FDA.reportPublic FDA data

Famotidine

Product NDC
50268-304
11-digit product format
502680304
Labeler code
50268
Product ID
50268-304_4358a0ea-0bd3-406d-e063-6394a90ade47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA075805
Marketing category
ANDA
Marketing start
2014-10-06
Substance
FAMOTIDINE
Active strength
40 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
FAMOTIDINE40 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
50268-304-11Famotidine1 in 1 BLISTER PACKTABLET17
50268-304-15Famotidine50 in 1 BOX, UNIT-DOSETABLET507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-304-11EA - Each50268-304e462889b-f645-4865-bbd5-3c521f1d7b8e12015-04-03
50268-304-15EA - Each50268-30404c16f3f-b7a0-4975-b5cd-755c510bbde912015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
FamotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
magnesium stearateINACTIVE INGREDIENT70097M6I30FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
starch, cornINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
talcINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
triacetinINACTIVE INGREDIENTXHX3C3X673FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-304FAMOTIDINE TABLET [AVPAK]6Current NDC, Legacy NDC, 2 package rows20240502_85c7d20d-3dec-b918-4c1d-8ca1db214e48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN85c7d20d-3dec-b918-4c1d-8ca1db214e487
284245famotidine 40 MG Oral TabletPSN85c7d20d-3dec-b918-4c1d-8ca1db214e487
310273famotidine 20 MG Oral TabletSCD85c7d20d-3dec-b918-4c1d-8ca1db214e487
284245famotidine 40 MG Oral TabletSCD85c7d20d-3dec-b918-4c1d-8ca1db214e487

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-304-11502680304111 in 1 BLISTER PACKHistorical
50268-304-155026803041550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-304-15) / 1 TABLET in 1 BLISTER PACK (50268-304-11) 50 blister pack2014-10-060000-00-00NoNoCurrent