Over-the-counter drug · ANDA

loperamide hydrochloride (Loperamide hcl) NDC 68788-7842

Loperamide hydrochloride 1 mg/7.5mL · Solution · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7842Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7842Add 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
68788-7842-168788784201120 mL in 1 BOTTLE (68788-7842-1)Marketed from Jan 19, 2021

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)
loperamide hydrochloride
Generic name (nonproprietary)
loperamide hcl
Active ingredients
Loperamide hydrochloride — 1 mg/7.5mL
Dosage form
Solution
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091292
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 68788-7842_5e757cc6-98ac-427a-b594-47d815c4600fSPL ID 5e757cc6-98ac-427a-b594-47d815c4600fSPL set ID 0b1f8d41-51b3-4362-8de7-46bca5caff12RxCUI 1250685UNII 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

N468788784201 followed by a unit qualifier and the quantity

Package 68788-7842-01. 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 68788-7842

What is NDC 68788-7842?
68788-7842 is the product NDC for loperamide hydrochloride (loperamide hcl), Loperamide hydrochloride 1 mg/7.5mL solution, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
loperamide hydrochloride (Loperamide HCl).
What is the active ingredient?
Loperamide hydrochloride.
Who is the labeler?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for loperamide hydrochloride?
74 other product NDCs are listed under this name. See all loperamide hydrochloride 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 loperamide hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralYYBA CORP73581-17773581-0177-02
Loperamide Hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmazon.com Services LLC72288-04872288-0048-34
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralYYBA CORP73581-17573581-0175-24
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1CapsuleOralCardinal Health 107, LLC55154-027755154-0277-00
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralAurobindo Pharma Limited84386-11784386-0117-24
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1CapsuleOralCoupler LLC67046-167667046-1676-03
Loperamide HydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralDOLGENCORP INC55910-15555910-0155-55
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1CapsuleOralSafecor Health LLC48433-06348433-0063-20
Loperamide Hydrochlorideloperamide hydrochloride oralLoperamide hydrochloride 1 mg/7.5mLSolutionOralBionpharma Inc.69452-40569452-0405-5569452-0405-93
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralSportpharm LLC85766-15485766-0154-0685766-0154-12

All 75 loperamide hydrochloride NDCs

Other NDCs under ANDA 091292

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

FDA NDC Directory listings under ANDA 091292
ProductStrengthForm · routeLabelerProduct NDC
Loperamide HydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralPrecision Dose, Inc.68094-129
DG Health Anti Diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralDolgencorp Inc55910-867
Loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralCVS Pharmacy69842-191
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralMajor Pharmaceuticals0904-6836
anti-diarrhealloperamide hydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralSafeway21130-381
Equate Loperamide Hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSuspensionOralWal-Mart Stores Inc49035-451
leader anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralCardinal Health 110, LLC. dba Leader70000-0417
leader anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0418
Good Sense antidiarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralL. Perrigo Company0113-1645
basic care loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmazon.com Services LLC72288-645
Good Sense antidiarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralPreferred Pharmaceuticals Inc.68788-8796
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralATLANTIC BIOLOGICALS CORP.17856-6836
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralMeijer Distribution Inc41250-813
equate diarrhea controlloperamide hclLoperamide hydrochloride 1 mg/7.5mLSuspensionOralWal-Mart Stores Inc49035-695
Loperamide Hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmazon.com Services LLC72288-048
Anti Diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralWalgreen Company0363-2022
topcare loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralTopco Associates LLC36800-583
anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralH E B37808-449
equaline loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralUnited Natural Foods, Inc. dba UNFI41163-210
basic care loperamide hydrochlorideloperamide hydrochlorideLoperamide hydrochloride 1 mg/7.5mLSuspensionOralAmazon.com Services LLC72288-758

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