NDC codes

FDA NDC Directory
Product NDC (as listed)0904-5855Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-5855Add 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
0904-5855-400090458554000904585540500 TABLET in 1 BOTTLE (0904-5855-40)Marketed from Jun 10, 2009
0904-5855-600090458556000904585560100 TABLET in 1 BOTTLE (0904-5855-60)Marketed from Jun 10, 2009
0904-5855-610090458556100904585561100 BLISTER PACK in 1 CARTON (0904-5855-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 10, 2009

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 — 800 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075682
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0904-5855_4328fb1d-573c-4d05-8019-1d2c29360cc5SPL ID 4328fb1d-573c-4d05-8019-1d2c29360cc5SPL set ID ba86e936-ef72-43e5-aebf-f2c788fe2266RxCUI 197805, 197806, 197807UNII 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

N400904585540 followed by a unit qualifier and the quantity

Package 00904-5855-40. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-5855

What is NDC 0904-5855?
0904-5855 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 3 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?
674 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 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478470518-4784-0070518-4784-01
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478670518-4786-00
IbuprofenIbuprofen 200 mg/1TabletOralFamora Inc87509-000487509-0004-05
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralMedcore LLC82461-72582461-0725-90
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralMedcore LLC82461-72482461-0724-90
IbuprofenIbuprofen 200 mg/1TabletOralAurohealth LLC58602-91358602-0913-1758602-0913-40
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73867877-0738-0167877-0738-0567877-0738-30+3 more
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73767877-0737-0167877-0737-0567877-0737-33+1 more
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73967877-0739-0167877-0739-0567877-0739-30+4 more
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralGOODSENSE50804-18550804-0185-0150804-0185-02

All 675 Ibuprofen NDCs

Other NDCs under ANDA 075682

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

FDA NDC Directory listings under ANDA 075682
ProductStrengthForm · routeLabelerProduct NDC
IbuibuprofenIbuprofen 800 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-275
IbuibuprofenIbuprofen 600 mg/1TabletOralProficient Rx LP63187-614
IbuibuprofenIbuprofen 400 mg/1TabletOralDr. Reddy's Laboratories Limited55111-682
IbuibuprofenIbuprofen 600 mg/1TabletOralDr. Reddy's Laboratories Limited55111-683
IbuibuprofenIbuprofen 800 mg/1TabletOralDr. Reddy's Laboratories Limited55111-684
IbuibuprofenIbuprofen 600 mg/1TabletOralNuCare Pharmaceuticals Inc.66267-964
IbuibuprofenIbuprofen 800 mg/1TabletOralNuCare Pharmaceuticals,Inc.66267-963
IbuibuprofenIbuprofen 800 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3053
IbuprofenIbuprofen 800 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-967
IbuprofenIbuprofen 600 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-968
IbuprofenIbuprofen 600 mg/1TabletOralMajor Pharmaceuticals0904-5854
IbuprofenIbuprofen 400 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-969
IbuibuprofenIbuprofen 400 mg/1TabletOralProficient Rx LP71205-604
IbuibuprofenIbuprofen 600 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-501
IbuprofenIbuprofen 400 mg/1TabletOralBryant Ranch Prepack63629-1468
IbuibuprofenIbuprofen 600 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-547
IbuibuprofenIbuprofen 800 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-550
IbuprofenIbuprofen 400 mg/1TabletOralMajor Pharmaceuticals0904-5853
IbuprofenIbuprofen 400 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-9110
IbuprofenIbuprofen 600 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-9111

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