Over-the-counter drug · NDA

Imodium A-D (Loperamide hydrochloride) NDC 50580-367

Loperamide hydrochloride 2 mg/1 · Capsule, Liquid filled · Oral · Kenvue Brands LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)50580-367Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0367Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50580-367-0150580036701505800367011 BLISTER PACK in 1 CARTON (50580-367-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jul 11, 2016
50580-367-0250580036702505800367022 BLISTER PACK in 1 CARTON (50580-367-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jul 11, 2016

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-D
Generic name (nonproprietary)
loperamide hydrochloride
Active ingredients
Loperamide hydrochloride — 2 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Kenvue Brands LLCNDC labeler code 50580
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021855
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 50580-367_460d0a84-5c0c-b974-e063-6294a90ab761SPL ID 460d0a84-5c0c-b974-e063-6294a90ab761SPL set ID 31bfcbb4-c58c-4edc-ac68-356a448b7507RxCUI 978006, 978009UNII 77TI35393CUPC 0300450137241
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

N450580036701 followed by a unit qualifier and the quantity

Package 50580-0367-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 50580-367

What is NDC 50580-367?
50580-367 is the product NDC for Imodium A-D (loperamide hydrochloride), Loperamide hydrochloride 2 mg/1 capsule, liquid filled, listed with the FDA by Kenvue Brands LLC. It has 2 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Imodium A-D NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Imodium A-Dloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-31750580-0317-0150580-0317-0350580-0317-06+1 more
Imodium A-Dloperamide hydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralKenvue Brands LLC50580-13450580-0134-0450580-0134-0850580-0134-44

Other NDCs under NDA 021855

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021855
ProductStrengthForm · routeLabelerProduct NDC
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralWALGREENS0363-1176
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralTARGET Corporation11673-177
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralRite Aid Corporation11822-7834
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralAlbertsons Companies21130-835
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralKROGER COMPANY30142-159
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralTOP CARE (Topco Associates LLC)36800-208
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralHEB37808-988
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralMEIJER DISTRIBUTION INC41250-210
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralAMERISOURCE BERGEN46122-581
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralWal-Mart Stores, Inc.49035-483
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralDISCOUNT DRUG MART, INC.53943-176
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralDOLGENCORP, LLC55910-176
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralPUBLIX SUPER MARKETS INC56062-680
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralStrategic Sourcing Services LLC62011-0390
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.63868-876
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralVALU MERCHANDISERS COMPANY63941-684
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralPremier Value Alliance LLC68016-058
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-176
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-266
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralCVS Pharmacy, Inc.69842-061

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