Over-the-counter drug · OTC MONOGRAPH DRUG
Simethicone 80 mg (Simethicone) NDC 82804-043
Dimethicone 80 mg/1 · Tablet, Chewable · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-043-30 | 8280400433082804004330 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-30)Marketed from Nov 16, 2023 | |
| 82804-043-60 | 8280400436082804004360 | 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-60)Marketed from Nov 16, 2023 | |
| 82804-043-90 | 8280400439082804004390 | 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-90)Marketed from Nov 16, 2023 |
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 80 mg
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone — 80 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 82804-043_c27c3d6a-64ca-47d4-bba6-a0c5288e755bSPL ID c27c3d6a-64ca-47d4-bba6-a0c5288e755bSPL set ID a5e523b3-475e-4d28-a89c-c4325c59c939RxCUI 314216UNII 92RU3N3Y1OUPC 0382804043309
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
N482804004330followed by a unit qualifier and the quantityPackage 82804-0043-30. 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 82804-043
- What is NDC 82804-043?
- 82804-043 is the product NDC for Simethicone 80 mg (simethicone), Dimethicone 80 mg/1 tablet, chewable, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simethicone 80 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 80 mg?
- 1 other product NDC are listed under this name. See all Simethicone 80 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 80 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 80 mgsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Reliable 1 Laboratories LLC | 69618-033 | 69618-0033-01 |
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 |
|---|---|---|---|---|
| Extra Strength Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Harris Teeter, LLC | 69256-135 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Cardinal Health (Leader) 70000 | 70000-0529 |
| Extra Strength Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Geri-Care Pharmaceuticals, Corp | 57896-694 |
| QUITA COLICOS Gas RELIEF Dropssimethicone | Dimethicone 20 mg/.3mL | LiquidOral | DLC Laboratories, Inc. | 24286-1533 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-897 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-8730 |
| gas reliefsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | GLENMARK THERAPEUTICS INC., USA | 72657-482 |
| Simethicone | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | WALGREEN CO. | 0363-9945 |
| gas reliefsimethicone | Dimethicone, Unspecified 125 mg/1 | Capsule, Liquid filledOral | GLENMARK THERAPEUTICS INC., USA | 72657-480 |
| Target Gas Relief Chews Mixed Berry and Strawberrysimethicone | Dimethicone 250 mg/1; Calcium carbonate 750 mg/1 | Tablet, ChewableOral | Target | 11673-548 |
| Ultra Strength Gas Reliefsimethicone | Dimethicone 180 mg/1 | CapsuleOral | BETTER LIVING BRANDS, LLC | 21130-717 |
| Simethicone 80Mgsimethicone | Dimethicone, Unspecified 80 mg/1 | Tablet, ChewableOral | Cardinal Health 107, LLC | 55154-2606 |
| gas reliefsimethicone | Dimethicone, Unspecified 180 mg/1 | Capsule, Liquid filledOral | GLENMARK THERAPEUTICS INC., USA | 72657-481 |
| extra strength Gas Relief cherry cremesimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Amerisource Bergen | 46122-811 |
| Alcohol prep pad | Isopropyl alcohol 70 g/1001 | ClothTopical | Target Corporation | 11673-139 |
| Maximum Strength Gas Reliefsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | Chain Drug Marketing Association, Inc. | 63868-975 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Rite Aid Corporation | 11822-6080 |
| simethicone gas reliefsimethicone | Dimethicone 20 mg/.3mL | Suspension/ dropsOral | MOM Enterprises, LCC | 71444-788 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Chain Drug Marketing Association, Inc. | 83324-325 |
| Antiflatulentsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Major Pharmaceuticals | 0904-7206 |
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