Over-the-counter drug · ANDA
Anti-Diarrheal (Loperamide hcl) NDC 80136-063
Loperamide hydrochloride 2 mg/1 · Tablet · Oral · Heartland Pharma Co.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)80136-063Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80136-0063Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80136-063-11 | 8013600631180136006311 | 4 BLISTER PACK in 1 CARTON (80136-063-11) / 6 TABLET in 1 BLISTER PACKMarketed from Jan 22, 2021 |
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
- Heartland Pharma Co.NDC labeler code 80136
- 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 80136-063_6ceb12f5-6d8d-4a45-a7cb-fa8ad0f10fecSPL ID 6ceb12f5-6d8d-4a45-a7cb-fa8ad0f10fecSPL set ID e360ba61-556a-4d7f-ab2e-2cb71656d868RxCUI 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
N480136006311followed by a unit qualifier and the quantityPackage 80136-0063-11. 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 80136-063
- What is NDC 80136-063?
- 80136-063 is the product NDC for Anti-Diarrheal (loperamide hcl), Loperamide hydrochloride 2 mg/1 tablet, listed with the FDA by Heartland Pharma Co.. 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?
- Heartland Pharma Co., NDC labeler code 80136. 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 hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Advanced Rx LLC | 80513-375 | 80513-0375-08 |
| 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 |
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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