What is NDC 53345-033?

53345-033 is the product NDC for Simethicone, Dimethicone 125 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?

18 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 53345-033 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53345-033Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53345-0033Add 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
53345-033-01	53345003301	1 BAG in 1 BOX (53345-033-01) / 25000 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Jan 28, 2015

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 — 125 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.NDC labeler code 53345
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 002
Marketing start: Jan 28, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Skin Barrier Activity (Physiologic effect)
Identifiers: Product ID 53345-033_27c7f645-cfa7-6db1-e063-6394a90a42ffSPL ID 27c7f645-cfa7-6db1-e063-6394a90a42ffSPL set ID f7c40b12-11e4-4b85-afb2-0ea33e4f218cRxCUI 198852UNII 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

N453345003301 followed by a unit qualifier and the quantity

Package 53345-0033-01. 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 25, 2024.

Indications (excerpt from the label)

Uses for relief of pressure, bloating, and 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 53345-033

What is NDC 53345-033?: 53345-033 is the product NDC for Simethicone, Dimethicone 125 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?: 18 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)
Simethicone	Dimethicone 500 mg/1	Capsule, Liquid filledOral	SOFTGEL HEALTHCARE PRIVATE LIMITED	35916-1942	35916-1942-01
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 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 250 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	53345-032	53345-0032-02

All 19 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
meijer ULTRA STRENGTH Gas Relief SOFTGELsimethicone	Dimethicone, Unspecified 180 mg/1	Capsule, Liquid filledOral	Meijer, Inc.	79481-0814
Anti-Gas Ultra Strengthsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	Best Choice (Valu Merchandisers Company)	63941-773
Gas Relief SIMETHICONE 250 mg Anti-gassimethicone	Dimethicone 250 mg/1	Tablet, ChewableOral	CVS Pharmacy, Inc.	51316-702
Gas Relief Ultra Strengthdimethicone	Dimethicone, Unspecified 180 mg/1	Capsule, Liquid filledOral	TOPCO ASSOCIATES LLC	36800-324
basic care gas reliefsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Amazon.com Services LLC	72288-428
Gas Reliefsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Family Dollar (FAMILY WELLNESS)	55319-555
Gas Reliefsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Meijer Distribution, Inc.	79481-0608
Pepto Gas plus Bloatingsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	The Procter & Gamble Manufacturing Company	84126-378
Gas Relief Extra Strengthsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	H E B	37808-797
Ultrastrength Gas Reliefsimethicone soft gelatin capsules	Dimethicone 180 mg/1	CapsuleOral	CVS PHARMACY, INC	51316-621
up and up extra strength gas relief chewables Extra Strengthsimethicone	Dimethicone, Unspecified 125 mg/1	Tablet, ChewableOral	Target Corporation	11673-610
mylanta gassimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Infirst Healthcare	62372-554
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	53345-032
Extra Strength Gas Reliefsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Geri-Care Pharmaceuticals, Corp	57896-292
Mylicon Infants Gas Relief Originalsimethicone	Dimethicone 20 mg/.3mL	EmulsionOral	Infirst Healthcare	62372-630
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	53345-032
Mylicon Infants Gas Relief Dye Freesimethicone	Dimethicone 20 mg/.3mL	EmulsionOral	Infirst Healthcare	62372-650
Gas Relief Extra Strengthsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	P & L Development, LLC	59726-897
HEB Gas Relief Extra Strength Peppermintsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	H E B	37808-155
Gas Relief Ultra Strengthsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	United Natural Foods, Inc. dba UNFI	41163-832

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