FDA.reportPublic FDA data

Famotidine

Product NDC
55111-120
11-digit product format
551110120
Labeler code
55111
Product ID
55111-120_b30502a9-c0c8-909c-ec34-956a5e058223
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA075718
Marketing category
ANDA
Marketing start
2001-04-16
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
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
55111-120-01Famotidine100 in 1 BOTTLETABLET, FILM COATED1008
55111-120-10Famotidine1000 in 1 BOTTLETABLET, FILM COATED10008
55111-120-30Famotidine30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-120-01EA - Each55111-120da411d06-13fc-4981-a62f-6549cbcf547d12012-07-24
55111-120-10EA - Each55111-120272d99da-b533-45f0-9164-22b0e635133612012-07-24
55111-120-30EA - Each55111-12057734fcd-25c4-457e-8dc0-f44758eebca412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
famotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
famotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
famotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
famotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE (FAMOTIDINE ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-120FAMOTIDINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]8Current NDC, Legacy NDC, 3 package rows20210528_06d286ce-14b3-4b66-8b42-ac4a10a0fc90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN06d286ce-14b3-4b66-8b42-ac4a10a0fc908
284245famotidine 40 MG Oral TabletPSN06d286ce-14b3-4b66-8b42-ac4a10a0fc908
310273famotidine 20 MG Oral TabletSCD06d286ce-14b3-4b66-8b42-ac4a10a0fc908
284245famotidine 40 MG Oral TabletSCD06d286ce-14b3-4b66-8b42-ac4a10a0fc908
310273famotidine 20 MG Oral TabletPSNf1fc14d1-e11d-4fe6-996f-a775ec675bb23
284245famotidine 40 MG Oral TabletPSNf1fc14d1-e11d-4fe6-996f-a775ec675bb23
310273famotidine 20 MG Oral TabletSCDf1fc14d1-e11d-4fe6-996f-a775ec675bb23
284245famotidine 40 MG Oral TabletSCDf1fc14d1-e11d-4fe6-996f-a775ec675bb23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55111-120-0155111012001100 TABLET, FILM COATED in 1 BOTTLE (55111-120-01) 2001-04-160000-00-00NoNoCurrent
55111-120-10551110120101000 TABLET, FILM COATED in 1 BOTTLE (55111-120-10) 2001-04-160000-00-00NoNoCurrent
55111-120-305511101203030 TABLET, FILM COATED in 1 BOTTLE (55111-120-30) 2001-04-160000-00-00NoNoCurrent