Over-the-counter drug · ANDA

Anti Diarrheal (loperamide hcl) NDC 0363-2022

Loperamide hydrochloride 1 mg/7.5mL · Solution · Oral · Walgreen Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-2022Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-2022Add 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
0363-2022-2600363202226120 mL in 1 BOTTLE (0363-2022-26)Marketed from Mar 21, 2022
0363-2022-3400363202234240 mL in 1 BOTTLE (0363-2022-34)Marketed from Mar 21, 2022

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 hcl
Active ingredients
Loperamide hydrochloride — 1 mg/7.5mL
Dosage form
Solution
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091292
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 0363-2022_c728470a-d949-43c1-9f56-9cf6706fd4c8SPL ID c728470a-d949-43c1-9f56-9cf6706fd4c8SPL set ID f70d0568-27c0-4c63-8d68-82e31b87174fRxCUI 1250685UNII 77TI35393CUPC 0311917037592
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

N400363202226 followed by a unit qualifier and the quantity

Package 00363-2022-26. 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 091292

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

FDA NDC Directory listings under ANDA 091292
ProductStrengthForm · routeLabelerProduct NDC
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralMajor Pharmaceuticals0904-6836
basic care loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmazon.com Services LLC72288-645
Good Sense antidiarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralL. Perrigo Company0113-1645
Good Sense antidiarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralPreferred Pharmaceuticals Inc.68788-8796
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralATLANTIC BIOLOGICALS CORP.17856-6836
Loperamide Hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmazon.com Services LLC72288-048
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralMeijer Distribution Inc41250-813
equate diarrhea controlloperamide hclLoperamide hydrochloride 1 mg/7.5mLSuspensionOralWal-Mart Stores Inc49035-695
topcare loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralTopco Associates LLC36800-583
anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralH E B37808-449
basic care loperamide hydrochlorideloperamide hydrochlorideLoperamide hydrochloride 1 mg/7.5mLSuspensionOralAmazon.com Services LLC72288-758
equaline loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralUnited Natural Foods, Inc. dba UNFI41163-210
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralRite Aid Corporation11822-5519
CareOne Diarrhea Controlloperamide hydrochlorideLoperamide hydrochloride 1 mg/7.5mLSuspensionOralAmerican Sales Company41520-841
foster and thrive anti-diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralStrategic Sourcing Services LLC70677-1107
Up and Up anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSuspensionOralTarget Corporation11673-900
good neighbor pharmacy loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmerisource Bergen46122-544
Loperamide HydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralPrecision Dose, Inc.68094-029
anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralKroger Company30142-514
Loperamide HydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralPrecision Dose, Inc.68094-129

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