Ibuprofen NDC 53746-465

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-465Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0465Add 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 NDC	11-digit (billing)	Package
53746-465-01	53746046501	100 TABLET in 1 BOTTLE (53746-465-01)Marketed from Nov 23, 2009
53746-465-05	53746046505	500 TABLET in 1 BOTTLE (53746-465-05)Marketed from Nov 23, 2009
53746-465-30	53746046530	30 TABLET in 1 BOTTLE (53746-465-30)Marketed from Nov 23, 2009
53746-465-50	53746046550	50 TABLET in 1 BOTTLE (53746-465-50)Marketed from Nov 23, 2009
53746-465-60	53746046560	60 TABLET in 1 BOTTLE (53746-465-60)Marketed from Nov 23, 2009
53746-465-90	53746046590	90 TABLET in 1 BOTTLE (53746-465-90)Marketed from Nov 23, 2009

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): Ibuprofen
Generic name (nonproprietary): ibuprofen
Active ingredients: Ibuprofen — 600 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078558
Marketing start: Nov 23, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 53746-465_769cfd1d-35d7-4f1a-ad8b-1bf642e02075SPL ID 769cfd1d-35d7-4f1a-ad8b-1bf642e02075SPL set ID faebc392-0fd9-4c71-8471-beba10dda022RxCUI 197805, 197806, 197807UNII WK2XYI10QMUPC 0353746465016, 0353746464019, 0353746466013
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

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

N453746046501 followed by a unit qualifier and the quantity

Package 53746-0465-01. 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 Jul 29, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual 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 078558

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

FDA NDC Directory listings under ANDA 078558
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen	Ibuprofen 400 mg/1	TabletOral	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	83209-464
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	PHOENIX RX LLC	85509-1466
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3415
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	Bryant Ranch Prepack	63629-1470
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-898
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0047
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	Proficient Rx LP	63187-022
Ibuprofen	Ibuprofen 400 mg/1	TabletOral	Proficient Rx LP	63187-489
Ibuprofen	Ibuprofen 400 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-464
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-466
Ibuprofen	Ibuprofen 600 mg/1	TabletOral	Proficient Rx LP	63187-527
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	A-S Medication Solutions	50090-6616
Ibuprofen	Ibuprofen 400 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2583
Ibuprofen	Ibuprofen 400 mg/1	TabletOral	American Health Packaging	60687-446
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-466
Ibuprofen	Ibuprofen 400 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-464
Ibuprofen	Ibuprofen 600 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-465
Ibuprofen	Ibuprofen 600 mg/1	TabletOral	American Health Packaging	60687-457
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	Proficient Rx LP	63187-962
Ibuprofen	Ibuprofen 800 mg/1	TabletOral	American Health Packaging	60687-468