Over-the-counter drug · ANDA

Childrens Ibuprofen Oral Suspension (Ibuprofen) NDC 63868-796

Ibuprofen 100 mg/5mL · Suspension · Oral · Chain Drug Marketing Association, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)63868-796Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0796Add 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
63868-796-0463868079604638680796041 BOTTLE in 1 CARTON (63868-796-04) / 118 mL in 1 BOTTLEMarketed from Dec 15, 2020

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)
Childrens Ibuprofen Oral Suspension
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 100 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Chain Drug Marketing Association, Inc.NDC labeler code 63868
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210602
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 63868-796_5c369278-435d-4c67-991c-b4117eb90e4eSPL ID 5c369278-435d-4c67-991c-b4117eb90e4eSPL set ID f0959369-890e-403e-8a98-4eda340a0783RxCUI 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

N463868079604 followed by a unit qualifier and the quantity

Package 63868-0796-04. 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 63868-796

What is NDC 63868-796?
63868-796 is the product NDC for Childrens Ibuprofen Oral Suspension, Ibuprofen 100 mg/5mL suspension, listed with the FDA by Chain Drug Marketing Association, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens Ibuprofen Oral Suspension (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Chain Drug Marketing Association, Inc., NDC labeler code 63868. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Childrens Ibuprofen Oral Suspension?
9 other product NDCs are listed under this name. See all Childrens Ibuprofen Oral Suspension 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 Childrens Ibuprofen Oral Suspension NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-083300121-0833-0000121-0833-40
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 200 mg/10mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-166600121-1666-0000121-1666-40
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralReliable 1 Laboratories LLC69618-07869618-0078-54
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralAptaPharma Inc.76281-11976281-0119-24
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralMarc Glassman, Inc.68998-32068998-0320-24
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralDEMOULAS SUPERMARKETS INC.53942-11953942-0119-24
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralDiscount Drug Mart53943-11953943-0119-24
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralPharmaceutical Associates, Inc.0121-091400121-0914-00
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/10mLSuspensionOralPharmaceutical Associates, Inc.0121-182800121-1828-00

Other NDCs under ANDA 210602

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

FDA NDC Directory listings under ANDA 210602
ProductStrengthForm · routeLabelerProduct NDC
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerican Health Packaging60687-743
Childrens Ibuprofen GrapeibuprofenIbuprofen 100 mg/5mLSuspensionOralAptaPharma Inc.76281-126
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralDEMOULAS SUPERMARKETS INC.53942-119
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralDiscount Drug Mart53943-119
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralMarc Glassman, Inc.68998-320
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralAptaPharma Inc.76281-119
Childrens Ibuprofen Oral Suspension Dye freeibuprofenIbuprofen 100 mg/5mLSuspensionOralAptaPharma Inc.76281-128
Childrens Ibuprofen Oral Suspension Dye FreeibuprofenIbuprofen 100 mg/5mLSuspensionOralFSA Store Inc. (Caring Mill)81522-311
Childrens Ibuprofen Oral Suspension Original Berry FlavoribuprofenIbuprofen 100 mg/5mLSuspensionOralPuro Pharma Inc.83474-002
Childrens Ibuprofen Oral Suspension, Bubble GumibuprofenIbuprofen 100 mg/5mLSuspensionOralBest Choice63941-127
Childrens Ibuprofen Oral Suspension, Dye FreeibuprofenIbuprofen 100 mg/5mLSuspensionOralBest Choice63941-128
Dolex ChildrenibuprofenIbuprofen 100 mg/100mLLiquidOralPharmadel LLC55758-304
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralA-S Medication Solutions50090-4129
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8540
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8851
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8852
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8853
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralNuCare Pharmaceuticals,Inc.68071-1628
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralCamber Consumer Care Inc69230-308
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralCamber Consumer Care Inc69230-309

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