Over-the-counter drug · NDA

WELMATE Anti Diarrheal Loperamide HCl Softgels NDC 73581-102

loperamide hydrochloride · Loperamide hydrochloride 2 mg/1 · Capsule · Oral · YYBA CORP

NDC codes

FDA NDC Directory
Product NDC (as listed)73581-102Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73581-0102Add 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
73581-102-24735810102242 BLISTER PACK in 1 CARTON (73581-102-24) / 12 CAPSULE in 1 BLISTER PACKMarketed from Aug 22, 2020

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)
WELMATE Anti Diarrheal Loperamide HCl Softgels
Generic name (nonproprietary)
loperamide hydrochloride
Active ingredients
Loperamide hydrochloride — 2 mg/1
Dosage form
Capsule
Route
Oral
Labeler
YYBA CORP
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 73581-102_ec6b87f1-e600-21c2-e053-2a95a90ab76dSPL ID ec6b87f1-e600-21c2-e053-2a95a90ab76dSPL set ID ae2e15e9-1707-296d-e053-2995a90a1b95RxCUI 978006UNII 77TI35393CUPC 0373581102242
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

N473581010224 followed by a unit qualifier and the quantity

Package 73581-0102-24. 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)

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 filledOralNortheast Pharma80136-851
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralSTRATEGIC SOURCING SERVICES70677-1062
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.83324-208
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.83324-209
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralHEB37808-988
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralMEIJER DISTRIBUTION INC41250-210
Imodium A-Dloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralKenvue Brands LLC50580-367
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralTARGET Corporation11673-177
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralStrategic Sourcing Services LLC62011-0390
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralKROGER COMPANY30142-159
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralWALGREENS0363-1176
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralDISCOUNT DRUG MART, INC.53943-176
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralAmazon.com Services LLC72288-313
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralTOP CARE (Topco Associates LLC)36800-208
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralRite Aid Corporation11822-7834
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralCVS Pharmacy, Inc.69842-061
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-176
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralAlbertsons Companies21130-835
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralAMERISOURCE BERGEN46122-581
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralDOLGENCORP, LLC55910-176

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