What is NDC 53746-458?

53746-458 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ibuprofen NDC 53746-458 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-458Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0458Add 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	Copy
53746-458-02	53746045802	250 TABLET in 1 BOTTLE (53746-458-02)Marketed from Apr 30, 2013
53746-458-10	53746045810	1000 TABLET in 1 BOTTLE (53746-458-10)Marketed from Apr 30, 2013

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 — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079233
Marketing start: Apr 30, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 53746-458_0a178197-17b9-4e74-a85b-abd0ba469966SPL ID 0a178197-17b9-4e74-a85b-abd0ba469966SPL set ID 59f14d2b-f48a-4c25-bea3-3dc9100898b2RxCUI 310965UNII WK2XYI10QMUPC 0353746462022, 0353746458025, 0353746460028
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

N453746045802 followed by a unit qualifier and the quantity

Package 53746-0458-02. 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 Dec 31, 2023.

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 53746-458

What is NDC 53746-458?: 53746-458 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 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?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ibuprofen	Ibuprofen 200 mg/1	TabletOral	Aurohealth LLC	58602-913	58602-0913-1758602-0913-40
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-739	67877-0739-0167877-0739-0567877-0739-30+4 more
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-737	67877-0737-0167877-0737-0567877-0737-33+1 more
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-738	67877-0738-0167877-0738-0567877-0738-30+3 more
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	GOODSENSE	50804-185	50804-0185-0150804-0185-02
Ibuprofen	Ibuprofen 200 mg/1	Tablet, CoatedOral	Shield Pharmaceuticals Corp	83059-0180	83059-0180-04
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Gobrands, Inc. (Goodnow)	82501-1010	82501-1010-00
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4741	70518-4741-0070518-4741-02
Ibuprofen	Ibuprofen 200 mg/1	Tablet, CoatedOral	P & L Development, LLC	59726-003	59726-0003-50
Ibuprofen	Ibuprofen 200 mg/1	Tablet, Film coatedOral	Amazon.com Services LLC	72288-143	72288-0143-7872288-0143-90

All 665 Ibuprofen NDCs

Other NDCs under ANDA 079233

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

FDA NDC Directory listings under ANDA 079233
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen	Ibuprofen 200 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-460
Ibuprofen	Ibuprofen 200 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-462