Over-the-counter drug · OTC MONOGRAPH DRUG
Simethicone 80Mg (Simethicone) NDC 77333-812
Dimethicone 80 mg/1 · Tablet, Chewable · Oral · Gendose Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 77333-812-10 | 7733308121077333081210 | 100 BLISTER PACK in 1 BOX (77333-812-10) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (77333-812-25)Marketed from Oct 15, 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 80Mg
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone — 80 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Gendose Pharmaceuticals, LLCNDC labeler code 77333
- 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 77333-812_5d28be40-5dcf-23ca-e063-6294a90ace72SPL ID 5d28be40-5dcf-23ca-e063-6294a90ace72
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
N477333081210followed by a unit qualifier and the quantityPackage 77333-0812-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 77333-812
- What is NDC 77333-812?
- 77333-812 is the product NDC for Simethicone 80Mg (simethicone), Dimethicone 80 mg/1 tablet, chewable, listed with the FDA by Gendose Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simethicone 80Mg (Simethicone).
- What is the active ingredient?
- Dimethicone.
- Who is the labeler?
- Gendose Pharmaceuticals, LLC, NDC labeler code 77333. 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 80Mg?
- 1 other product NDC are listed under this name. See all Simethicone 80Mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Simethicone 80Mg 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 80Mgsimethicone | Dimethicone, Unspecified 80 mg/1 | Tablet, ChewableOral | Cardinal Health 107, LLC | 55154-2606 | 55154-2606-00 |
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 |
|---|---|---|---|---|
| Gas-X Ultimate Strength Softgelssimethicone | Dimethicone, Unspecified 500 mg/1 | Capsule, Liquid filledOral | Haleon US Holdings LLC | 0067-8075 |
| Pepto Gas plus Bloatingsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | The Procter & Gamble Manufacturing Company | 84126-378 |
| Equaline Stomach Reliefbismuth subsalicylate | Bismuth subsalicylate 262 mg/1 | Tablet, ChewableOral | UNITED NATURAL FOODS, INC. DBA UNFI | 41163-058 |
| Infants Gas Relief Dropssimethicone | Dimethicone, Unspecified 20 mg/.3mL | EmulsionOral | DOLGENCORP INC | 55910-790 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Walgreen Co. | 0363-9938 |
| Gas Relief Simethicone 180mg Softgelsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | NUVICARE LLC | 84324-015 |
| Quality Choice Gas Relief Extra Strength Softgelssimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Chain Drug Marketing Association | 83324-196 |
| ULTRA STRENGTH Gas Relief Softgelssimethicone | Dimethicone, Unspecified 180 mg/1 | Capsule, Liquid filledOral | Topco Associates LLC | 76162-840 |
| HEB Anti Gas Extra Strengthsimethicone | Dimethicone, Unspecified 125 mg/1 | Capsule, Liquid filledOral | HEB | 37808-231 |
| Gencare-Gas Reliefsimethicone 180 mg | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | PIONEER LIFE SCIENCES, LLC | 72090-073 |
| Infantssimethicone | Dimethicone 20 mg/.3mL | Suspension/ dropsOral | ATLANTIC BIOLOGICALS CORP. | 17856-1303 |
| Gas-Aid Drops for infantssimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Leosons Overseas Corp | 69626-5200 |
| Extra Strength Gas Reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0118 |
| Gas-Aidsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Leosons Overseas Corp | 69626-7197 |
| Gas Reliefsimethicone 125 mg | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | NUVICARE LLC | 84324-022 |
| GNP Pink Bismuthbismuth subsalicylate | Bismuth subsalicylate 262 mg/1 | Tablet, ChewableOral | Amerisource Bergen | 46122-701 |
| Walgreens Extra Strengthsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | WALGREENS CO. | 0363-0118 |
| WinCo Foods Gas Relief Extra Strength Softgelssimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | WinCo Foods, LLC | 67091-379 |
| Quality Choice Gas Relief Extra Strength Softgelssimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Chain Drug Marketing Association | 63868-586 |
| GNP Stomach Reliefbismuth subsalicylate 525 mg | Bismuth subsalicylate 525 mg/30mL | LiquidOral | Amerisource Bergen | 46122-703 |
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