Over-the-counter drug · OTC MONOGRAPH DRUG
Simethicone 125 mg (Simethicone) NDC 82804-152
Dimethicone 125 mg/1 · Tablet, Chewable · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-152-09 | 8280401520982804015209 | 9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-152-09)Marketed from Sep 25, 2024 |
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 125 mg
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone — 125 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-152_078ef54e-96b2-4e2f-bebc-9b9bcda1f90aSPL ID 078ef54e-96b2-4e2f-bebc-9b9bcda1f90aSPL set ID 078ef54e-96b2-4e2f-bebc-9b9bcda1f90aRxCUI 314221UNII 92RU3N3Y1OUPC 0382804152094
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
N482804015209followed by a unit qualifier and the quantityPackage 82804-0152-09. 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)
Use relieves bloating, pressure and fullness commonly referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 82804-152
- What is NDC 82804-152?
- 82804-152 is the product NDC for Simethicone 125 mg (simethicone), Dimethicone 125 mg/1 tablet, chewable, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simethicone 125 mg (Simethicone).
- What is the active ingredient?
- Dimethicone.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. 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 125 mg?
- 3 other product NDCs are listed under this name. See all Simethicone 125 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Simethicone 125 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Simethicone 125 mgsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | ATLANTIC BIOLOGICALS CORP. | 17856-0137 | 17856-0137-0117856-0137-02 |
| Simethicone 125 mgsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Reliable 1 Laboratires LLC | 69618-032 | 69618-0032-06 |
| Simethicone 125 mgsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Sportpharm LLC | 85766-302 | 85766-0302-3085766-0302-6085766-0302-90 |
Other NDCs under M 002
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 |
| 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 |
| Gas-Aid Drops for infantssimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Leosons Overseas Corp | 69626-5200 |
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