Over-the-counter drug · NDA
Imodium A-D (Loperamide hydrochloride) NDC 50580-134
Loperamide hydrochloride 1 mg/7.5mL · Solution · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-134-04 | 5058001340450580013404 | 120 mL in 1 BOTTLE (50580-134-04)Marketed from Jul 1, 2004 | |
| 50580-134-08 | 5058001340850580013408 | 240 mL in 1 BOTTLE (50580-134-08)Marketed from Jul 1, 2004 | |
| 50580-134-44 | 5058001344450580013444 | 120 mL in 1 BOTTLE (50580-134-44)Marketed from Jul 1, 2004 |
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 — 1 mg/7.5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Kenvue Brands LLCNDC labeler code 50580
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019487
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 50580-134_3f73b325-ad6b-8e65-e063-6394a90a361eSPL ID 3f73b325-ad6b-8e65-e063-6394a90a361eSPL set ID 76a976d5-8bee-4158-a94d-7fbfc5544fd4RxCUI 1250685, 1250693UNII 77TI35393CUPC 0300450134080
- 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
N450580013404followed by a unit qualifier and the quantityPackage 50580-0134-04. 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 50580-134
- What is NDC 50580-134?
- 50580-134 is the product NDC for Imodium A-D (loperamide hydrochloride), Loperamide hydrochloride 1 mg/7.5mL solution, listed with the FDA by Kenvue Brands LLC. It has 3 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 2 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-317 | 50580-0317-0150580-0317-0350580-0317-06+1 more |