What is NDC 68016-811?

68016-811 is the product NDC for Premier Value Extra Strength (simethicone), Dimethicone, Unspecified 125 mg/1 tablet, chewable, listed with the FDA by PHARMACY VALUE ALLIANCE, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Premier Value Extra Strength (Simethicone).

PHARMACY VALUE ALLIANCE, LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Premier Value Extra Strength?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Premier Value Extra Strength NDC 68016-811

NDC codes

FDA NDC Directory

Product NDC (as listed)68016-811Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68016-0811Add 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
68016-811-18	6801608111868016081118	2 BLISTER PACK in 1 CARTON (68016-811-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from May 15, 2019

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): Premier Value Extra StrengthSuffix: Extra Strength
Generic name (nonproprietary): simethicone
Active ingredients: Dimethicone, Unspecified — 125 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: PHARMACY VALUE ALLIANCE, LLCNDC labeler code 68016
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 002
Marketing start: May 15, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Skin Barrier Activity (Physiologic effect)
Identifiers: Product ID 68016-811_a73731e6-56d7-43a9-8623-dc9859be4f38SPL ID a73731e6-56d7-43a9-8623-dc9859be4f38SPL set ID df2b1b62-5bd2-4d02-86c2-537b965a8d20RxCUI 314221UNII 92RU3N3Y1OUPC 0840986019197

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

N468016081118 followed by a unit qualifier and the quantity

Package 68016-0811-18. 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 Oct 28, 2024.

Indications (excerpt from the label)

Uses For the 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 68016-811

What is NDC 68016-811?: 68016-811 is the product NDC for Premier Value Extra Strength (simethicone), Dimethicone, Unspecified 125 mg/1 tablet, chewable, listed with the FDA by PHARMACY VALUE ALLIANCE, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Premier Value Extra Strength (Simethicone).
What is the active ingredient?: Dimethicone, Unspecified.
Who is the labeler?: PHARMACY VALUE ALLIANCE, LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Premier Value Extra Strength?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Simethicone	Dimethicone 80 mg/1	Tablet, ChewableOral	Aphena Pharma Solutions - Tennessee, LLC	71610-649
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

Showing 20 of 40.

Premier Value Extra Strength (Simethicone) NDC 68016-811