What is NDC 35418-123?

35418-123 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 tablet, listed with the FDA by Zee Medical Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Zee Medical Inc, NDC labeler code 35418. 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 35418-123

NDC codes

FDA NDC Directory

Product NDC (as listed)35418-123Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35418-0123Add 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
35418-123-12	3541801231235418012312	2 BLISTER PACK in 1 CARTON (35418-123-12) / 6 TABLET in 1 BLISTER PACKMarketed from Jan 16, 2014

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: Zee Medical IncNDC labeler code 35418
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074091
Marketing start: Jan 16, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 35418-123_0ea718d4-6b2b-b9ee-e063-6294a90a8111SPL ID 0ea718d4-6b2b-b9ee-e063-6294a90a8111SPL set ID 07e1f89c-5bf6-4539-848a-4435e7deb0d2RxCUI 978010UNII 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

N435418012312 followed by a unit qualifier and the quantity

Package 35418-0123-12. 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 11, 2024.

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 35418-123

What is NDC 35418-123?: 35418-123 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 tablet, listed with the FDA by Zee Medical Inc. 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?: Zee Medical Inc, NDC labeler code 35418. 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 074091

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

FDA NDC Directory listings under ANDA 074091
Product	Strength	Form · route	Labeler	Product NDC
Anti-Diarrhealloperamide hci	Loperamide hydrochloride 2 mg/1	TabletOral	Lil' Drug Store Products, Inc.	29485-9286
Anti-Diarrheal, Caseys 4goodloperamide hcl	Loperamide hydrochloride 2 mg/1	TabletOral	Lil' Drug Store Products, Inc.	66715-6359
Anti-Diarrheal, Circle Kloperamide hcl tablet	Loperamide hydrochloride 2 mg/1	TabletOral	Lil' Drug Store Products, Inc.	66715-5529
Anti-Diarrheal, CVP HEALTHloperamide hcl	Loperamide hydrochloride 2 mg/1	TabletOral	Lil' Drug Store Products, Inc.	66715-6559
Handy Solutions Anti-Diarrhealloperamide hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Navajo Manufacturing Company Inc.	67751-162
Lil Drug Store Anti-Diarrhealloperamide hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Lil' Drug Store Products, Inc.	66715-9859
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Ohm Laboratories Inc.	51660-123
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Discount Drug Mart	53943-123
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Fred's Inc.	55315-123
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Proficient Rx LP	63187-462
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Chain Drug Marketing Association Inc.	63868-338
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Valu Merchandisers Company	63941-123
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Chain Drug Consortium, LLC	68016-123
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Marc Glassman, Inc.	68998-123
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Sportpharm LLC	85766-154
MEDIQUE Diamodeloperamide hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Unifirst First Aid Corporation	47682-200
MEDIQUE Diamodeloperamide hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Unifirst First Aid Corporation	47682-400
MEDIQUE Diamodeloperamide hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Proficient Rx LP	71205-316
MEDIQUE Diamodeloperamide hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Sportpharm LLC	85766-120
Private Label Distributorloperamide hcl 2 mg	Loperamide hydrochloride 2 mg/1	TabletOral	Unifirst First Aid Corporation	47682-021