Over-the-counter drug · ANDA

Childrens Ibuprofen (Ibuprofen) NDC 45802-140

Ibuprofen 100 mg/5mL · Suspension · Oral · Padagis Israel Pharmaceuticals Ltd

NDC codes

FDA NDC Directory
Product NDC (as listed)45802-140Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45802-0140Add 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
45802-140-2645802014026458020140261 BOTTLE in 1 CARTON (45802-140-26) / 118 mL in 1 BOTTLEMarketed from Apr 9, 2014

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
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 100 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
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 45802-140_3d650640-4fe5-4707-b722-4e72f4ace7d7SPL ID 3d650640-4fe5-4707-b722-4e72f4ace7d7SPL set ID efb728f2-fe74-4833-8f0c-710d833abf6eRxCUI 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

N445802014026 followed by a unit qualifier and the quantity

Package 45802-0140-26. 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 45802-140

What is NDC 45802-140?
45802-140 is the product NDC for Childrens Ibuprofen (ibuprofen), Ibuprofen 100 mg/5mL suspension, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens Ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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?
54 other product NDCs are listed under this name. See all 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 Childrens Ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-39272288-0392-34
Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmazon.com Services LLC72288-32072288-0320-62
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAdvagen Pharma Ltd.72888-47972888-0479-01
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPreferred Pharmaceuticals Inc.68788-403168788-4031-01
childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralSafeway21130-79021130-0790-62
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-50621130-0506-26
Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralMeijer, Inc.79481-041979481-0419-00
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-51021130-0510-26
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralBetter Living Brands, LLC21130-21621130-0216-20
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralDiscount Drug Mart, Inc53943-68253943-0682-03

All 55 Childrens Ibuprofen NDCs

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
equate ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralWal-Mart Stores Inc49035-660
Ibuprofen ChildrensibuprofenIbuprofen 100 mg/5mLSuspensionOralWalgreen Company0363-0660
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-779
DG Health IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralDolgencorp Inc55910-897
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPrecision Dose Inc.68094-494
good sense ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralPreferred Pharmaceuticals Inc.68788-4196
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPrecision Dose Inc.68094-503
Topcare Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralTopco Associates LLC36800-660
ibuprofenIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-2341
ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralWalgreen Company0363-0166
Dye Free Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPrecision Dose Inc.68094-600
IbuprofenIbuprofen 100 mg/5mLSuspensionOralCVS Pharmacy59779-166
ibuprofenIbuprofen 100 mg/5mLSuspensionOralH E B37808-023
topcare childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralTopco Associates LLC36800-166
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-897
ibuprofenIbuprofen 100 mg/5mLSuspensionOralRite Aid Corporation11822-0660
up and up ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralTarget Corporation11673-685
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-419
Up and Up childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralTarget Corporation11673-166
equate ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralWal-Mart Stores Inc49035-166

Showing 20 of 39.

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