Over-the-counter drug · ANDA

Leader Anti Diarrheal (loperamide hcl) NDC 70000-0225

Loperamide hydrochloride 2 mg/1 · Tablet, Film coated · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0225Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0225Add 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
70000-0225-27000002250212 BLISTER PACK in 1 CARTON (70000-0225-2) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 2, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Leader Anti Diarrheal
Generic name (nonproprietary)
loperamide hcl
Active ingredients
Loperamide hydrochloride — 2 mg/1
Dosage form
Tablet, Film coated
Route
Oral
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 70000-0225_dd0ee798-d323-4d39-a04c-d2e10df1cd2fSPL ID dd0ee798-d323-4d39-a04c-d2e10df1cd2fSPL set ID 9079a59b-a158-4e77-a104-547959f7ba78RxCUI 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

N470000022502 followed by a unit qualifier and the quantity

Package 70000-0225-02. 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 ANDA 075232

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

FDA NDC Directory listings under ANDA 075232
ProductStrengthForm · routeLabelerProduct NDC
Up and Up anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralTarget Corporation11673-224
Imodium A-Dloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-317
Good Sense anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralProficient Rx LP71205-079
anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-224
leader anti diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. dba Leader70000-0589
CareOne Diarrhea Controlloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralAmerican Sales Company41520-813
foster and thrive anti diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1106
Good Sense anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralL. Perrigo Company0113-0224
Good Sense anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-663
anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-224
basic care loperamide hydrochlorideloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-224
Anti Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralH E B37808-552
anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7725
anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralCVS Pharmacy59779-700
topcare anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralTopco Associates LLC36800-224
anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralRedpharm Drug Inc67296-1472
anti diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralWalgreen Company0363-1010
dg health anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralDolgencorp, LLC55910-224
anti diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralCVS Pharmacy59779-960
berkley and jensen anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralBJWC68391-224

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