NDC codes

FDA NDC Directory
Product NDC (as listed)55154-1342Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-1342Add 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
55154-1342-05515413420010 BLISTER PACK in 1 BAG (55154-1342-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 10, 2009

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)
Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen800 mg/1
Dosage form
Tablet, Film coated
Route
Oral
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 55154-1342_bbd0e3a5-5432-41f7-816c-16ad6e240da0SPL ID bbd0e3a5-5432-41f7-816c-16ad6e240da0SPL set ID 8ea0e303-3967-4d71-8255-ac42a841ce28RxCUI 197805, 197806, 197807UNII WK2XYI10QMUPC 0055154138000, 0055154074100

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

N455154134200 followed by a unit qualifier and the quantity

Package 55154-1342-00. 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)

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
IbuprofenIbuprofen 600 mg/1TabletOralMajor Pharmaceuticals0904-5854
IbuibuprofenIbuprofen 400 mg/1TabletOralProficient Rx LP71205-604
IbuibuprofenIbuprofen 600 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-501
IbuprofenIbuprofen 800 mg/1TabletOralMajor Pharmaceuticals0904-5855
IbuibuprofenIbuprofen 800 mg/1TabletOralNuCare Pharmaceuticals,Inc.66267-963
IbuibuprofenIbuprofen 600 mg/1TabletOralNuCare Pharmaceuticals Inc.66267-964
IbuibuprofenIbuprofen 800 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3053
IbuibuprofenIbuprofen 800 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-550
IbuprofenIbuprofen 400 mg/1TabletOralBryant Ranch Prepack63629-1468
IbuprofenIbuprofen 600 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-891
IbuprofenIbuprofen 800 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-892
IbuibuprofenIbuprofen 400 mg/1TabletOralGolden State Medical Supply, Inc.51407-369
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0741
IbuprofenIbuprofen 600 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-9111
IbuprofenIbuprofen 400 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-9110
IbuprofenIbuprofen 800 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-9112
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-1380
IbuibuprofenIbuprofen 600 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-547
IbuprofenIbuprofen 400 mg/1TabletOralGolden State Medical Supply, Inc.51407-839
IbuIbuprofen 600 mg/1TabletOralRedPharm Drug, Inc.67296-0913

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