Over-the-counter drug · ANDA
Loperamide Hydrochloride and Simethicone NDC 84441-713
Dimethicone 125 mg/1; Loperamide hydrochloride 2 mg/1 · Tablet · Oral · IMO-GEN LABS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84441-713-10 | 84441071310 | 100 TABLET in 1 BOTTLE (84441-713-10)Marketed from Oct 23, 2025 |
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 Hydrochloride and Simethicone
- Generic name (nonproprietary)
- loperamide hydrochloride and simethicone
- Active ingredients
- Dimethicone — 125 mg/1Loperamide hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- IMO-GEN LABS LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211438
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 84441-713_41d6dba5-e412-c8d2-e063-6294a90ae8faSPL ID 41d6dba5-e412-c8d2-e063-6294a90ae8faSPL set ID 41d6dba5-e411-c8d2-e063-6294a90ae8faRxCUI 978001UNII 92RU3N3Y1O, 77TI35393CUPC 0860010278123
- 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
N484441071310followed by a unit qualifier and the quantityPackage 84441-0713-10. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
USE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211438
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 |
|---|---|---|---|---|
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | FSA store INC | 81522-325 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Camber Consumer Care Inc | 69230-325 |