Over-the-counter drug · ANDA

topcare acid reducer (famotidine) NDC 76162-300

Famotidine 20 mg/1 · Tablet, Film coated · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)76162-300Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76162-0300Add 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
76162-300-71761620300711 BOTTLE in 1 CARTON (76162-300-71) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 25, 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

Brand name (proprietary)
topcare acid reducer
Generic name (nonproprietary)
famotidine
Active ingredients
Famotidine — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077351
Marketing start
Listing expires
Other FDA classes
Histamine H2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 76162-300_8a5a69da-3a67-4ecc-97d1-39ffea001485SPL ID 8a5a69da-3a67-4ecc-97d1-39ffea001485SPL set ID 7824fdab-cdd5-457d-9b14-b82b19ea9529RxCUI 310273UNII 5QZO15J2Z8

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

N476162030071 followed by a unit qualifier and the quantity

Package 76162-0300-71. 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 heartburn associated with acid indigestion and sour stomach • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077351

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

FDA NDC Directory listings under ANDA 077351
ProductStrengthForm · routeLabelerProduct NDC
equaline heartburn preventionfamotidineFamotidine 20 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-001
careone acid relieffamotidineFamotidine 20 mg/1Tablet, Film coatedOralRetail Business Services, LLC72476-150
heartburn relieffamotidineFamotidine 20 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-712
acid controllerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralSafeway21130-521
acid controllerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralCVS Pharmacy59779-194
CareOne Acid RelieffamotidineFamotidine 20 mg/1Tablet, Film coatedOralAmerican Sales Company41520-707
Equate FamotidinefamotidineFamotidine 20 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-650
kirkland signature acid controllerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralCostco Wholesale Company63981-194
Good Sense Acid ReducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralL. Perrigo Company0113-0194
Acid ControllerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralH E B59640-001
acid reducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralH E B59640-023
Rugby FamotidinefamotidineFamotidine 20 mg/1Tablet, Film coatedOralRugby Laboratories0536-1298
Acid ReducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-088
foster and thrive acid reducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1101
basic care heartburn preventionfamotidineFamotidine 20 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-151
heartburn preventionfamotidineFamotidine 20 mg/1Tablet, Film coatedOralKroger Company30142-194
basic care acid reducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-194
maximum strengthfamotidineFamotidine 20 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-194
acid relieffamotidineFamotidine 20 mg/1Tablet, Film coatedOralRite Aid Corporation11822-6123
dg health heartburn preventionfamotidineFamotidine 20 mg/1Tablet, Film coatedOralDolgencorp Inc55910-665

Showing 20 of 39.

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