What is NDC 55289-315?

55289-315 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 capsule, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.

PD-Rx Pharmaceuticals, Inc., NDC labeler code 55289. 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 55289-315

NDC codes

FDA NDC Directory

Product NDC (as listed)55289-315Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55289-0315Add 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
55289-315-06	5528903150655289031506	6 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-06)Marketed from Sep 23, 2011
55289-315-08	5528903150855289031508	8 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-08)Marketed from Sep 23, 2011
55289-315-10	5528903151055289031510	10 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-10)Marketed from Sep 23, 2011
55289-315-12	5528903151255289031512	12 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-12)Marketed from Sep 23, 2011
55289-315-15	5528903151555289031515	15 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-15)Marketed from Sep 23, 2011
55289-315-20	5528903152055289031520	20 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-20)Marketed from Sep 23, 2011
55289-315-30	5528903153055289031530	30 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-30)Marketed from Sep 23, 2011

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: Capsule
Route: Oral
Labeler: PD-Rx Pharmaceuticals, Inc.NDC labeler code 55289
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 073192
Marketing start: May 1, 1993
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 55289-315_4199e187-f646-693a-e063-6294a90ae583SPL ID 4199e187-f646-693a-e063-6294a90ae583SPL set ID 3310a3c2-389a-4b27-a478-67c905789854RxCUI 978006UNII 77TI35393CUPC 0355289315155
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

N455289031506 followed by a unit qualifier and the quantity

Package 55289-0315-06. 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 Oct 20, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Loperamide hydrochloride is 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 55289-315

What is NDC 55289-315?: 55289-315 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 capsule, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 7 package NDCs, 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?: PD-Rx Pharmaceuticals, Inc., NDC labeler code 55289. 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 073192

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

FDA NDC Directory listings under ANDA 073192
Product	Strength	Form · route	Labeler	Product NDC
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-0311
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	43063-020
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	A-S Medication Solutions	50090-0460
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-4699
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	American Health Packaging	60687-229
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8747
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	NuCare Pharmaceuticals, Inc.	66267-132
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-2257
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-973