Over-the-counter drug · ANDA

ibuprofen NDC 0904-6747

Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6747Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6747Add 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
0904-6747-24009046747241 BOTTLE in 1 CARTON (0904-6747-24) / 24 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 20, 2018
0904-6747-4000904674740500 TABLET, FILM COATED in 1 BOTTLE (0904-6747-40)Marketed from Sep 20, 2018
0904-6747-51009046747511 BOTTLE in 1 CARTON (0904-6747-51) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 20, 2018
0904-6747-59009046747591 BOTTLE in 1 CARTON (0904-6747-59) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 20, 2018
0904-6747-70009046747701 BOTTLE in 1 CARTON (0904-6747-70) / 250 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 20, 2018
0904-6747-80009046747801000 TABLET, FILM COATED in 1 BOTTLE (0904-6747-80)Marketed from Sep 20, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 072096
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0904-6747_dddfc800-cfd3-42d4-82e1-04414822fbfcSPL ID dddfc800-cfd3-42d4-82e1-04414822fbfcSPL set ID 14f43c32-0895-4ef2-aa54-52b952d058fdRxCUI 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

N400904674724 followed by a unit qualifier and the quantity

Package 00904-6747-24. 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

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 0904-6747

What is NDC 0904-6747?
0904-6747 is the product NDC for ibuprofen, Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
ibuprofen.
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ibuprofen?
664 other product NDCs are listed under this name. See all 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 ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IbuprofenIbuprofen 200 mg/1TabletOralAurohealth LLC58602-91358602-0913-1758602-0913-40
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73967877-0739-0167877-0739-0567877-0739-30+4 more
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73767877-0737-0167877-0737-0567877-0737-33+1 more
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73867877-0738-0167877-0738-0567877-0738-30+3 more
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralGOODSENSE50804-18550804-0185-0150804-0185-02
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralShield Pharmaceuticals Corp83059-018083059-0180-04
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralGobrands, Inc. (Goodnow)82501-101082501-1010-00
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-474170518-4741-0070518-4741-02
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralP & L Development, LLC59726-00359726-0003-50
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-14372288-0143-7872288-0143-90

All 665 ibuprofen NDCs

Other NDCs under ANDA 072096

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

FDA NDC Directory listings under ANDA 072096
ProductStrengthForm · routeLabelerProduct NDC
365 whole foods market ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWhole Foods Market, INC.42681-0026
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-311
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-604
Berkley and Jensen IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBJWC68391-604
betr pain reliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-604
betr remedies ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-999
care one ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-604
careone ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-647
CounterAct IBibuprofenIbuprofen 200 mg/1Tablet, CoatedOralMelaleuca, Inc54473-306
dg health ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDolgencorp, LLC55910-604
dg health ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDolgencorp Inc55910-647
equaline ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-604
equaline ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-647
Equate IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-553
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-604
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-647
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1132
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1136
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-604
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-647

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