What is NDC 53041-263?

53041-263 is the product NDC for Loperamide Hydrochloride, Simethicone, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Loperamide hydrochloride, Dimethicone.

Guardian Drug Company, NDC labeler code 53041. 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, Simethicone?

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.

Loperamide Hydrochloride, Simethicone NDC 53041-263

NDC codes

FDA NDC Directory

Product NDC (as listed)53041-263Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53041-0263Add 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
53041-263-50	5304102635053041026350	1 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACKMarketed from Jun 1, 2021

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, Simethicone
Generic name (nonproprietary): loperamide hydrochloride, simethicone
Active ingredients: Loperamide hydrochloride — 2 mg/1Dimethicone — 125 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Guardian Drug CompanyNDC labeler code 53041
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214541
Marketing start: Jun 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Agonists (Mechanism)Skin Barrier Activity (Physiologic effect)
Identifiers: Product ID 53041-263_289e6064-8eb8-4b56-bc9e-ee82ad83674fSPL ID 289e6064-8eb8-4b56-bc9e-ee82ad83674fSPL set ID 1b79204e-8a99-455b-84d6-f381fd7d1135RxCUI 978001UNII 77TI35393C, 92RU3N3Y1O
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

N453041026350 followed by a unit qualifier and the quantity

Package 53041-0263-50. 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 Jun 1, 2021.

Indications (excerpt from the label)

USE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53041-263

What is NDC 53041-263?: 53041-263 is the product NDC for Loperamide Hydrochloride, Simethicone, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Loperamide Hydrochloride, Simethicone.
What is the active ingredient?: Loperamide hydrochloride, Dimethicone.
Who is the labeler?: Guardian Drug Company, NDC labeler code 53041. 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, Simethicone?: 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 214541

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

FDA NDC Directory listings under ANDA 214541
Product	Strength	Form · route	Labeler	Product NDC
Anti-Diarrheal/Anti-Gasloperamide hydrochloride, simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Discount Drug Mart, Inc	53943-263
Anti-Diarrheal/Anti-Gasloperamide hydrochloride, simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Harris Teeter, LLC	69256-265
Anti-Diarrheal/Anti-Gas Multi-Symptom Reliefloperamide hydrochloride 2mg, simethicone 125mg	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Wal-Mart Stores, Inc.	79903-116
Equate Anti Diarrheal Anti Gas Multi-Symptom Reliefloperamide hydrochloride, simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	WALMART INC.	79903-302