FDA.reportPublic FDA data

Famotidine

Product NDC
72657-113
11-digit product format
726570113
Labeler code
72657
Product ID
72657-113_5502899d-30bd-4954-8aae-9ab1c034f65f
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GLENMARK THERAPEUTICS INC., USA
Application
ANDA215822
Marketing category
ANDA
Marketing start
2022-06-01
Substance
FAMOTIDINE
Active strength
20 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047, 310273

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72657-113-20Famotidine1 in 1 CARTONTABLET, FILM COATED14
72657-113-20Famotidine200 in 1 BOTTLETABLET, FILM COATED2004
72657-113-88Famotidine85 in 1 BOTTLETABLET, FILM COATED854
72657-113-88Famotidine1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-113-20EA - Each72657-1136ddef29c-eb34-48e0-a98c-f7efee9fae4512026-03-17
72657-113-88EA - Each72657-113c41bab95-97f7-4d75-87b5-121b0fe8b76412026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72657-113FAMOTIDINE TABLET, FILM COATED [GLENMARK THERAPEUTICS INC., USA]3Current NDC, Legacy NDC, 4 package rows20250124_95f51f27-d367-4cfd-a15f-7856c9e361fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN95f51f27-d367-4cfd-a15f-7856c9e361fb4
310273famotidine 20 MG Oral TabletPSN95f51f27-d367-4cfd-a15f-7856c9e361fb4
199047famotidine 10 MG Oral TabletSCD95f51f27-d367-4cfd-a15f-7856c9e361fb4
310273famotidine 20 MG Oral TabletSCD95f51f27-d367-4cfd-a15f-7856c9e361fb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72657-113-20726570113201 BOTTLE in 1 CARTON (72657-113-20) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-06-010000-00-00NoNoCurrent
72657-113-88726570113881 BOTTLE in 1 CARTON (72657-113-88) / 85 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-06-010000-00-00NoNoCurrent