, ChewableOralWalgreen Company0363-1461
Good Neighbor Pharmacy Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmerisource Bergen46122-617
good neighbor pharmacy childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmerisource Bergen46122-632
Leader IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralCardinal Health 110, LLC. dba Leader70000-0239
foster and thrive childrens ibuprofen ibibuprofenIbuprofen 100 mg/1Tablet, ChewableOralStrategic Sourcing Services LLC70677-1145
ibuprofenIbuprofen 100 mg/1Tablet, ChewableOralHyVee Inc42507-461
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmazon.com Services LLC72288-763
Childrens MotrinibuprofenIbuprofen 100 mg/1Tablet, ChewableOralKenvue Brands LLC50580-932
Childrens MotrinibuprofenIbuprofen 100 mg/1Tablet, ChewableOralKenvue Brands LLC50580-933
careone childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmerican Sales Company41520-740
Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralPublix Super Markets Inc56062-801
childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralCVS Pharmacy69842-706
childrens ibuprofen 100ibuprofenIbuprofen 100 mg/1Tablet, ChewableOralWalgreen Company0363-1521
Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralRite Aid Corporation11822-4461
signature care childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralSafeway21130-701
Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmazon.com Services LLC72288-320
childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralCVS Pharmacy69842-329
childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralMeijer Distribution Inc41250-331
Good Sense Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralL. Perrigo Company0113-7366

Showing 20 of 37.

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