Over-the-counter drug · ANDA
berkley and jensen anti diarrheal NDC 68391-224
loperamide hydrochloride · Loperamide hydrochloride 2 mg/1 · Tablet, Film coated · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-224-62 | 68391022462 | 24 BLISTER PACK in 1 CARTON (68391-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 15, 2020 |
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)
- berkley and jensen anti diarrheal
- Generic name (nonproprietary)
- loperamide hydrochloride
- Active ingredients
- Loperamide hydrochloride — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- BJWC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075232
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68391-224_16e8ebf2-bc1d-4930-9fd4-37258bfeaa6fSPL ID 16e8ebf2-bc1d-4930-9fd4-37258bfeaa6fSPL set ID dc29a8e9-f916-49d2-b9a6-d2b4537d7b58RxCUI 978010UNII 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
N468391022462followed by a unit qualifier and the quantityPackage 68391-0224-62. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 075232
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 |
|---|---|---|---|---|
| Up and Up anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-224 |
| Imodium A-Dloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-317 |
| Good Sense anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-079 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-224 |
| leader anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0589 |
| CareOne Diarrhea Controlloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-813 |
| foster and thrive anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1106 |
| Good Sense anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0224 |
| Good Sense anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-663 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-224 |
| basic care loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-224 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | H E B | 37808-552 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7725 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-700 |
| topcare anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-224 |
| Leader Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0225 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Redpharm Drug Inc | 67296-1472 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1010 |
| dg health anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Dolgencorp, LLC | 55910-224 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-960 |
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