Over-the-counter drug · ANDA

loperamide hydrochloride (Loperamide hcl) NDC 0904-6836

Loperamide hydrochloride 1 mg/7.5mL · Solution · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6836Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6836Add 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
0904-6836-200090468362000904683620120 mL in 1 BOTTLE (0904-6836-20)Marketed from Nov 29, 2018

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)
loperamide hydrochloride
Generic name (nonproprietary)
loperamide hcl
Active ingredients
Loperamide hydrochloride — 1 mg/7.5mL
Dosage form
Solution
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
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 0904-6836_82067b3e-6f6d-4cd0-9bf7-bfbe3eab10e6SPL ID 82067b3e-6f6d-4cd0-9bf7-bfbe3eab10e6SPL set ID cf5dc855-f0cc-4d7e-8d15-472f7e654409RxCUI 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

N400904683620 followed by a unit qualifier and the quantity

Package 00904-6836-20. 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 0904-6836

What is NDC 0904-6836?
0904-6836 is the product NDC for loperamide hydrochloride (loperamide hcl), Loperamide hydrochloride 1 mg/7.5mL solution, listed with the FDA by Major Pharmaceuticals. 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?
Major Pharmaceuticals, NDC labeler code 0904. 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
basic care loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmazon.com Services LLC72288-645
Loperamide Hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmazon.com Services LLC72288-048
Equate Loperamide Hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSuspensionOralWal-Mart Stores Inc49035-451
basic care loperamide hydrochlorideloperamide hydrochlorideLoperamide hydrochloride 1 mg/7.5mLSuspensionOralAmazon.com Services LLC72288-758
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralATLANTIC BIOLOGICALS CORP.17856-6836
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralMeijer Distribution Inc41250-813
Loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralCVS Pharmacy69842-191
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralPreferred Pharmaceuticals Inc.68788-7842
leader anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralCardinal Health 110, LLC. dba Leader70000-0417
Loperamide HydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralPrecision Dose, Inc.68094-029
leader anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0418
CareOne Diarrhea Controlloperamide hydrochlorideLoperamide hydrochloride 1 mg/7.5mLSuspensionOralAmerican Sales Company41520-841
topcare loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralTopco Associates LLC36800-583
anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralH E B37808-449
DG Health Anti Diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralDolgencorp Inc55910-867
Loperamide HydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralPrecision Dose, Inc.68094-129
equaline loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralUnited Natural Foods, Inc. dba UNFI41163-210
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralRite Aid Corporation11822-5519
equate diarrhea controlloperamide hclLoperamide hydrochloride 1 mg/7.5mLSuspensionOralWal-Mart Stores Inc49035-695
Good Sense antidiarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralPreferred Pharmaceuticals Inc.68788-8796

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