NDC codes

FDA NDC Directory
Product NDC (as listed)41163-553Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41163-0553Add 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 NDC11-digit (billing)PackageCopy
41163-553-89411630553894116305538918 BLISTER PACK in 1 CARTON (41163-553-89) / 1 TABLET in 1 BLISTER PACKMarketed from Dec 4, 2019

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

Generic name (nonproprietary)
loperamide hydrochloride, simethicone
Active ingredients
Loperamide hydrochloride — 2 mg/1Dimethicone — 125 mg/1
Dosage form
Tablet
Route
Oral
Labeler
United Natural Foods, Inc. dba UNFINDC labeler code 41163
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209837
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)Skin Barrier Activity (Physiologic effect)
Identifiers
Product ID 41163-553_a742181e-c26b-47b9-9d0d-218942b28150SPL ID a742181e-c26b-47b9-9d0d-218942b28150SPL set ID 2ce0b37e-6dc4-423f-a1d6-a2cb623946d5RxCUI 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

N441163055389 followed by a unit qualifier and the quantity

Package 41163-0553-89. 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 .

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 41163-553

What is NDC 41163-553?
41163-553 is the product NDC for equaline anti diarrheal plus anti gas, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by United Natural Foods, Inc. dba UNFI. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
equaline anti diarrheal plus anti gas (Loperamide hydrochloride, simethicone).
What is the active ingredient?
Loperamide hydrochloride, Dimethicone.
Who is the labeler?
United Natural Foods, Inc. dba UNFI, NDC labeler code 41163. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for equaline anti diarrheal plus anti gas?
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 209837

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

FDA NDC Directory listings under ANDA 209837
ProductStrengthForm · routeLabelerProduct NDC
anti diarrheal and anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralWalgreen Company0363-1830
anti diarrheal and anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralCVS Pharmacy69842-644
anti diarrheal anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralRite Aid Corporation11822-1003
Anti Diarrheal Anti Gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralKroger Company30142-581
anti diarrheal anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralH E B37808-714
anti diarrheal anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralHyVee Inc42507-699
anti diarrheal plus anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralMeijer Distribution Inc41250-375
Basic Care Loperamide Hydrochloride and Simethiconeloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralAmazon.com Services LLC72288-001
CareOne Diarrhea and Gas Controlloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralAmerican Sales Company41520-772
dg health anti diarrheal anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralDolgencorp, LLC55910-383
foster and thrive anti diarrheal anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralStrategic Sourcing Services LLC70677-1105
good neighbor pharmacy anti diarrheal anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralAmerisource Bergen46122-620
good sense anti diarrheal anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralL. Perrigo Company0113-0087
Good Sense Anti Diarrheal Anti Gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralL. Perrigo Company0113-1087
loperamide hydrochloride and simethiconeloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralAmazon.com Services LLC72288-728
signature care anti diarrheal anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralSafeway21130-183
up and up anti diarrheal anti gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralTarget Corporation11673-646

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