Over-the-counter drug · ANDA

Good Sense anti diarrheal (Loperamide hydrochloride) NDC 0113-0224

Loperamide hydrochloride 2 mg/1 · Tablet, Film coated · Oral · L. Perrigo Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0113-0224Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00113-0224Add 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
0113-0224-53001130224530011302245312 BLISTER PACK in 1 CARTON (0113-0224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 8, 2003
0113-0224-62001130224620011302246224 BLISTER PACK in 1 CARTON (0113-0224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 25, 2010
0113-0224-9100113022491001130224916 BLISTER PACK in 1 CARTON (0113-0224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 25, 2003

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)
Good Sense anti diarrheal
Generic name (nonproprietary)
loperamide hydrochloride
Active ingredients
Loperamide hydrochloride — 2 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
L. Perrigo CompanyNDC labeler code 0113
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 0113-0224_d79c9122-ab64-4596-8496-cef5ada33d66SPL ID d79c9122-ab64-4596-8496-cef5ada33d66SPL set ID 9c1d811d-f8d0-418c-aaf7-7b6477deea20RxCUI 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

N400113022453 followed by a unit qualifier and the quantity

Package 00113-0224-53. 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 0113-0224

What is NDC 0113-0224?
0113-0224 is the product NDC for Good Sense anti diarrheal (loperamide hydrochloride), Loperamide hydrochloride 2 mg/1 tablet, film coated, listed with the FDA by L. Perrigo Company. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Good Sense anti diarrheal (Loperamide Hydrochloride).
What is the active ingredient?
Loperamide hydrochloride.
Who is the labeler?
L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Good Sense anti diarrheal?
3 other product NDCs are listed under this name. See all Good Sense 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 Good Sense anti diarrheal NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Good Sense anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-875068788-8750-02
Good Sense anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-66351655-0663-54
Good Sense anti diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralProficient Rx LP71205-07971205-0079-12

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
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
anti diarrhealloperamide hclLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralWalgreen Company0363-1010
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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