What is NDC 71610-649?

71610-649 is the product NDC for Simethicone, Dimethicone 80 mg/1 tablet, chewable, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-649 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-649Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0649Add 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
71610-649-04	7161006490471610064904	4 TABLET, CHEWABLE in 1 BOTTLE (71610-649-04)Marketed from May 19, 2022

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 — 80 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 002
Marketing start: Jan 1, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Skin Barrier Activity (Physiologic effect)
Identifiers: Product ID 71610-649_2b5afc84-182d-07ef-e063-6294a90a9f3eSPL ID 2b5afc84-182d-07ef-e063-6294a90a9f3eSPL set ID 5df94be7-0bc9-4be1-9982-8193e3a3c8efRxCUI 314216UNII 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

N471610064904 followed by a unit qualifier and the quantity

Package 71610-0649-04. 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 Jan 10, 2025.

Indications (excerpt from the label)

Uses relieves 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 71610-649

What is NDC 71610-649?: 71610-649 is the product NDC for Simethicone, Dimethicone 80 mg/1 tablet, chewable, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 250 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	53345-032	53345-0032-02

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
Product	Strength	Form · route	Labeler	Product NDC
Extra Strength Gas Relief Cherrysimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Harris Teeter, LLC	69256-134
Gas Relief Extra Strengthsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Cardinal Health (Leader) 70000	70000-0529
Extra Strength Gas Reliefsimethicone	Dimethicone, Unspecified 125 mg/1	Tablet, ChewableOral	SAFEWAY	21130-110
Simethicone 250mg	Dimethicone 250 mg/1	Capsule, Liquid filledOral	AMZ789 LLC	73629-006
FEVIA Gas Controlsimethicone	Dimethicone, Unspecified 250 mg/1	Capsule, Liquid filledOral	VIVUNT PHARMA LLC	82706-031
Mylicon Infants Gas Relief Originalsimethicone	Dimethicone 20 mg/.3mL	EmulsionOral	Infirst Healthcare	62372-630
Simethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	AMZ789 LLC	73629-002
CVS PHARMACY Gas reliefsimethicone	Dimethicone, Unspecified 80 mg/1	Tablet, ChewableOral	CVS	51316-111
Curist Gas Reliefsimethicone	Dimethicone 180 mg/180mg	Capsule, Liquid filledOral	Little Pharma. Inc.	72559-041
Gas Reliefsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Chain Drug Marketing Association, Inc.	83324-325
Gas Reliefsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Family Dollar (FAMILY WELLNESS)	55319-555
Gas Relief Extra Strengthsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Care One (Retail Business Services, LLC.)	72476-897
Curist Gas Reliefsimethicone	Dimethicone 250 mg/250mg	Capsule, Liquid filledOral	Little Pharma. Inc.	72559-042
mylanta gassimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Infirst Healthcare	62372-554
Ultra Strength Gas Reliefsimethicone	Dimethicone 180 mg/1	CapsuleOral	BETTER LIVING BRANDS, LLC	21130-717
FEVIA Gas Controlsimethicone	Dimethicone, Unspecified 250 mg/1	Capsule, Liquid filledOral	VIVUNT PHARMA LLC	82706-031
Mylicon Infants Gas Relief Dye Freesimethicone	Dimethicone 20 mg/.3mL	EmulsionOral	Infirst Healthcare	62372-650
QUITA COLICOS Gas RELIEF Dropssimethicone	Dimethicone 20 mg/.3mL	LiquidOral	DLC Laboratories, Inc.	24286-1533
Antiflatulentsimethicone	Dimethicone 80 mg/1	Tablet, ChewableOral	Aphena Pharma Solutions - Tennessee, LLC	71610-650
Mylanta Gas Minis Mint Flavorsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Infirst Healthcare Inc.	62372-800

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