What is NDC 53345-014?

53345-014 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 1 package NDC, 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?

674 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 53345-014 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53345-014Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53345-0014Add 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
53345-014-01	5334500140153345001401	1 BAG in 1 BOX (53345-014-01) / 10000 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Oct 6, 2016

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: Oct 6, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 53345-014_3cd90bef-d64d-4fb5-97db-2cd0a72c9098SPL ID 3cd90bef-d64d-4fb5-97db-2cd0a72c9098SPL set ID 50bab3b2-f710-46ff-96cd-1ec4d4658529RxCUI 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

N453345001401 followed by a unit qualifier and the quantity

Package 53345-0014-01. 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 Nov 22, 2019.

Indications (excerpt from the label)

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53345-014

What is NDC 53345-014?: 53345-014 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 1 package NDC, 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?: 674 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 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4784	70518-4784-0070518-4784-01
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4786	70518-4786-00
Ibuprofen	Ibuprofen 200 mg/1	TabletOral	Famora Inc	87509-0004	87509-0004-05
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Medcore LLC	82461-724	82461-0724-90
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Medcore LLC	82461-725	82461-0725-90
Ibuprofen	Ibuprofen 200 mg/1	TabletOral	Aurohealth LLC	58602-913	58602-0913-1758602-0913-40
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 800 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-739	67877-0739-0167877-0739-0567877-0739-30+4 more
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	GOODSENSE	50804-185	50804-0185-0150804-0185-02

All 675 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 minisibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Walgreens	0363-0743
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Topco Associates LLC	36800-440
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-741
Ibuprofen minisibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	CVS Pharmacy	69842-643
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Care One (Retail Business Services, LLC.)	72476-745
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	The Kroger Co.	30142-745
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	CVS Pharmacy	69842-649
Ibuprofen minisibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Care One (Retail Business Services, LLC.)	72476-843
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	P & L Development, LLC	59726-745
Ibuprofen minisibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	P & L Development, LLC	59726-843
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Walgreens	0363-0945
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Care One (American Sales Company)	41520-745
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-845
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Best Choice (Valu Merchandisers Company)	63941-745
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Family Dollar (FAMILY WELLNESS)	55319-552
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	53345-039
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	53345-039
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	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	53345-059

Showing 20 of 38.