Over-the-counter drug · OTC MONOGRAPH DRUG
Antiflatulent (Simethicone) NDC 71610-650
Dimethicone 80 mg/1 · Tablet, Chewable · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-650-04 | 71610065004 | 4 TABLET, CHEWABLE in 1 BOTTLE (71610-650-04)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)
- Antiflatulent
- 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
- Listing expires
- Other FDA classes
- Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 71610-650_2b5b34d8-29c2-fc54-e063-6394a90aaa7aSPL ID 2b5b34d8-29c2-fc54-e063-6394a90aaa7aSPL set ID dd2ca97e-89eb-4940-ac6e-abf1f9e1c6eaRxCUI 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
N471610065004followed by a unit qualifier and the quantityPackage 71610-0650-04. 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 .
Indications (excerpt from the label)
USE(S) relieves: pressure bloating symptoms referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 71610-650
- What is NDC 71610-650?
- 71610-650 is the product NDC for Antiflatulent (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?
- Antiflatulent (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 Antiflatulent?
- 1 other product NDC are listed under this name. See all Antiflatulent NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Antiflatulent products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Antiflatulentsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Major Pharmaceuticals | 0904-7206 | 00904-7206-60 |
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 |
|---|---|---|---|---|
| Alcohol prep pad | Isopropyl alcohol 70 g/1001 | ClothTopical | Target Corporation | 11673-139 |
| Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone | Aluminum hydroxide 400 mg/5mL + 2 more ingredients | SuspensionOral | American Health Packaging | 60687-888 |
| Amazon Extra Strengthsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | AMAZON.COM SERVICES LLC | 72288-101 |
| Antacid Antigasaluminum hydroxide, magnesium hydroxide, simethicone | Aluminum hydroxide 400 mg/10mL + 2 more ingredients | LiquidOral | Retail Business Services, LLC. | 72476-503 |
| Anti-Gassimethicone | Dimethicone 125 mg/1 | CapsuleOral | Marc Glassman, Inc. | 68998-419 |
| Anti-Gassimethicone | Dimethicone 125 mg/1 | CapsuleOral | Allegiant Health | 69168-419 |
| Anti-Gas Stripsimethicone | Dimethicone 62.5 mg/1 | StripOral | Calmour | 82918-001 |
| Anti-Gas Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-773 |
| Antiflatulentsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Major Pharmaceuticals | 0904-7206 |
| basic care gas reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-428 |
| basic care gas reliefsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-657 |
| Best Choicesimethicone | Dimethicone, Unspecified 20 mg/.3mL | Suspension/ dropsOral | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 63941-709 |
| Best Choice Extra Strengthsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 63941-110 |
| Cardinal Health Infants Gas Reliefsimethicone | Dimethicone, Unspecified 20 mg/.3mL | Suspension/ dropsOral | CARDINAL HEALTH | 70000-0051 |
| Care One Gas Reliefsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | American Sales Company | 41520-657 |
| Childrens Emetrol Multi Symptom Upset Stomach Reliefchildrens emetrol multi-symptom upset stomach relief | Calcium cation 400 mg/1; Dimethicone 40 mg/1 | Tablet, ChewableOral | WellSpring Pharmaceutical Corporation | 65197-230 |
| Childrens Mylicon All in One Tummy Relief for Kidsantacid and antigas | Calcium carbonate 400 mg/5mL; Dimethicone 40 mg/5mL | LiquidOral | Infirst Healthcare Inc. | 62372-410 |
| Childrens Mylicon Tummy Relief for Kidsantacid and antigas | Calcium carbonate 400 mg/1; Dimethicone 40 mg/1 | Tablet, ChewableOral | Infirst Healthcare Inc. | 62372-400 |
| Childrens Simethicone Drops | Dimethicone 40 mg/.6mL | LiquidOral | PAI Holdings, LLC dba PAI Pharma | 0121-1095 |
| Curist Gas Reliefsimethicone | Dimethicone 180 mg/180mg | Capsule, Liquid filledOral | Little Pharma. Inc. | 72559-041 |
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