Over-the-counter drug · NDA

Anti-Diarrheal (Loperamide hydrochloride) NDC 70000-0461

Loperamide hydrochloride 2 mg/1 · Capsule, Liquid filled · Oral · CARDINAL HEALTH

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0461Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0461Add 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
70000-0461-170000046101700000461012 BLISTER PACK in 1 CARTON (70000-0461-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jan 21, 2019

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)
Anti-Diarrheal
Generic name (nonproprietary)
loperamide hydrochloride
Active ingredients
Loperamide hydrochloride — 2 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
CARDINAL HEALTHNDC labeler code 70000
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021855
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 70000-0461_19c647b6-61c7-68ed-e063-6294a90a02ffSPL ID 19c647b6-61c7-68ed-e063-6294a90a02ffSPL set ID bd58d6e9-628c-4c6b-b44c-da95e0417ba7RxCUI 978006UNII 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

N470000046101 followed by a unit qualifier and the quantity

Package 70000-0461-01. 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 70000-0461

What is NDC 70000-0461?
70000-0461 is the product NDC for Anti-Diarrheal (loperamide hydrochloride), Loperamide hydrochloride 2 mg/1 capsule, liquid filled, listed with the FDA by CARDINAL HEALTH. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Anti-Diarrheal (Loperamide hydrochloride).
What is the active ingredient?
Loperamide hydrochloride.
Who is the labeler?
CARDINAL HEALTH, NDC labeler code 70000. 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 NDA 021855

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

FDA NDC Directory listings under NDA 021855
ProductStrengthForm · routeLabelerProduct NDC
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralWALGREENS0363-1176
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralTARGET Corporation11673-177
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralRite Aid Corporation11822-7834
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralAlbertsons Companies21130-835
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralKROGER COMPANY30142-159
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralTOP CARE (Topco Associates LLC)36800-208
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralHEB37808-988
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralMEIJER DISTRIBUTION INC41250-210
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralAMERISOURCE BERGEN46122-581
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralWal-Mart Stores, Inc.49035-483
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralDISCOUNT DRUG MART, INC.53943-176
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralDOLGENCORP, LLC55910-176
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralPUBLIX SUPER MARKETS INC56062-680
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralStrategic Sourcing Services LLC62011-0390
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.63868-876
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralVALU MERCHANDISERS COMPANY63941-684
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralPremier Value Alliance LLC68016-058
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-176
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-266
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralCVS Pharmacy, Inc.69842-061

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