NDC codes

FDA NDC Directory
Product NDC (as listed)53943-375Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0375Add 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
53943-375-02539430375022 BLISTER PACK in 1 CARTON (53943-375-02) / 6 TABLET in 1 BLISTER PACKMarketed from Dec 13, 2019
53943-375-08539430375084 BLISTER PACK in 1 CARTON (53943-375-08) / 6 TABLET in 1 BLISTER PACKMarketed from Dec 13, 2019

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)
Anti-Diarrheal
Generic name (nonproprietary)
loperamide hcl
Active ingredients
Loperamide hydrochloride — 2 mg/1
Dosage form
Tablet
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076497
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 53943-375_9714b33f-b318-4260-8093-8017ffbea6fbSPL ID 9714b33f-b318-4260-8093-8017ffbea6fbSPL set ID 91843b17-3c04-482c-a2ba-143193be1595RxCUI 978010UNII 77TI35393CUPC 0093351030659
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

N453943037502 followed by a unit qualifier and the quantity

Package 53943-0375-02. 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 076497

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

FDA NDC Directory listings under ANDA 076497
ProductStrengthForm · routeLabelerProduct NDC
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralH E B37808-375
Anti-Diarrheal, 24/7 Life by 7-Elevenloperamide hcl tabletLoperamide hydrochloride 2 mg/1TabletOralLil' Drug Store Products, Inc.66715-4644
Anti Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralARMY AND AIR FORCE EXCHANGE SERVICE55301-375
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralDOLGENCORP, LLC55910-375
First Aid Direct Anti-DiarrhealLoperamide hydrochloride 2 mg/1CapsuleOralCintas Corp42961-103
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralAdvanced Rx LLC80513-375
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralAdvanced Rx LLC80513-401
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralKroger Company30142-775
Anti-diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralChain Drug Consortium68016-301
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralHeartland Pharma Co.80136-063
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, CoatedOralAllegiant Health69168-248
Anti-diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralBI-MART37835-131
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralL.N.K. International, Inc.50844-259
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralRite Aid Corporation11822-0375
Anti-diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralL.N.K. International, Inc.50844-375
Loperamide HClLoperamide hydrochloride 2 mg/1TabletOralL.N.K. International, Inc.50844-735
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralWinCo Foods, LLC67091-335
Anti Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralChain Drug Marketing Association, Inc.83324-064
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralUnited Natural Foods, Inc. dba UNFI41163-375
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, CoatedOralFirst Aid Direct53117-248

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