Over-the-counter drug · ANDA

Topcare Infants Ibuprofen (Ibuprofen) NDC 36800-057

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

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-057Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0057Add 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
36800-057-0536800005705368000057051 BOTTLE in 1 CARTON (36800-057-05) / 15 mL in 1 BOTTLEMarketed from Jan 22, 2002

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 Infants Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 50 mg/1.25mL
Dosage form
Suspension
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 075217
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 36800-057_f581be63-9628-433f-8a31-eba6f530254eSPL ID f581be63-9628-433f-8a31-eba6f530254eSPL set ID 00d33273-e8c7-4d40-8e6f-a980f746fff2RxCUI 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

N436800005705 followed by a unit qualifier and the quantity

Package 36800-0057-05. 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)

About NDC 36800-057

What is NDC 36800-057?
36800-057 is the product NDC for Topcare Infants Ibuprofen (ibuprofen), Ibuprofen 50 mg/1.25mL suspension, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Topcare Infants 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 Infants 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 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
equaline ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralUnited Natural Foods, Inc. dba UNFI41163-255
basic care infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmazon.com Services LLC72288-255
up and up dye free infants concentrated ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralTarget Corporation11673-255
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralKroger Company30142-255
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralCVS Pharmacy59779-313
ibuprofen infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralH E B37808-057
Dg Health IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralDolgencorp, LLC55910-503
ibuprofen infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralHyVee Inc42507-057
Topcare IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralTopco Associates LLC36800-255
profen ib infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralPublix Super Markets Inc56062-057
infants dye free ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralKroger Company30142-497
ibuprofenIbuprofen 50 mg/1.25mLSuspensionOralMajor Pharmaceuticals0904-5463
Good Sense Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralL. Perrigo Company0113-0040
care one ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmerican Sales Company41520-255
infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralWalgreen Company0363-8139
profen ibibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralPublix Super Markets Inc56062-404
good neighbor pharmacy ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmerisource Bergen24385-550
infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralH E B37808-255
Good Sense ibuprofen infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralL. Perrigo Company0113-0057
Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralSafeway21130-513

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