Over-the-counter drug · ANDA
Loperamide HCl and Simethicone NDC 51660-069
Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 · Tablet · Oral · Ohm Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51660-069-06 | 51660006906 | 6 TABLET in 1 BLISTER PACK (51660-069-06)Marketed from Jan 13, 2022 | |
| 51660-069-12 | 51660006912 | 2 BLISTER PACK in 1 CARTON (51660-069-12) / 6 TABLET in 1 BLISTER PACKMarketed from Jan 13, 2022 | |
| 51660-069-18 | 51660006918 | 3 BLISTER PACK in 1 CARTON (51660-069-18) / 6 TABLET in 1 BLISTER PACKMarketed from Jan 13, 2022 | |
| 51660-069-24 | 51660006924 | 4 BLISTER PACK in 1 CARTON (51660-069-24) / 6 TABLET in 1 BLISTER PACKMarketed from Jan 13, 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)
- Loperamide HCl and Simethicone
- Generic name (nonproprietary)
- loperamide hcl and simethicone
- Active ingredients
- Loperamide hydrochloride — 2 mg/1Dimethicone — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ohm Laboratories Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077500
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 51660-069_86ddd92a-920c-40b8-b0bd-29bfb3b38bfcSPL ID 86ddd92a-920c-40b8-b0bd-29bfb3b38bfcSPL set ID 06f99f59-e702-49f1-bb1d-e7cf58c54c30RxCUI 978001UNII 77TI35393C, 92RU3N3Y1O
- Pharmacologic class
- Opioid Agonist
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
N451660006906followed by a unit qualifier and the quantityPackage 51660-0069-06. 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)
Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Excerpt only. Read the full label for complete information.