Over-the-counter drug · ANDA

Topcare Ibuprofen (Ibuprofen) NDC 36800-647

Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-647Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0647Add 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
36800-647-62368000647621 BOTTLE in 1 CARTON (36800-647-62) / 24 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 28, 2006
36800-647-71368000647711 BOTTLE in 1 CARTON (36800-647-71) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Nov 15, 1988
36800-647-78368000647781 BOTTLE in 1 CARTON (36800-647-78) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 2, 1991
36800-647-9036800064790500 TABLET, FILM COATED in 1 BOTTLE (36800-647-90)Marketed from Nov 20, 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)
Topcare Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Topco Associates LLCNDC labeler code 36800
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 36800-647_02993180-71f3-4807-bc0d-45d10238c7a8SPL ID 02993180-71f3-4807-bc0d-45d10238c7a8SPL set ID 8be375b0-c729-49de-abc5-2e7d37144b89RxCUI 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

N436800064762 followed by a unit qualifier and the quantity

Package 36800-0647-62. 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 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 36800-647

What is NDC 36800-647?
36800-647 is the product NDC for Topcare Ibuprofen (ibuprofen), Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by Topco Associates LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Topcare Ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Topcare Ibuprofen?
3 other product NDCs are listed under this name. See all Topcare 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 Topcare Ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Topcare ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralTopco Associates LLC36800-51736800-0517-7136800-0517-78
Topcare IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralTopco Associates LLC36800-25536800-0255-10
TopCare IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralTopco Associates LLC36800-60436800-0604-6236800-0604-7136800-0604-76+4 more

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
good sense ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2047
good sense ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralL. Perrigo Company0113-0647
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5223
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-604
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2068
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralKroger Company30142-604
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-647
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-604
betr remedies ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-999
betr pain reliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-604
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralHyVee Inc42507-399
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6747
Equate IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-553
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-0604
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-604
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralProficient Rx LP71205-357
Ibuprofen 250ibuprofenIbuprofen 200 mg/1Tablet, CoatedOralJHK Inc dba American Safety & First Aid73598-1104
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-647
Ibuprofen 100ibuprofenIbuprofen 200 mg/1Tablet, CoatedOralJHK Inc dba American Safety & First Aid73598-1102
Goodnow Pain ReliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralGobrands, Inc82501-0604

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