Over-the-counter drug · ANDA

Anti-Diarrheal (Loperamide hcl) NDC 63941-375

Loperamide hydrochloride 2 mg/1 · Tablet · Oral · Valu Merchandisers Company

NDC codes

FDA NDC Directory
Product NDC (as listed)63941-375Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63941-0375Add 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
63941-375-0263941037502639410375022 BLISTER PACK in 1 CARTON (63941-375-02) / 6 TABLET in 1 BLISTER PACKMarketed from May 5, 2020
63941-375-0863941037508639410375084 BLISTER PACK in 1 CARTON (63941-375-08) / 6 TABLET in 1 BLISTER PACKMarketed from May 5, 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)
Anti-Diarrheal
Generic name (nonproprietary)
loperamide hcl
Active ingredients
Loperamide hydrochloride — 2 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Valu Merchandisers CompanyNDC labeler code 63941
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076497
Marketing start
Marketing end
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 63941-375_c4f62471-381c-498b-984f-eb6e1de3a8d4SPL ID c4f62471-381c-498b-984f-eb6e1de3a8d4SPL set ID 70a7f827-f5be-454f-99bf-a7fd1037694eRxCUI 978010UNII 77TI35393CUPC 0070038615958
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

N463941037502 followed by a unit qualifier and the quantity

Package 63941-0375-02. 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)

About NDC 63941-375

What is NDC 63941-375?
63941-375 is the product NDC for Anti-Diarrheal (loperamide hcl), Loperamide hydrochloride 2 mg/1 tablet, listed with the FDA by Valu Merchandisers Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Anti-Diarrheal (Loperamide HCl).
What is the active ingredient?
Loperamide hydrochloride.
Who is the labeler?
Valu Merchandisers Company, NDC labeler code 63941. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Anti-Diarrheal?
73 other product NDCs are listed under this name. See all Anti-Diarrheal NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Anti-Diarrheal NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralKroger41226-79741226-0797-2241226-0797-24
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, CoatedOralGrocery Outlet85828-24885828-0248-93
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.83324-20883324-0208-12
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.83324-20983324-0209-24
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralAlbertsons Companies21130-83521130-0835-12
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralAdvanced Rx LLC80513-37580513-0375-08
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralSafeway21130-38121130-0381-34
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralPUBLIX SUPER MARKETS INC56062-68056062-0680-12
Anti Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralChain Drug Marketing Association, Inc.83324-06483324-0064-1283324-0064-24
Anti Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralYyba Corp73581-17173581-0171-24

All 74 Anti-Diarrheal NDCs

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/1CapsuleOralWinCo Foods67091-405
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralIMO-GEN LABS LLC84441-711
Anti Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralCHAIN DRUG MARKETING ASSOCIATION INC63868-559
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, CoatedOralFirst Aid Direct53117-248
Anti Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralWal-Mart Stores Inc49035-375
Anti-Diarrhealmarc glassmanLoperamide hydrochloride 2 mg/1CapsuleOralMarc Glassman, Inc.68998-248
First Aid Direct Anti-DiarrhealLoperamide hydrochloride 2 mg/1CapsuleOralCintas Corp42961-103
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralKroger Company30142-775
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralH E B37808-375
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralFamily Dollar Services Inc55319-375
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralRedpharm Drug67296-2314
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralDiscount Drug Mart53943-375
Anti-diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralBI-MART37835-131
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralGeri-Care Pharmaceutical Corp57896-381
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralWalgreen Company0363-0375
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/1TabletOralRite Aid Corporation11822-0375
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, CoatedOralGrocery Outlet85828-248
Anti-Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1TabletOralDOLGENCORP, LLC55910-375
WELMATE Anti Diarrheal Loperamide HClloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralYYBA CORP73581-101

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