Over-the-counter drug · ANDA

kirkland signature ibuprofen (Ibuprofen) NDC 63981-604

Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · Costco Wholesale Company

NDC codes

FDA NDC Directory
Product NDC (as listed)63981-604Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63981-0604Add 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
63981-604-906398106049063981060490500 TABLET, FILM COATED in 1 BOTTLE (63981-604-90)Marketed from Jun 25, 2003

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)
kirkland signature ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Costco Wholesale CompanyNDC labeler code 63981
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 63981-604_58d8bea2-6399-4004-81f0-9e64891b57deSPL ID 58d8bea2-6399-4004-81f0-9e64891b57deSPL set ID 65d8d650-9afc-44f7-9409-a3aa3014d4abRxCUI 310965UNII WK2XYI10QMUPC 0096619355402

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

N463981060490 followed by a unit qualifier and the quantity

Package 63981-0604-90. 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 63981-604

What is NDC 63981-604?
63981-604 is the product NDC for kirkland signature ibuprofen (ibuprofen), Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by Costco Wholesale Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
kirkland signature ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Costco Wholesale Company, NDC labeler code 63981. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for kirkland signature ibuprofen?
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 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
365 whole foods market ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWhole Foods Market, INC.42681-0026
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-311
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-604
Berkley and Jensen IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBJWC68391-604
betr pain reliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-604
betr remedies ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-999
care one ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-604
careone ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-647
CounterAct IBibuprofenIbuprofen 200 mg/1Tablet, CoatedOralMelaleuca, Inc54473-306
dg health ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDolgencorp, LLC55910-604
dg health ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDolgencorp Inc55910-647
equaline ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-604
equaline ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-647
Equate IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-553
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-604
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-647
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1132
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1136
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-604
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-647

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