Famotidine

Product NDC
55111-118
11-digit product format
551110118
Labeler code
55111
Product ID
55111-118_e818465f-a1ca-0e6a-f18c-cf2cb2a2cc82
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Dr.Reddys Laboratories Limited
Application
ANDA077367
Marketing category
ANDA
Marketing start
2006-09-30
Substance
FAMOTIDINE
Active strength
10 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
FAMOTIDINE10 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-118-90EA - Each55111-118b0358378-0ed2-4912-b058-89e7e6d918f712021-04-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-118FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]13Current NDC, Legacy NDC20240727_387088a6-8eaa-fc49-8050-a546d0f0fd32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN387088a6-8eaa-fc49-8050-a546d0f0fd3214
310273famotidine 20 MG Oral TabletPSN387088a6-8eaa-fc49-8050-a546d0f0fd3214
199047famotidine 10 MG Oral TabletSCD387088a6-8eaa-fc49-8050-a546d0f0fd3214
310273famotidine 20 MG Oral TabletSCD387088a6-8eaa-fc49-8050-a546d0f0fd3214
199047famotidine 10 MG Oral TabletPSNca039876-f7e5-3e60-da5a-a1f40637a4179
310273famotidine 20 MG Oral TabletPSNca039876-f7e5-3e60-da5a-a1f40637a4179
199047famotidine 10 MG Oral TabletSCDca039876-f7e5-3e60-da5a-a1f40637a4179
310273famotidine 20 MG Oral TabletSCDca039876-f7e5-3e60-da5a-a1f40637a4179
199047famotidine 10 MG Oral TabletPSNc5d81352-c45b-3ea1-9974-8a096bd050097
310273famotidine 20 MG Oral TabletPSNc5d81352-c45b-3ea1-9974-8a096bd050097
199047famotidine 10 MG Oral TabletSCDc5d81352-c45b-3ea1-9974-8a096bd050097
310273famotidine 20 MG Oral TabletSCDc5d81352-c45b-3ea1-9974-8a096bd050097
199047famotidine 10 MG Oral TabletPSN1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
310273famotidine 20 MG Oral TabletPSN1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
199047famotidine 10 MG Oral TabletSCD1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
310273famotidine 20 MG Oral TabletSCD1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
199047famotidine 10 MG Oral TabletPSN7fbc5e10-30c6-7f8d-1040-d48a80fe4d792
310273famotidine 20 MG Oral TabletPSN7fbc5e10-30c6-7f8d-1040-d48a80fe4d792
199047famotidine 10 MG Oral TabletSCD7fbc5e10-30c6-7f8d-1040-d48a80fe4d792
310273famotidine 20 MG Oral TabletSCD7fbc5e10-30c6-7f8d-1040-d48a80fe4d792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-118-04551110118041 BOTTLE in 1 CARTON (55111-118-04) / 120 TABLET in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent
55111-118-12551110118121 BLISTER PACK in 1 CARTON (55111-118-12) / 12 TABLET in 1 BLISTER PACK1 blister pack2006-09-300000-00-00NoNoCurrent
55111-118-18551110118181 BOTTLE in 1 CARTON (55111-118-18) / 180 TABLET in 1 BOTTLE1 bottle2006-09-300000-00-00NoNoCurrent
55111-118-24551110118244 BLISTER PACK in 1 CARTON (55111-118-24) / 6 TABLET in 1 BLISTER PACK4 blister pack2006-09-300000-00-00NoNoCurrent
55111-118-30551110118301 BOTTLE in 1 CARTON (55111-118-30) / 30 TABLET in 1 BOTTLE1 bottle2006-09-300000-00-00NoNoCurrent
55111-118-35551110118353 BLISTER PACK in 1 CARTON (55111-118-35) / 6 TABLET in 1 BLISTER PACK3 blister pack2006-09-300000-00-00NoNoCurrent
55111-118-40551110118401 BOTTLE in 1 CARTON (55111-118-40) / 40 TABLET in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent
55111-118-60551110118601 BOTTLE in 1 CARTON (55111-118-60) / 60 TABLET in 1 BOTTLE1 bottle2006-09-300000-00-00NoNoCurrent
55111-118-79551110118791 BLISTER PACK in 1 CARTON (55111-118-79) / 10 TABLET in 1 BLISTER PACK1 blister pack2006-09-300000-00-00NoNoCurrent
55111-118-81551110118813 BLISTER PACK in 1 CARTON (55111-118-81) / 10 TABLET in 1 BLISTER PACK3 blister pack2006-09-300000-00-00NoNoCurrent
55111-118-90551110118901 BOTTLE in 1 CARTON (55111-118-90) / 90 TABLET in 1 BOTTLE1 bottle2006-09-300000-00-00NoNoCurrent
55111-118-985511101189820000 TABLET in 1 POUCH (55111-118-98)20000 tablet09-OCT-20Current