Over-the-counter drug · ANDA
leader anti diarrheal (Loperamide hcl) NDC 70000-0417
Loperamide hydrochloride 1 mg/7.5mL · Solution · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70000-0417Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0417Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0417-1 | 7000004170170000041701 | 120 mL in 1 BOTTLE (70000-0417-1)Marketed from Jul 16, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- leader anti diarrheal
- Generic name (nonproprietary)
- loperamide hcl
- Active ingredients
- Loperamide hydrochloride — 1 mg/7.5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
- 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 70000-0417_0e8c379f-d704-46b4-8297-fb995e0171ecSPL ID 0e8c379f-d704-46b4-8297-fb995e0171ecSPL set ID c27e6fbd-8822-4784-9d24-497ae78e54f4RxCUI 1250685UNII 77TI35393CUPC 0096295135428
- 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
N470000041701followed by a unit qualifier and the quantityPackage 70000-0417-01. 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 70000-0417
- What is NDC 70000-0417?
- 70000-0417 is the product NDC for leader anti diarrheal (loperamide hcl), Loperamide hydrochloride 1 mg/7.5mL solution, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- leader anti diarrheal (Loperamide HCl).
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for leader anti diarrheal?
- 3 other product NDCs are listed under this name. See all leader anti diarrheal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other leader anti diarrheal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| leader anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0589 | 70000-0589-01 |
| leader anti diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Cardinal Health 110, LLC. dba Leader | 70000-0418 | 70000-0418-01 |
| Leader Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0225 | 70000-0225-02 |
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 |
| 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 |
| CareOne Diarrhea Controlloperamide hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | American Sales Company | 41520-841 |
| 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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