Over-the-counter drug · ANDA

Childrens Ibuprofen Oral Suspension (Ibuprofen) NDC 53943-119

Ibuprofen 100 mg/5mL · Suspension · Oral · Discount Drug Mart

NDC codes

FDA NDC Directory
Product NDC (as listed)53943-119Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0119Add 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
53943-119-2453943011924539430119241 BOTTLE in 1 CARTON (53943-119-24) / 118 mL in 1 BOTTLEMarketed from Aug 16, 2019

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
Discount Drug MartNDC labeler code 53943
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 53943-119_465376e9-bf3f-2a69-e063-6294a90a6a4cSPL ID 465376e9-bf3f-2a69-e063-6294a90a6a4cSPL set ID 7b7954b7-e4c8-4284-a649-31a4eb6ba73eRxCUI 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

N453943011924 followed by a unit qualifier and the quantity

Package 53943-0119-24. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 53943-119

What is NDC 53943-119?
53943-119 is the product NDC for Childrens Ibuprofen Oral Suspension, Ibuprofen 100 mg/5mL suspension, listed with the FDA by Discount Drug Mart. 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?
Discount Drug Mart, NDC labeler code 53943. 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/5mLSuspensionOralChain Drug Marketing Association, Inc.63868-79663868-0796-04
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/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/5mLSuspensionOralChain Drug Marketing Association, Inc.63868-796
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

Showing 20 of 37.

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