What is NDC 36800-583?

36800-583 is the product NDC for topcare loperamide hydrochloride (loperamide hcl), Loperamide hydrochloride 1 mg/7.5mL solution, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

topcare loperamide hydrochloride (Loperamide HCl).

Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for topcare loperamide hydrochloride?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

topcare loperamide hydrochloride NDC 36800-583

NDC codes

FDA NDC Directory

Product NDC (as listed)36800-583Labeler and product segments. Claims need a package NDC.

Product NDC at billing width36800-0583Add 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 NDC	11-digit (billing)	Package	Copy
36800-583-26	3680005832636800058326	120 mL in 1 BOTTLE (36800-583-26)Marketed from Sep 12, 2018
36800-583-34	3680005833436800058334	240 mL in 1 BOTTLE (36800-583-34)Marketed from Sep 16, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): topcare loperamide hydrochloride
Generic name (nonproprietary): loperamide hcl
Active ingredients: Loperamide hydrochloride — 1 mg/7.5mL
Dosage form: Solution
Route: Oral
Labeler: Topco Associates LLCNDC labeler code 36800
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091292
Marketing start: Sep 12, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 36800-583_dc29e904-1358-4d41-8eed-d83136200862SPL ID dc29e904-1358-4d41-8eed-d83136200862SPL set ID 1cd497b4-d97e-447a-9251-710d2fddbf23RxCUI 1250685UNII 77TI35393CUPC 0036800367531
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

N436800058326 followed by a unit qualifier and the quantity

Package 36800-0583-26. 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 Apr 1, 2025.

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 36800-583

What is NDC 36800-583?: 36800-583 is the product NDC for topcare loperamide hydrochloride (loperamide hcl), Loperamide hydrochloride 1 mg/7.5mL solution, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: topcare loperamide hydrochloride (Loperamide HCl).
What is the active ingredient?: Loperamide hydrochloride.
Who is the labeler?: Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for topcare loperamide hydrochloride?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Product	Strength	Form · route	Labeler	Product NDC
basic care loperamide hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Amazon.com Services LLC	72288-645
Loperamide Hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Amazon.com Services LLC	72288-048
loperamide hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Major Pharmaceuticals	0904-6836
Equate Loperamide Hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SuspensionOral	Wal-Mart Stores Inc	49035-451
basic care loperamide hydrochlorideloperamide hydrochloride	Loperamide hydrochloride 1 mg/7.5mL	SuspensionOral	Amazon.com Services LLC	72288-758
loperamide hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	ATLANTIC BIOLOGICALS CORP.	17856-6836
loperamide hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Meijer Distribution Inc	41250-813
Loperamide hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	CVS Pharmacy	69842-191
loperamide hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Preferred Pharmaceuticals Inc.	68788-7842
leader anti diarrhealloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Cardinal Health 110, LLC. dba Leader	70000-0417
Loperamide Hydrochloride	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Precision Dose, Inc.	68094-029
leader anti diarrhealloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SuspensionOral	Cardinal Health 110, LLC. dba Leader	70000-0418
CareOne Diarrhea Controlloperamide hydrochloride	Loperamide hydrochloride 1 mg/7.5mL	SuspensionOral	American Sales Company	41520-841
anti diarrhealloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	H E B	37808-449
DG Health Anti Diarrhealloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Dolgencorp Inc	55910-867
Loperamide Hydrochloride	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Precision Dose, Inc.	68094-129
equaline loperamide hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	United Natural Foods, Inc. dba UNFI	41163-210
loperamide hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Rite Aid Corporation	11822-5519
equate diarrhea controlloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SuspensionOral	Wal-Mart Stores Inc	49035-695
Good Sense antidiarrhealloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Preferred Pharmaceuticals Inc.	68788-8796

Showing 20 of 28.

topcare loperamide hydrochloride (Loperamide hcl) NDC 36800-583