FDA.reportPublic FDA data

Famotidine

Product NDC
71335-0370
11-digit product format
713350370
Labeler code
71335
Product ID
71335-0370_337a85de-6910-03aa-e063-6294a90a2e71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206530
Marketing category
ANDA
Marketing start
2015-12-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui310273

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0370-1Famotidine30 in 1 BOTTLETABLET, FILM COATED306
71335-0370-2Famotidine60 in 1 BOTTLETABLET, FILM COATED606
71335-0370-3Famotidine20 in 1 BOTTLETABLET, FILM COATED206
71335-0370-4Famotidine90 in 1 BOTTLETABLET, FILM COATED906
71335-0370-5Famotidine100 in 1 BOTTLETABLET, FILM COATED1006
71335-0370-6Famotidine10 in 1 BOTTLETABLET, FILM COATED106
71335-0370-7Famotidine120 in 1 BOTTLETABLET, FILM COATED1206
71335-0370-8Famotidine50 in 1 BOTTLETABLET, FILM COATED506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0370-1EA - Each71335-03704b9b4e51-a9ce-4fd6-97d6-7a5369d4e01312018-02-20
71335-0370-2EA - Each71335-037036b8f375-b31d-4040-9c97-c99971b9864e12018-02-20
71335-0370-3EA - Each71335-03707e37ac03-ac53-4ce1-97d3-670c88be28c812018-02-20
71335-0370-4EA - Each71335-037013199aa1-07f0-45a4-af85-0418992bb96e12018-02-20
71335-0370-5EA - Each71335-037070eac338-a94d-40d3-bf1a-89fce7061c4a12018-02-20
71335-0370-6EA - Each71335-037041e9cfad-02f2-4ef5-8f3c-cc6619899d5612018-02-20
71335-0370-7EA - Each71335-0370e03c2c09-991d-4844-a106-22165c3a7e2c12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0370FAMOTIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 8 package rows20250425_11ce2a78-76ce-44df-afe3-57493498e596.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN11ce2a78-76ce-44df-afe3-57493498e5966
310273famotidine 20 MG Oral TabletSCD11ce2a78-76ce-44df-afe3-57493498e5966

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0370-17133503700130 TABLET, FILM COATED in 1 BOTTLE (71335-0370-1) 2021-04-160000-00-00NoNoCurrent
71335-0370-27133503700260 TABLET, FILM COATED in 1 BOTTLE (71335-0370-2) 2021-07-230000-00-00NoNoCurrent
71335-0370-37133503700320 TABLET, FILM COATED in 1 BOTTLE (71335-0370-3) 2021-12-270000-00-00NoNoCurrent
71335-0370-47133503700490 TABLET, FILM COATED in 1 BOTTLE (71335-0370-4) 2021-05-040000-00-00NoNoCurrent
71335-0370-571335037005100 TABLET, FILM COATED in 1 BOTTLE (71335-0370-5) 2021-12-270000-00-00NoNoCurrent
71335-0370-67133503700610 TABLET, FILM COATED in 1 BOTTLE (71335-0370-6) 2021-06-290000-00-00NoNoCurrent
71335-0370-771335037007120 TABLET, FILM COATED in 1 BOTTLE (71335-0370-7) 2021-09-020000-00-00NoNoCurrent
71335-0370-87133503700850 TABLET, FILM COATED in 1 BOTTLE (71335-0370-8) 2021-12-270000-00-00NoNoCurrent