Over-the-counter drug · ANDA
Anti-Diarrheal (Loperamide hcl) NDC 80513-375
Loperamide hydrochloride 2 mg/1 · Tablet · Oral · Advanced Rx LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)80513-375Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80513-0375Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80513-375-08 | 8051303750880513037508 | 4 BLISTER PACK in 1 CARTON (80513-375-08) / 6 TABLET in 1 BLISTER PACKMarketed from Jan 3, 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)
- Anti-Diarrheal
- Generic name (nonproprietary)
- loperamide hcl
- Active ingredients
- Loperamide hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx LLCNDC labeler code 80513
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076497
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 80513-375_84cde7cf-6628-45b6-9673-16ffef460a4cSPL ID 84cde7cf-6628-45b6-9673-16ffef460a4cSPL set ID 148cb6b7-28e7-48e9-b464-f42daa90e5daRxCUI 978010UNII 77TI35393CUPC 0380513001030
- 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
N480513037508followed by a unit qualifier and the quantityPackage 80513-0375-08. 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 80513-375
- What is NDC 80513-375?
- 80513-375 is the product NDC for Anti-Diarrheal (loperamide hcl), Loperamide hydrochloride 2 mg/1 tablet, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Anti-Diarrheal (Loperamide HCl).
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Anti-Diarrheal?
- 73 other product NDCs are listed under this name. See all 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 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) |
|---|---|---|---|---|---|
| Anti-Diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Kroger | 41226-797 | 41226-0797-2241226-0797-24 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, CoatedOral | Grocery Outlet | 85828-248 | 85828-0248-93 |
| Anti-Diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | CHAIN DRUG MARKETING ASSOCIATION INC. | 83324-208 | 83324-0208-12 |
| Anti-Diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | CHAIN DRUG MARKETING ASSOCIATION INC. | 83324-209 | 83324-0209-24 |
| anti-diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | Albertsons Companies | 21130-835 | 21130-0835-12 |
| anti-diarrhealloperamide hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Safeway | 21130-381 | 21130-0381-34 |
| anti-diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | PUBLIX SUPER MARKETS INC | 56062-680 | 56062-0680-12 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Chain Drug Marketing Association, Inc. | 83324-064 | 83324-0064-1283324-0064-24 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Yyba Corp | 73581-171 | 73581-0171-24 |
| anti-diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-313 | 72288-0313-12 |
Other NDCs under ANDA 076497
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 |
|---|---|---|---|---|
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | CapsuleOral | WinCo Foods | 67091-405 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Valu Merchandisers Company | 63941-375 |
| Anti-Diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | IMO-GEN LABS LLC | 84441-711 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-559 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, CoatedOral | First Aid Direct | 53117-248 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-375 |
| Anti-Diarrhealmarc glassman | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Marc Glassman, Inc. | 68998-248 |
| First Aid Direct Anti-Diarrheal | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Cintas Corp | 42961-103 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Kroger Company | 30142-775 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | H E B | 37808-375 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Family Dollar Services Inc | 55319-375 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Redpharm Drug | 67296-2314 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Discount Drug Mart | 53943-375 |
| Anti-diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | BI-MART | 37835-131 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Geri-Care Pharmaceutical Corp | 57896-381 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Walgreen Company | 0363-0375 |
| Anti-Diarrheal, 24/7 Life by 7-Elevenloperamide hcl tablet | Loperamide hydrochloride 2 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 66715-4644 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Rite Aid Corporation | 11822-0375 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, CoatedOral | Grocery Outlet | 85828-248 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | DOLGENCORP, LLC | 55910-375 |
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