Over-the-counter drug · ANDA

anti diarrheal (loperamide hydrochloride) NDC 0904-7725

Loperamide hydrochloride 2 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7725Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7725Add 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
0904-7725-120090477251212 BLISTER PACK in 1 CARTON (0904-7725-12) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 24, 2003
0904-7725-240090477252424 BLISTER PACK in 1 CARTON (0904-7725-24) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 24, 2003

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
anti diarrheal
Generic name (nonproprietary)
loperamide hydrochloride
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 0904-7725_6fd0ad94-87fe-4333-966b-ea405406344fSPL ID 6fd0ad94-87fe-4333-966b-ea405406344fSPL set ID be8f1c7d-fd4e-48d4-80b0-1d92a2ba6a70RxCUI 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

N400904772512 followed by a unit qualifier and the quantity

Package 00904-7725-12. 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 coatedOralCVS Pharmacy59779-700
topcare anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralTopco Associates LLC36800-224
Leader Anti Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. dba Leader70000-0225
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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