NDC codes

FDA NDC Directory
Product NDC (as listed)79903-116Labeler and product segments. Claims need a package NDC.
Product NDC at billing width79903-0116Add 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
79903-116-3379903011633799030116334 BLISTER PACK in 1 CARTON (79903-116-33) / 6 TABLET in 1 BLISTER PACKMarketed from Jul 15, 2022

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 2mg, simethicone 125mg
Active ingredients
Loperamide hydrochloride — 2 mg/1Dimethicone — 125 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Wal-Mart Stores, Inc.NDC labeler code 79903
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214541
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)Skin Barrier Activity (Physiologic effect)
Identifiers
Product ID 79903-116_f6ae2fa7-3ea7-4643-8bce-75b3a4f2558fSPL ID f6ae2fa7-3ea7-4643-8bce-75b3a4f2558fSPL set ID a4d5dd69-22cf-4d00-b539-133886c09e37RxCUI 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

N479903011633 followed by a unit qualifier and the quantity

Package 79903-0116-33. 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)

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 79903-116

What is NDC 79903-116?
79903-116 is the product NDC for Anti-Diarrheal/Anti-Gas Multi-Symptom Relief, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by Wal-Mart Stores, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Anti-Diarrheal/Anti-Gas Multi-Symptom Relief (Loperamide Hydrochloride 2mg, Simethicone 125mg).
What is the active ingredient?
Loperamide hydrochloride, Dimethicone.
Who is the labeler?
Wal-Mart Stores, Inc., NDC labeler code 79903. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Anti-Diarrheal/Anti-Gas Multi-Symptom Relief?
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
ProductStrengthForm · routeLabelerProduct NDC
Anti-Diarrheal/Anti-Gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralDiscount Drug Mart, Inc53943-263
Anti-Diarrheal/Anti-Gasloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralHarris Teeter, LLC69256-265
Equate Anti Diarrheal Anti Gas Multi-Symptom Reliefloperamide hydrochloride, simethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralWALMART INC.79903-302
Loperamide Hydrochloride, SimethiconeLoperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1TabletOralGuardian Drug Company53041-263

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