Over-the-counter drug · ANDA

care one ibuprofen (Ibuprofen) NDC 41520-604

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

NDC codes

FDA NDC Directory
Product NDC (as listed)41520-604Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41520-0604Add 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
41520-604-7141520060471415200604711 BOTTLE in 1 CARTON (41520-604-71) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 13, 2004
41520-604-7841520060478415200604781 BOTTLE in 1 CARTON (41520-604-78) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 13, 2004
41520-604-854152006048541520060485250 TABLET, FILM COATED in 1 BOTTLE (41520-604-85)Marketed from Nov 30, 2017
41520-604-904152006049041520060490500 TABLET, FILM COATED in 1 BOTTLE (41520-604-90)Marketed from Apr 13, 2004
41520-604-9341520060493415200604931000 TABLET, FILM COATED in 1 BOTTLE (41520-604-93)Marketed from Nov 30, 2017

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)
care one ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
American Sales CompanyNDC labeler code 41520
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 072096
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 41520-604_ec4746b3-2707-40c5-bb70-58a42f46c249SPL ID ec4746b3-2707-40c5-bb70-58a42f46c249SPL set ID 006adf23-21ab-4a4e-aae9-c4e587777165RxCUI 310965UNII 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

N441520060471 followed by a unit qualifier and the quantity

Package 41520-0604-71. 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 • muscular aches • minor pain of arthritis • toothache • backache • the common cold • menstrual cramps • temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 41520-604

What is NDC 41520-604?
41520-604 is the product NDC for care one ibuprofen (ibuprofen), Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by American Sales Company. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
care one ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for care one ibuprofen?
2 other product NDCs are listed under this name. See all care one 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 care one ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
care one ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmerican Sales Company41520-25541520-0255-10
care one ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerican Sales Company41520-89741520-0897-26

Other NDCs under ANDA 072096

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

FDA NDC Directory listings under ANDA 072096
ProductStrengthForm · routeLabelerProduct NDC
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1911
Goodnow Pain ReliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralGobrands, Inc82501-0604
pain reliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMeijer, Inc.79481-3000
up and up ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralTarget Corporation11673-604
good sense ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7249
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-0604
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-647
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1132
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralHyVee Inc42507-399
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1136
MedlineiburprofenIbuprofen 200 mg/1Tablet, Film coatedOralMedline Industries, LP53329-603
Ibuprofen 250ibuprofenIbuprofen 200 mg/1Tablet, CoatedOralJHK Inc dba American Safety & First Aid73598-1104
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-604
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-080
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-647
Ibuprofen 100ibuprofenIbuprofen 200 mg/1Tablet, CoatedOralJHK Inc dba American Safety & First Aid73598-1102
careone ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-647
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5223
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-757
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-604

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