What is NDC 53345-032?

53345-032 is the product NDC for Simethicone, Dimethicone 250 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 Simethicone?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Simethicone NDC 53345-032 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53345-032Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53345-0032Add 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
53345-032-02	5334500320253345003202	124 BLISTER PACK in 1 BOX (53345-032-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jun 30, 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): Simethicone
Generic name (nonproprietary): simethicone
Active ingredients: Dimethicone — 250 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: OTC monograph drugApplication M 002
Marketing start: Jun 30, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Skin Barrier Activity (Physiologic effect)
Identifiers: Product ID 53345-032_27c7f645-cf9a-6db1-e063-6394a90a42ffSPL ID 27c7f645-cf9a-6db1-e063-6394a90a42ffSPL set ID 0c9c5fec-ddd4-41a5-8ff9-6b55c376dd36RxCUI 412111UNII 92RU3N3Y1O

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

N453345003202 followed by a unit qualifier and the quantity

Package 53345-0032-02. 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 25, 2024.

Indications (excerpt from the label)

Use relieves bloating, pressure or fullness commonly referred to as gas

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53345-032

What is NDC 53345-032?: 53345-032 is the product NDC for Simethicone, Dimethicone 250 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?: Simethicone.
What is the active ingredient?: Dimethicone.
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 Simethicone?: 17 other product NDCs are listed under this name. See all Simethicone 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 Simethicone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Simethiconetarget berry blast antacid hbg chew	Dimethicone 80 mg/1; Calcium carbonate 750 mg/1	Tablet, ChewableOral	Target	11673-549	11673-0549-60
Simethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	YYBA	73581-302	73581-0302-36
Simethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Softgel Healthcare Pvt Ltd	35916-1938	35916-1938-0135916-1938-0235916-1938-03
Simethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	SOFTGEL HEALTHCARE PRIVATE LIMITED	35916-1939	35916-1939-0135916-1939-02
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	SOFTGEL HEALTHCARE PRIVATE LIMITED	35916-1940	35916-1940-0135916-1940-02
Simethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	AMZ789 LLC	73629-002	73629-0002-18
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	WALMART INC.	79903-020	79903-0020-22
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	WALGREEN CO.	0363-9945	00363-9945-02
Simethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	53345-036	53345-0036-01
Simethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	53345-033	53345-0033-01

All 18 Simethicone NDCs

Other NDCs under M 002

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

FDA NDC Directory listings under M 002
Product	Strength	Form · route	Labeler	Product NDC
Phazymesimethicone	Dimethicone 250 mg/1	Capsule, Gelatin coatedOral	C.B. Fleet Company, Inc.	0132-0211
GNP Stomach Reliefbismuth subsalicylate 525 mg	Bismuth subsalicylate 525 mg/30mL	LiquidOral	Amerisource Bergen	46122-703
EXTRA STRENGTH gas reliefsimethicone	Dimethicone, Unspecified 125 mg/5mL	LiquidOral	KRAMER LABORATORIES	55505-225
SIMETHICONE INFANT Gas Relief Dropssimethicone	Dimethicone 20 mg/.3mL	SuspensionOral	Atlantic Biologicals Corp.	17856-1017
good sense gas reliefsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	L. Perrigo Company	0113-0657
Gencare-Gas Reliefsimethicone 180 mg	Dimethicone 180 mg/1	Capsule, Liquid filledOral	PIONEER LIFE SCIENCES, LLC	72090-073
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	WALMART INC.	79903-020
Ultra Strength Gas Reliefsimethicone	Dimethicone 180 mg/1	CapsuleOral	KROGER COMPANY	41226-717
SIMETHICONE INFANT Gas Relief Dropssimethicone	Dimethicone 20 mg/.3mL	SuspensionOral	Atlantic Biologicals Corp.	17856-1018
GNP Regular Strength Gas Reliefdimethicone	Dimethicone 80 mg/1	Tablet, ChewableOral	ATLANTIC BIOLOGICALS CORP.	17856-1118
Simethicone 125 mgsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Proficient Rx LP	82804-152
basic care gas reliefsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	Amazon.com Services LLC	72288-657
Infantssimethicone	Dimethicone, Unspecified 20 mg/.3mL	Suspension/ dropsOral	RUGBY LABORATORIES	0536-1303
WinCo FOODS Extra Strength Gas Reliefsimethicone	Dimethicone, Unspecified 125 mg/1	Tablet, ChewableOral	WINCO FOODS, LLC	67091-361
Extra Strength Gas Relief Cherry Flavorsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Discount Drug Mart, Inc	53943-134
Gas-Aidsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Leosons Overseas Corp	69626-7197
Extra Strength Gas Reliefsimethicone antigas	Dimethicone, Unspecified 125 mg/1	Tablet, ChewableOral	SAFEWAY	21130-441
Gas Relief Ultra Strengthsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	H E B	37808-874
TopCare health EXTRA STRENGTH Gas Relief SOFTGELsimethicone	Dimethicone, Unspecified 125 mg/1	Capsule, Liquid filledOral	Topco Associates LLC	76162-538
Gas Reliefsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	Safeway, Inc.	21130-446

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