Over-the-counter drug · ANDA

Childrens Motrin (Ibuprofen) NDC 50580-932

Ibuprofen 100 mg/1 · Tablet, Chewable · Oral · Kenvue Brands LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)50580-932Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0932Add 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
50580-932-0150580093201505800932011 BOTTLE in 1 CARTON (50580-932-01) / 24 TABLET, CHEWABLE in 1 BOTTLEMarketed from Jun 17, 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 Motrin
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 100 mg/1
Dosage form
Tablet, Chewable
Route
Oral
Labeler
Kenvue Brands LLCNDC labeler code 50580
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076359
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 50580-932_408cbc93-a3f6-8fb8-e063-6294a90a1829SPL ID 408cbc93-a3f6-8fb8-e063-6294a90a1829SPL set ID 15b0b56d-6188-4937-b541-902022e35b24RxCUI 310963, 792242UNII WK2XYI10QMUPC 0300450932266

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

N450580093201 followed by a unit qualifier and the quantity

Package 50580-0932-01. 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 50580-932

What is NDC 50580-932?
50580-932 is the product NDC for Childrens Motrin (ibuprofen), Ibuprofen 100 mg/1 tablet, chewable, listed with the FDA by Kenvue Brands LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens Motrin (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Kenvue Brands LLC, NDC labeler code 50580. 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 Motrin?
5 other product NDCs are listed under this name. See all Childrens Motrin 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 Motrin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Childrens MotrinibuprofenIbuprofen 100 mg/1Tablet, ChewableOralKenvue Brands LLC50580-93350580-0933-01
Childrens MotrinibuprofenIbuprofen 100 mg/5mLSuspensionOralKenvue Brands LLC50580-60350580-0603-04
Childrens MotrinibuprofenIbuprofen 100 mg/5mLSuspensionOralKenvue Brands LLC50580-60450580-0604-04
Childrens MotrinibuprofenIbuprofen 100 mg/5mLSuspensionOralKenvue Brands LLC50580-18450580-0184-0150580-0184-5050580-0184-52
Childrens MOTRINibuprofenIbuprofen 100 mg/5mLSuspensionOralKenvue Brands LLC50580-60150580-0601-0850580-0601-2050580-0601-21+2 more

Other NDCs under ANDA 076359

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

FDA NDC Directory listings under ANDA 076359
ProductStrengthForm · routeLabelerProduct NDC
Up and Up Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralTarget Corporation11673-741
childrens ibuprofen 100ibuprofenIbuprofen 100 mg/1Tablet, ChewableOralWalgreen Company0363-1461
Good Neighbor Pharmacy Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmerisource Bergen46122-617
good neighbor pharmacy childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmerisource Bergen46122-632
Leader IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralCardinal Health 110, LLC. dba Leader70000-0239
foster and thrive childrens ibuprofen ibibuprofenIbuprofen 100 mg/1Tablet, ChewableOralStrategic Sourcing Services LLC70677-1145
ibuprofenIbuprofen 100 mg/1Tablet, ChewableOralHyVee Inc42507-461
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmazon.com Services LLC72288-763
Childrens MotrinibuprofenIbuprofen 100 mg/1Tablet, ChewableOralKenvue Brands LLC50580-933
careone childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmerican Sales Company41520-740
equate ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralWal-Mart Stores Inc49035-521
Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralPublix Super Markets Inc56062-801
childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralCVS Pharmacy69842-706
childrens ibuprofen 100ibuprofenIbuprofen 100 mg/1Tablet, ChewableOralWalgreen Company0363-1521
Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralRite Aid Corporation11822-4461
signature care childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralSafeway21130-701
Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmazon.com Services LLC72288-320
childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralCVS Pharmacy69842-329
childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralMeijer Distribution Inc41250-331
Good Sense Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralL. Perrigo Company0113-7366

Showing 20 of 37.

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