Over-the-counter drug · ANDA

TopCare Ibuprofen (Ibuprofen) NDC 36800-604

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

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-604Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0604Add 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
36800-604-6236800060462368000604621 BOTTLE in 1 CARTON (36800-604-62) / 24 TABLET, FILM COATED in 1 BOTTLEMarketed from Jun 15, 1991
36800-604-7136800060471368000604711 BOTTLE in 1 CARTON (36800-604-71) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 15, 1988
36800-604-7636800060476368000604761 BOTTLE in 1 CARTON (36800-604-76) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 27, 1993
36800-604-7836800060478368000604781 BOTTLE in 1 CARTON (36800-604-78) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 15, 1988
36800-604-8236800060482368000604822 BOTTLE in 1 CARTON (36800-604-82) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 15, 1988
36800-604-8536800060485368000604851 BOTTLE in 1 CARTON (36800-604-85) / 250 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 30, 1991
36800-604-903680006049036800060490500 TABLET, FILM COATED in 1 BOTTLE (36800-604-90)Marketed from Jul 29, 1993

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 36800-604_7b44c9b1-8c1d-4234-922c-9ffff0202bc5SPL ID 7b44c9b1-8c1d-4234-922c-9ffff0202bc5SPL set ID 66097f19-227c-4f9c-a7f3-ab8476e1bb6eRxCUI 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

N436800060462 followed by a unit qualifier and the quantity

Package 36800-0604-62. 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 36800-604

What is NDC 36800-604?
36800-604 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 7 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 LLC36800-64736800-0647-6236800-0647-7136800-0647-78+1 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
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
care one ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-604
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

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