Over-the-counter drug · ANDA
Anti-Diarrheal (loperamide hcl) NDC 55319-375
Loperamide hydrochloride 2 mg/1 · Tablet · Oral · Family Dollar Services Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55319-375-08 | 55319037508 | 4 BLISTER PACK in 1 CARTON (55319-375-08) / 6 TABLET in 1 BLISTER PACKMarketed from May 3, 2005 | |
| 55319-375-12 | 55319037512 | 2 BLISTER PACK in 1 CARTON (55319-375-12) / 6 TABLET in 1 BLISTER PACKMarketed from May 3, 2005 |
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
- Family Dollar Services Inc
- 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 55319-375_272ad7f5-16d2-45d8-ad00-bfb703987ec0SPL ID 272ad7f5-16d2-45d8-ad00-bfb703987ec0SPL set ID 769e7182-fa11-4645-8fca-657253f28d9cRxCUI 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
N455319037508followed by a unit qualifier and the quantityPackage 55319-0375-08. 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.
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 | TabletOral | H E B | 37808-375 |
| 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 | ARMY AND AIR FORCE EXCHANGE SERVICE | 55301-375 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | DOLGENCORP, LLC | 55910-375 |
| First Aid Direct Anti-Diarrheal | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Cintas Corp | 42961-103 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Advanced Rx LLC | 80513-375 |
| Anti-Diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | Advanced Rx LLC | 80513-401 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Kroger Company | 30142-775 |
| Anti-diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Chain Drug Consortium | 68016-301 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Heartland Pharma Co. | 80136-063 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, CoatedOral | Allegiant Health | 69168-248 |
| Anti-diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | BI-MART | 37835-131 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | L.N.K. International, Inc. | 50844-259 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Rite Aid Corporation | 11822-0375 |
| Anti-diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | L.N.K. International, Inc. | 50844-375 |
| Loperamide HCl | Loperamide hydrochloride 2 mg/1 | TabletOral | L.N.K. International, Inc. | 50844-735 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | WinCo Foods, LLC | 67091-335 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Chain Drug Marketing Association, Inc. | 83324-064 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-375 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, CoatedOral | First Aid Direct | 53117-248 |
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