Over-the-counter drug · ANDA

topcare childrens ibuprofen (Ibuprofen) NDC 36800-166

Ibuprofen 100 mg/5mL · Suspension · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-166Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0166Add 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
36800-166-26368000166261 BOTTLE in 1 CARTON (36800-166-26) / 120 mL in 1 BOTTLEMarketed from Jul 30, 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 childrens ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 100 mg/5mL
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 074937
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 36800-166_1964b704-6b43-42cc-b66e-f0552f45bb98SPL ID 1964b704-6b43-42cc-b66e-f0552f45bb98SPL set ID d1bb68a6-3a29-4a4e-b4e9-413cc8d16191RxCUI 197803UNII 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

N436800016626 followed by a unit qualifier and the quantity

Package 36800-0166-26. 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 the common cold, flu, sore throat, headache and toothache • reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-166

What is NDC 36800-166?
36800-166 is the product NDC for topcare childrens ibuprofen (ibuprofen), Ibuprofen 100 mg/5mL 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 childrens 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 childrens ibuprofen?
2 other product NDCs are listed under this name. See all topcare childrens 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 childrens ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
topcare childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralTopco Associates LLC36800-81136800-0811-62
Topcare Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralTopco Associates LLC36800-66036800-0660-00

Other NDCs under ANDA 074937

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

FDA NDC Directory listings under ANDA 074937
ProductStrengthForm · routeLabelerProduct NDC
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-166
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-660
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-685
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-897
care one ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerican Sales Company41520-897
care one ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerican Sales Company41520-166
Care One ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerican Sales Company41520-685
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralRite Aid Corporation11822-0166
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralRite Aid Corporation11822-1685
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-506
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-510
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralH E B37808-200
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-419
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-685
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralHyVee Inc42507-685
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPadagis Israel Pharmaceuticals Ltd45802-133
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPadagis Israel Pharmaceuticals Ltd45802-140
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 107, LLC55154-1577
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCVS Pharmacy59779-971
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralNuCare Pharmaceuticals, Inc.68071-5290

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