Over-the-counter drug · ANDA

anti diarrheal (Loperamide hcl) NDC 0363-1010

Loperamide hydrochloride 2 mg/1 · Tablet, Film coated · Oral · Walgreen Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-1010Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-1010Add 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
0363-1010-53003631010530036310105312 BLISTER PACK in 1 CARTON (0363-1010-53) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 11, 2021
0363-1010-62003631010620036310106224 BLISTER PACK in 1 CARTON (0363-1010-62) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 14, 2021
0363-1010-9100363101091003631010916 BLISTER PACK in 1 CARTON (0363-1010-91) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 14, 2021

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 — 2 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Walgreen CompanyNDC labeler code 0363
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 0363-1010_8b29d4fe-54cf-45df-8849-9b57026ba151SPL ID 8b29d4fe-54cf-45df-8849-9b57026ba151SPL set ID 6e0dfbb3-6c58-40fc-83b4-09ee10576ae5RxCUI 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

N400363101053 followed by a unit qualifier and the quantity

Package 00363-1010-53. 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 0363-1010

What is NDC 0363-1010?
0363-1010 is the product NDC for anti diarrheal (loperamide hcl), Loperamide hydrochloride 2 mg/1 tablet, film coated, listed with the FDA by Walgreen Company. It has 3 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?
Walgreen Company, NDC labeler code 0363. 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 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
Good Sense anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralL. Perrigo Company0113-0224
Leader Anti Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. dba Leader70000-0225
anti diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralCVS Pharmacy59779-960
basic care loperamide hydrochlorideloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-224
anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralRedpharm Drug Inc67296-1472
CareOne Diarrhea Controlloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralAmerican Sales Company41520-813
dg health anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralDolgencorp, LLC55910-224
Good Sense anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8750
anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-224
anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7725
berkley and jensen anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralBJWC68391-224
Anti Diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralH E B37808-552
anti diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralL. Perrigo Company0113-2224
Up and Up anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralTarget Corporation11673-224
injoy diarrhea reliefloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralL. Perrigo Company0113-6004
leader anti diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. dba Leader70000-0589
topcare anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralTopco Associates LLC36800-224
Imodium A-Dloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-317
anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-224
anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralHyVee Inc42507-224

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