FDA.reportPublic FDA data

Famotidine

Product NDC
51407-683
11-digit product format
514070683
Labeler code
51407
Product ID
51407-683_22941e23-59e9-f792-e063-6394a90a2552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
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
Rxcui284245, 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
51407-683-10Famotidine1000 in 1 BOTTLETABLET10003
51407-683-10Famotidine36 in 1 BOXTABLET363
51407-683-18Famotidine180 in 1 BOTTLETABLET1803
51407-683-18Famotidine36 in 1 BOXTABLET363
51407-683-25Famotidine25 in 1 BOTTLETABLET253
51407-683-25Famotidine36 in 1 BOXTABLET363
51407-683-30Famotidine36 in 1 BOXTABLET363
51407-683-30Famotidine30 in 1 BOTTLETABLET303
51407-683-50Famotidine50 in 1 BOTTLETABLET503
51407-683-50Famotidine36 in 1 BOXTABLET363
51407-683-90Famotidine36 in 1 BOXTABLET363
51407-683-90Famotidine90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-683FAMOTIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, 12 package rows20241027_f67bcbc7-952c-61c0-e053-2a95a90a6fa6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNf67bcbc7-952c-61c0-e053-2a95a90a6fa63
284245famotidine 40 MG Oral TabletPSNf67bcbc7-952c-61c0-e053-2a95a90a6fa63
310273famotidine 20 MG Oral TabletSCDf67bcbc7-952c-61c0-e053-2a95a90a6fa63
284245famotidine 40 MG Oral TabletSCDf67bcbc7-952c-61c0-e053-2a95a90a6fa63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-683-105140706831036 BOTTLE in 1 BOX (51407-683-10) / 1000 TABLET in 1 BOTTLE36 bottle2023-03-08NoNoCurrent
51407-683-185140706831836 BOTTLE in 1 BOX (51407-683-18) / 180 TABLET in 1 BOTTLE36 bottle2023-03-08NoNoCurrent
51407-683-255140706832536 BOTTLE in 1 BOX (51407-683-25) / 25 TABLET in 1 BOTTLE36 bottle2023-03-08NoNoCurrent
51407-683-305140706833036 BOTTLE in 1 BOX (51407-683-30) / 30 TABLET in 1 BOTTLE36 bottle2023-03-08NoNoCurrent
51407-683-505140706835036 BOTTLE in 1 BOX (51407-683-50) / 50 TABLET in 1 BOTTLE36 bottle2023-03-08NoNoCurrent
51407-683-905140706839036 BOTTLE in 1 BOX (51407-683-90) / 90 TABLET in 1 BOTTLE36 bottle2023-03-08NoNoCurrent