NDC codes

FDA NDC Directory
Product NDC (as listed)71610-547Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0547Add 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
71610-547-607161005476090 TABLET in 1 BOTTLE (71610-547-60)Marketed from Apr 30, 2021
71610-547-8071610054780180 TABLET in 1 BOTTLE (71610-547-80)Marketed from Apr 30, 2021
71610-547-9271610054792270 TABLET in 1 BOTTLE (71610-547-92)Marketed from Apr 30, 2021

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)
Ibu
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 600 mg/1
Dosage form
Tablet
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 71610-547_19cc7ade-51b3-44f2-9bb1-a7a22909af97SPL ID 19cc7ade-51b3-44f2-9bb1-a7a22909af97SPL set ID b0f03994-b744-4d66-95b7-8c86217882bcUNII 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

N471610054760 followed by a unit qualifier and the quantity

Package 71610-0547-60. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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 400 mg/1TabletOralMajor Pharmaceuticals0904-5853
IbuprofenIbuprofen 800 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-967
IbuprofenIbuprofen 600 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-968
IbuprofenIbuprofen 400 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-969
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/1TabletOralProficient Rx LP63187-614
IbuprofenIbuprofen 600 mg/1TabletOralMajor Pharmaceuticals0904-5854
IbuprofenIbuprofen 800 mg/1TabletOralMajor Pharmaceuticals0904-5855
IbuibuprofenIbuprofen 400 mg/1TabletOralProficient Rx LP71205-604
IbuibuprofenIbuprofen 600 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-501
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
IbuibuprofenIbuprofen 400 mg/1TabletOralGolden State Medical Supply, Inc.51407-369
IbuprofenIbuprofen 800 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-892

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