Over-the-counter drug · ANDA

Motrin IB (Ibuprofen) NDC 53209-2001

Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · Morning Star OTC

NDC codes

FDA NDC Directory
Product NDC (as listed)53209-2001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53209-2001Add 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
53209-2001-2532092001025320920010225 BLISTER PACK in 1 POUCH (53209-2001-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-2001-1)Marketed from Jun 19, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Motrin IB
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Morning Star OTCNDC labeler code 53209
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077349
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 53209-2001_37e92a7b-971f-c212-e063-6394a90ad710SPL ID 37e92a7b-971f-c212-e063-6394a90ad710SPL set ID e69f00c4-b8ec-4a83-9eea-8cb2835ad776RxCUI 201126, 310965UNII 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

N453209200102 followed by a unit qualifier and the quantity

Package 53209-2001-02. 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: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53209-2001

What is NDC 53209-2001?
53209-2001 is the product NDC for Motrin IB (ibuprofen), Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by Morning Star OTC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Motrin IB (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Morning Star OTC, NDC labeler code 53209. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Motrin IB?
8 other product NDCs are listed under this name. See all Motrin IB 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 Motrin IB NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Motrin IBibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralSavings Distributors LLC73097-02873097-0028-0273097-0028-4073097-0028-50
Motrin IbibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralR J General Corporation70264-02970264-0029-01
Motrin IBibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralNavajo Manufacturing Company Inc.67751-12067751-0120-0167751-0120-02
Motrin IBibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-23050580-0230-0150580-0230-0250580-0230-03+6 more
Motrin IBibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralJones Healthcare Group - Packaging Services, Inc67414-24067414-0240-0067414-0240-09
Motrin IBibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralSelect Consumer Group LLC85237-194785237-1947-0185237-1947-0285237-1947-04+2 more
Motrin IBibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralKenvue Brands LLC50580-40950580-0409-1250580-0409-2050580-0409-80
Motrin IBibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLil' Drug Store Products, Inc.66715-981266715-9812-0266715-9812-0366715-9812-08

Other NDCs under ANDA 077349

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

FDA NDC Directory listings under ANDA 077349
ProductStrengthForm · routeLabelerProduct NDC
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-517
CareOne IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-495
Topcare ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralTopco Associates LLC36800-517
Equate IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-517
ibuprofen 200ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-1517
Motrin IBibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLil' Drug Store Products, Inc.66715-9812
Good Sense ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralL. Perrigo Company0113-0517
dg health ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDolgencorp Inc55910-758
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-143
leader ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. dba Leader70000-0003
kirkland signature ibuprofen ibibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCostco Wholesale Company63981-517
Motrin IBibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralJones Healthcare Group - Packaging Services, Inc67414-240
Motrin IB, TRAVEL BASIXibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLil' Drug Store Products, Inc.66715-6412
Ibuprofen 200mgIbuprofen 200 mg/1Tablet, Film coatedOralAllegiant Health69168-390
Motrin IBibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-230
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCVS Pharmacy59779-517
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralH E B37808-709
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-517
Motrin IB, CVP HEALTHibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLil' Drug Store Products, Inc.66715-6512
Motrin IBibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralSelect Consumer Group LLC85237-1947

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