Over-the-counter drug · ANDA

Topcare Ibuprofen (ibuprofen) NDC 36800-255

Ibuprofen 50 mg/1.25mL · Suspension/ drops · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-255Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0255Add 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
36800-255-10368000255101 BOTTLE in 1 CARTON (36800-255-10) / 30 mL in 1 BOTTLEMarketed from Sep 10, 2004

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 — 50 mg/1.25mL
Dosage form
Suspension/ drops
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075217
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 36800-255_c10ff53b-f979-4be5-a5fd-2f66b893eabfSPL ID c10ff53b-f979-4be5-a5fd-2f66b893eabfSPL set ID 742f33fa-8923-4415-bcd6-8db37f2e1974RxCUI 204442UNII 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

N436800025510 followed by a unit qualifier and the quantity

Package 36800-0255-10. 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)

Other NDCs under ANDA 075217

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

FDA NDC Directory listings under ANDA 075217
ProductStrengthForm · routeLabelerProduct NDC
infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralWalgreen Company0363-8139
good neighbor pharmacy ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmerisource Bergen24385-550
Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralSafeway21130-513
parents choice infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralWal-Mart Stores Inc49035-601
Equaline IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralUnited Natural Foods, Inc. dba UNFI41163-057
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralRite Aid Corporation11822-0255
Dg Health IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralDolgencorp, LLC55910-503
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralCVS Pharmacy59779-313
ibuprofenIbuprofen 50 mg/1.25mLSuspensionOralMajor Pharmaceuticals0904-5463
basic care infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralAmazon.com Services LLC72288-057
profen ib infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralPublix Super Markets Inc56062-057
Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmazon.com Services LLC72288-770
Topcare Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralTopco Associates LLC36800-057
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralMeijer Distribution Inc41250-255
Good Sense Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralL. Perrigo Company0113-0040
equaline ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralUnited Natural Foods, Inc. dba UNFI41163-255
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralKroger Company30142-255
Foster and Thrive Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralStrategic Sourcing Services LLC70677-1144
basic care infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmazon.com Services LLC72288-255
Foster and Thrive IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralStrategic Sourcing Services LLC70677-1146

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