Over-the-counter drug · ANDA
Imodium A-D (Loperamide hydrochloride) NDC 50580-317
Loperamide hydrochloride 2 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)50580-317Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0317Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-317-01 | 5058003170150580031701 | 1 BLISTER PACK in 1 CARTON (50580-317-01) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 13, 2015 | |
| 50580-317-03 | 5058003170350580031703 | 4 BLISTER PACK in 1 CARTON (50580-317-03) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 13, 2015 | |
| 50580-317-06 | 5058003170650580031706 | 2 BLISTER PACK in 1 CARTON (50580-317-06) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 10, 2020 | |
| 50580-317-12 | 5058003171250580031712 | 2 BLISTER PACK in 1 CARTON (50580-317-12) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 29, 2024 |
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)
- Imodium A-DSuffix: A-D
- Generic name (nonproprietary)
- loperamide hydrochloride
- Active ingredients
- Loperamide hydrochloride — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Kenvue Brands LLCNDC labeler code 50580
- 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 50580-317_3f75a619-8881-0bb3-e063-6394a90a1bccSPL ID 3f75a619-8881-0bb3-e063-6394a90a1bccSPL set ID 01da76d0-1979-4c45-9d39-c72ae4e4ffe2RxCUI 978010, 978013UNII 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
N450580031701followed by a unit qualifier and the quantityPackage 50580-0317-01. 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 50580-317
- What is NDC 50580-317?
- 50580-317 is the product NDC for Imodium A-D (loperamide hydrochloride), Loperamide hydrochloride 2 mg/1 tablet, film coated, listed with the FDA by Kenvue Brands LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imodium A-D (Loperamide hydrochloride).
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imodium A-D?
- 2 other product NDCs are listed under this name. See all Imodium A-D NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imodium A-D products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imodium A-Dloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | Kenvue Brands LLC | 50580-367 | 50580-0367-0150580-0367-02 |
| Imodium A-Dloperamide hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Kenvue Brands LLC | 50580-134 | 50580-0134-0450580-0134-0850580-0134-44 |
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 |
|---|---|---|---|---|
| Good Sense anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0224 |
| Leader Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0225 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-960 |
| basic care loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-224 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Redpharm Drug Inc | 67296-1472 |
| CareOne Diarrhea Controlloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-813 |
| dg health anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Dolgencorp, LLC | 55910-224 |
| Good Sense anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8750 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-224 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7725 |
| berkley and jensen anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | BJWC | 68391-224 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | H E B | 37808-552 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-2224 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1010 |
| Up and Up anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-224 |
| injoy diarrhea reliefloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-6004 |
| leader anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0589 |
| topcare anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-224 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-224 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-224 |
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