Over-the-counter drug · OTC MONOGRAPH DRUG

Simethicone NDC 53345-009

Dimethicone 125 mg/1 · Capsule, Liquid filled · Oral · Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

NDC codes

FDA NDC Directory
Product NDC (as listed)53345-009Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53345-0009Add 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 NDC11-digit (billing)PackageCopy
53345-009-0153345000901533450009011 BAG in 1 BOX (53345-009-01) / 25000 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Apr 15, 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)
Simethicone
Generic name (nonproprietary)
simethicone
Active ingredients
Dimethicone — 125 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 002
Marketing start
Listing expires
Other FDA classes
Skin Barrier Activity (Physiologic effect)
Identifiers
Product ID 53345-009_2767d80e-d134-20a7-e063-6394a90aab4fSPL ID 2767d80e-d134-20a7-e063-6394a90aab4fSPL set ID 0f9639fa-e1d0-460d-bc46-714a01cd9811RxCUI 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

N453345000901 followed by a unit qualifier and the quantity

Package 53345-0009-01. 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 .

Indications (excerpt from the label)

Uses for relief of: bloating pressure fullness stuffed feeling 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 53345-009

What is NDC 53345-009?
53345-009 is the product NDC for Simethicone, Dimethicone 125 mg/1 capsule, liquid filled, listed with the FDA by Humanwell PuraCap Pharmaceutical (Wuhan), 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), 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Simethiconetarget berry blast antacid hbg chewDimethicone 80 mg/1; Calcium carbonate 750 mg/1Tablet, ChewableOralTarget11673-54911673-0549-60
SimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralYYBA73581-30273581-0302-36
SimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralSoftgel Healthcare Pvt Ltd35916-193835916-1938-0135916-1938-0235916-1938-03
SimethiconeDimethicone 180 mg/1Capsule, Liquid filledOralSOFTGEL HEALTHCARE PRIVATE LIMITED35916-193935916-1939-0135916-1939-02
SimethiconeDimethicone 250 mg/1Capsule, Liquid filledOralSOFTGEL HEALTHCARE PRIVATE LIMITED35916-194035916-1940-0135916-1940-02
SimethiconeDimethicone 180 mg/1Capsule, Liquid filledOralAMZ789 LLC73629-00273629-0002-18
SimethiconeDimethicone 250 mg/1Capsule, Liquid filledOralWALMART INC.79903-02079903-0020-22
SimethiconeDimethicone 250 mg/1Capsule, Liquid filledOralWALGREEN CO.0363-994500363-9945-02
SimethiconeDimethicone 180 mg/1Capsule, Liquid filledOralHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd53345-03653345-0036-01
SimethiconeDimethicone 250 mg/1Capsule, Liquid filledOralHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd53345-03253345-0032-02

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
ProductStrengthForm · routeLabelerProduct NDC
Extra Strength Gas Relief CherrysimethiconeDimethicone 125 mg/1Tablet, ChewableOralHarris Teeter, LLC69256-134
Gas Relief Extra StrengthsimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralCardinal Health (Leader) 7000070000-0529
Extra Strength Gas ReliefsimethiconeDimethicone, Unspecified 125 mg/1Tablet, ChewableOralSAFEWAY21130-110
Simethicone 250mgDimethicone 250 mg/1Capsule, Liquid filledOralAMZ789 LLC73629-006
FEVIA Gas ControlsimethiconeDimethicone, Unspecified 250 mg/1Capsule, Liquid filledOralVIVUNT PHARMA LLC82706-031
Mylicon Infants Gas Relief OriginalsimethiconeDimethicone 20 mg/.3mLEmulsionOralInfirst Healthcare62372-630
SimethiconeDimethicone 180 mg/1Capsule, Liquid filledOralAMZ789 LLC73629-002
CVS PHARMACY Gas reliefsimethiconeDimethicone, Unspecified 80 mg/1Tablet, ChewableOralCVS51316-111
Curist Gas ReliefsimethiconeDimethicone 180 mg/180mgCapsule, Liquid filledOralLittle Pharma. Inc.72559-041
Gas ReliefsimethiconeDimethicone 125 mg/1Tablet, ChewableOralChain Drug Marketing Association, Inc.83324-325
Gas ReliefsimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralFamily Dollar (FAMILY WELLNESS)55319-555
Gas Relief Extra StrengthsimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralCare One (Retail Business Services, LLC.)72476-897
Curist Gas ReliefsimethiconeDimethicone 250 mg/250mgCapsule, Liquid filledOralLittle Pharma. Inc.72559-042
mylanta gassimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralInfirst Healthcare62372-554
Ultra Strength Gas ReliefsimethiconeDimethicone 180 mg/1CapsuleOralBETTER LIVING BRANDS, LLC21130-717
SimethiconeDimethicone 80 mg/1Tablet, ChewableOralAphena Pharma Solutions - Tennessee, LLC71610-649
FEVIA Gas ControlsimethiconeDimethicone, Unspecified 250 mg/1Capsule, Liquid filledOralVIVUNT PHARMA LLC82706-031
Mylicon Infants Gas Relief Dye FreesimethiconeDimethicone 20 mg/.3mLEmulsionOralInfirst Healthcare62372-650
QUITA COLICOS Gas RELIEF DropssimethiconeDimethicone 20 mg/.3mLLiquidOralDLC Laboratories, Inc.24286-1533
AntiflatulentsimethiconeDimethicone 80 mg/1Tablet, ChewableOralAphena Pharma Solutions - Tennessee, LLC71610-650

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