What is NDC 53345-039?

53345-039 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd, NDC labeler code 53345. 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 53345-039 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53345-039Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53345-0039Add 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
53345-039-02	53345003902	24 BOTTLE in 1 BOX (53345-039-02) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Jul 13, 2017
53345-039-03	53345003903	100 BOTTLE in 1 BOX (53345-039-03) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Jul 13, 2017

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: Capsule, Liquid filled
Route: Oral
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan) Co., LtdNDC labeler code 53345
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206568
Marketing start: Jul 13, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 53345-039_8748389d-27ff-47b5-bbe9-03592e2d7d45SPL ID 8748389d-27ff-47b5-bbe9-03592e2d7d45SPL set ID f42506f7-896c-47a9-a4b1-ed72434d7aa0RxCUI 310964UNII WK2XYI10QM
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

N453345003902 followed by a unit qualifier and the quantity

Package 53345-0039-02. 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 Nov 22, 2019.

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 53345-039

What is NDC 53345-039?: 53345-039 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 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?: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd, NDC labeler code 53345. 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 206568

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

FDA NDC Directory listings under ANDA 206568
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	CVS Pharmacy	69842-745
Ibuprofen mini	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	53345-050
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Sam's West, Inc	68196-745
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	53345-059
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Sam's West, Inc.	68196-981
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Best Choice (Valu Merchandisers Company)	63941-745
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Topco Associates LLC	36800-440
Ibuprofen minisibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-953
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	PuraCap Pharmaceutical LLC	51013-103
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	PuraCap Pharmaceutical LLC	51013-421
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	PuraCap Pharmaceutical LLC	51013-405
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	PuraCap Pharmaceutical LLC	51013-410
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	PuraCap Pharmaceutical LLC	51013-422
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	PURACAP PHARMACEUTICAL LLC	51013-429
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	The Kroger Co.	30142-745
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	AAFES/Your Military Exchanges	55301-745
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Rugby Laboratories, Inc.	0536-1147
Ibuprofen minisibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	WR Group, Inc.	69607-8438
Ibuprofen minisibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Walgreens	0363-0743
Ibuprofen minisibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Strategic Sourcing Services LLC	70677-1113

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