Over-the-counter drug · ANDA
CareOne Diarrhea Control (Loperamide hydrochloride) NDC 41520-841
Loperamide hydrochloride 1 mg/7.5mL · Suspension · Oral · American Sales Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-841-26 | 4152008412641520084126 | 120 mL in 1 BOTTLE (41520-841-26)Marketed from Nov 23, 2016 |
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)
- CareOne Diarrhea Control
- Generic name (nonproprietary)
- loperamide hydrochloride
- Active ingredients
- Loperamide hydrochloride — 1 mg/7.5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- American Sales CompanyNDC labeler code 41520
- 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 41520-841_073b5ad8-c4b0-4a3b-bf58-c4b6ab14af0aSPL ID 073b5ad8-c4b0-4a3b-bf58-c4b6ab14af0aSPL set ID 95ba9c92-77f5-4344-a4f3-78eda9ebc823RxCUI 1250685UNII 77TI35393C
- 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
N441520084126followed by a unit qualifier and the quantityPackage 41520-0841-26. 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.
About NDC 41520-841
- What is NDC 41520-841?
- 41520-841 is the product NDC for CareOne Diarrhea Control (loperamide hydrochloride), Loperamide hydrochloride 1 mg/7.5mL suspension, listed with the FDA by American Sales Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CareOne Diarrhea Control (Loperamide Hydrochloride).
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CareOne Diarrhea Control?
- 1 other product NDC are listed under this name. See all CareOne Diarrhea Control NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CareOne Diarrhea Control products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| CareOne Diarrhea Controlloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-813 | 41520-0813-5341520-0813-62 |
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 |
|---|---|---|---|---|
| basic care loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Amazon.com Services LLC | 72288-645 |
| 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 | Major Pharmaceuticals | 0904-6836 |
| Equate Loperamide Hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-451 |
| basic care loperamide hydrochlorideloperamide hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Amazon.com Services LLC | 72288-758 |
| 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 | Meijer Distribution Inc | 41250-813 |
| Loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | CVS Pharmacy | 69842-191 |
| loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-7842 |
| leader anti diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Cardinal Health 110, LLC. dba Leader | 70000-0417 |
| Loperamide Hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Precision Dose, Inc. | 68094-029 |
| leader anti diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Cardinal Health 110, LLC. dba Leader | 70000-0418 |
| topcare loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Topco Associates LLC | 36800-583 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | H E B | 37808-449 |
| DG Health Anti Diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Dolgencorp Inc | 55910-867 |
| Loperamide Hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Precision Dose, Inc. | 68094-129 |
| 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 |
| equate diarrhea controlloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-695 |
| Good Sense antidiarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8796 |
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