Over-the-counter drug · ANDA
topcare loperamide hydrochloride (loperamide hcl) NDC 36800-583
Loperamide hydrochloride 1 mg/7.5mL · Solution · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-583-26 | 36800058326 | 120 mL in 1 BOTTLE (36800-583-26)Marketed from Sep 12, 2018 | |
| 36800-583-34 | 36800058334 | 240 mL in 1 BOTTLE (36800-583-34)Marketed from Sep 16, 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)
- topcare loperamide hydrochloride
- Generic name (nonproprietary)
- loperamide hcl
- Active ingredients
- Loperamide hydrochloride — 1 mg/7.5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Topco Associates LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091292
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 36800-583_dc29e904-1358-4d41-8eed-d83136200862SPL ID dc29e904-1358-4d41-8eed-d83136200862SPL set ID 1cd497b4-d97e-447a-9251-710d2fddbf23RxCUI 1250685UNII 77TI35393CUPC 0036800367531
- 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
N436800058326followed by a unit qualifier and the quantityPackage 36800-0583-26. 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 controls symptoms of diarrhea, including Travelers’ Diarrhea
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091292
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 hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Major Pharmaceuticals | 0904-6836 |
| basic care loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Amazon.com Services LLC | 72288-645 |
| Good Sense antidiarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | L. Perrigo Company | 0113-1645 |
| Good Sense antidiarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8796 |
| loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-6836 |
| Loperamide Hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Amazon.com Services LLC | 72288-048 |
| loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Meijer Distribution Inc | 41250-813 |
| equate diarrhea controlloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-695 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | H E B | 37808-449 |
| basic care loperamide hydrochlorideloperamide hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Amazon.com Services LLC | 72288-758 |
| equaline loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | United Natural Foods, Inc. dba UNFI | 41163-210 |
| loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Rite Aid Corporation | 11822-5519 |
| CareOne Diarrhea Controlloperamide hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | American Sales Company | 41520-841 |
| foster and thrive anti-diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Strategic Sourcing Services LLC | 70677-1107 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Walgreen Company | 0363-2022 |
| Up and Up anti diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Target Corporation | 11673-900 |
| good neighbor pharmacy loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Amerisource Bergen | 46122-544 |
| Loperamide Hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Precision Dose, Inc. | 68094-029 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Kroger Company | 30142-514 |
| Loperamide Hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Precision Dose, Inc. | 68094-129 |
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