What is NDC 0615-8497?

0615-8497 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 capsule, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Loperamide Hydrochloride NDC 0615-8497

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8497Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8497Add 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
0615-8497-39	0061584973900615849739	30 CAPSULE in 1 BLISTER PACK (0615-8497-39)Marketed from Jan 12, 2024

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 hydrochloride
Active ingredients: Loperamide hydrochloride — 2 mg/1
Dosage form: Capsule
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216876
Marketing start: Jan 26, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 0615-8497_96819325-1225-4982-8e6a-85b217a6b6d8SPL ID 96819325-1225-4982-8e6a-85b217a6b6d8SPL set ID f245e8f4-e06e-492e-8c46-af1fce1633fcRxCUI 978006UNII 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

N400615849739 followed by a unit qualifier and the quantity

Package 00615-8497-39. 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 Aug 9, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8497

What is NDC 0615-8497?: 0615-8497 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 capsule, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Loperamide Hydrochloride.
What is the active ingredient?: Loperamide hydrochloride.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	Capsule, Liquid filledOral	YYBA CORP	73581-177	73581-0177-02
Loperamide Hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Amazon.com Services LLC	72288-048	72288-0048-34
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	YYBA CORP	73581-175	73581-0175-24
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0277	55154-0277-00
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Aurobindo Pharma Limited	84386-117	84386-0117-24
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Coupler LLC	67046-1676	67046-1676-03
Loperamide Hydrochloride	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	DOLGENCORP INC	55910-155	55910-0155-55
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Safecor Health LLC	48433-063	48433-0063-20
Loperamide Hydrochlorideloperamide hydrochloride oral	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Bionpharma Inc.	69452-405	69452-0405-5569452-0405-93
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Sportpharm LLC	85766-154	85766-0154-0685766-0154-12

All 75 Loperamide Hydrochloride NDCs

Other NDCs under ANDA 216876

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

FDA NDC Directory listings under ANDA 216876
Product	Strength	Form · route	Labeler	Product NDC
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2487
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Advagen Pharma Ltd.,	72888-130