Over-the-counter drug · ANDA

Leader Acid Reducer (Famotidine) NDC 70000-0654

Famotidine 20 mg/1 · Tablet, Film coated · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0654Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0654Add 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
70000-0654-170000065401700000654011 BOTTLE in 1 CARTON (70000-0654-1) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 25, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Leader Acid Reducer
Generic name (nonproprietary)
famotidine
Active ingredients
Famotidine — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
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 70000-0654_563bca3a-1a43-4520-ac66-3aecd0d3c5fdSPL ID 563bca3a-1a43-4520-ac66-3aecd0d3c5fdSPL set ID 321b83f9-4bbf-494a-9279-80b0742049b6RxCUI 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

N470000065401 followed by a unit qualifier and the quantity

Package 70000-0654-01. 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)

About NDC 70000-0654

What is NDC 70000-0654?
70000-0654 is the product NDC for Leader Acid Reducer (famotidine), Famotidine 20 mg/1 tablet, film coated, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Leader Acid Reducer (Famotidine).
What is the active ingredient?
Famotidine.
Who is the labeler?
Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Leader Acid Reducer?
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 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
dg health heartburn preventionfamotidineFamotidine 20 mg/1Tablet, Film coatedOralDolgencorp Inc55910-665
careone acid relieffamotidineFamotidine 20 mg/1Tablet, Film coatedOralRetail Business Services, LLC72476-299
acid controllerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralWalgreen Company0363-1203
heartburn relieffamotidineFamotidine 20 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-712
basic care heartburn preventionfamotidineFamotidine 20 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-151
Acid ReducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-511
CareOne Acid RelieffamotidineFamotidine 20 mg/1Tablet, Film coatedOralAmerican Sales Company41520-707
basic care acid reducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-194
acid reducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralCVS Pharmacy69842-659
equate famotidinefamotidineFamotidine 20 mg/1Tablet, Film coatedOralWALMART INC.79903-115
Rolaids ACID DEFENSEfamotitineFamotidine 20 mg/1TabletOralThe Procter & Gamble Manufacturing Company84126-367
dg health acid reducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralDolgencorp Inc55910-814
dg health heartburn preventionfamotidineFamotidine 20 mg/1Tablet, Film coatedOralDolgencorp Inc55910-194
Acid ControllerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralWalgreen Company0363-0701
FamotidineFamotidine 20 mg/1Tablet, Film coatedOralPrecision Dose, Inc.68094-054
members mark acid pepfamotidineFamotidine 20 mg/1Tablet, Film coatedOralSam's West Inc68196-121
berkley and jensen famotidinefamotidineFamotidine 20 mg/1Tablet, Film coatedOralBJWC68391-300
heartburn preventionfamotidineFamotidine 20 mg/1Tablet, Film coatedOralKroger Company30142-194
basic care acid reducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-329
Equate FamotidinefamotidineFamotidine 20 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-650

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