What is NDC 55319-052?

55319-052 is the product NDC for Loperamide Hydrochloride and Simethicone, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by Family Dollar Stores, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Loperamide hydrochloride, Dimethicone.

Family Dollar Stores, LLC, NDC labeler code 55319. 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 and Simethicone?

13 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 and Simethicone NDC 55319-052

NDC codes

FDA NDC Directory

Product NDC (as listed)55319-052Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55319-0052Add 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
55319-052-75	5531900527555319005275	2 BLISTER PACK in 1 CARTON (55319-052-75) / 6 TABLET in 1 BLISTER PACKMarketed from Aug 11, 2023

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 and Simethicone
Generic name (nonproprietary): loperamide hydrochloride and simethicone
Active ingredients: Loperamide hydrochloride — 2 mg/1Dimethicone — 125 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Family Dollar Stores, LLCNDC labeler code 55319
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211059
Marketing start: Aug 11, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Opioid Agonists (Mechanism)Skin Barrier Activity (Physiologic effect)
Identifiers: Product ID 55319-052_dfa3e363-cb7c-4f7a-9404-04f70312ab53SPL ID dfa3e363-cb7c-4f7a-9404-04f70312ab53SPL set ID f86d2c23-c43a-4190-e053-6394a90a95ccRxCUI 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

N455319005275 followed by a unit qualifier and the quantity

Package 55319-0052-75. 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 7, 2025.

Indications (excerpt from the label)

Uses 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 55319-052

What is NDC 55319-052?: 55319-052 is the product NDC for Loperamide Hydrochloride and Simethicone, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by Family Dollar Stores, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Loperamide Hydrochloride and Simethicone.
What is the active ingredient?: Loperamide hydrochloride, Dimethicone.
Who is the labeler?: Family Dollar Stores, LLC, NDC labeler code 55319. 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 and Simethicone?: 13 other product NDCs are listed under this name. See all Loperamide Hydrochloride and Simethicone 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 and Simethicone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
loperamide hydrochloride and simethiconeloperamide hydrochloride, simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Amazon.com Services LLC	72288-728	72288-0728-62
Loperamide hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Bionpharma Inc.	69452-531	69452-0531-12
Loperamide Hydrochloride and Simethicone	Dimethicone 125 mg/1; Loperamide hydrochloride 2 mg/1	TabletOral	IMO-GEN LABS LLC	84441-713	84441-0713-10
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	FSA store INC	81522-325	81522-0325-24
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	WALMART INC.	79903-223	79903-0223-1279903-0223-24
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Better Living Brands, LLC	21130-222	21130-0222-2421130-0222-76
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Granules India Ltd	62207-739	62207-0739-69
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	WALGREEN CO.	0363-9606	00363-9606-7500363-9606-76
Loperamide hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Bionpharma Inc.	69452-210	69452-0210-0469452-0210-12
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	NORTHEAST PHARMA	80136-384	80136-0384-24

All 14 Loperamide Hydrochloride and Simethicone NDCs

Other NDCs under ANDA 211059

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

FDA NDC Directory listings under ANDA 211059
Product	Strength	Form · route	Labeler	Product NDC
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	WALGREEN CO.	0363-9606
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Better Living Brands, LLC	21130-222
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Aurohealth LLC	58602-815
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Aurohealth LLC	58602-868
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	Aurohealth LLC	58602-869
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	WALMART INC.	79903-223
Loperamide Hydrochloride and Simethicone	Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1	TabletOral	NORTHEAST PHARMA	80136-384