Loperamide Hydrochloride NDC 58602-701

NDC codes

FDA NDC Directory

Product NDC (as listed)58602-701Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58602-0701Add 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
58602-701-01	58602070101	1 BLISTER PACK in 1 CARTON (58602-701-01) / 6 TABLET in 1 BLISTER PACKMarketed from Dec 15, 2015
58602-701-02	58602070102	2 BLISTER PACK in 1 CARTON (58602-701-02) / 6 TABLET in 1 BLISTER PACKMarketed from Dec 15, 2015
58602-701-76	58602070176	4 BLISTER PACK in 1 CARTON (58602-701-76) / 6 TABLET in 1 BLISTER PACKMarketed from Dec 15, 2015

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): Loperamide Hydrochloride
Generic name (nonproprietary): loperamide hydrochloride
Active ingredients: Loperamide hydrochloride — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurohealth LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206548
Marketing start: Dec 15, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 58602-701_1645400c-43fb-4b64-98bc-33f85ce827f7SPL ID 1645400c-43fb-4b64-98bc-33f85ce827f7SPL set ID f3ea8779-252e-4038-ae41-500e15c54825RxCUI 978010UNII 77TI35393CUPC 0358602701765
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

N458602070101 followed by a unit qualifier and the quantity

Package 58602-0701-01. 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 Jan 22, 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)

Other NDCs under ANDA 206548

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

FDA NDC Directory listings under ANDA 206548
Product	Strength	Form · route	Labeler	Product NDC
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Amerisource Bergen	46122-738
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Aurobindo Pharma Limited	84386-117
Amazon Basic Care Loperamide Hydrochlorideloperamide hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Amazon.com Services LLC	72288-225
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	YYBA CORP	73581-175
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8393
Amazon Basic Care Loperamide Hydrochlorideloperamide hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Proficient Rx LP	82804-295
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Aurohealth LLC	58602-870