FDA.reportPublic FDA data

Famotidine

Product NDC
55111-396
11-digit product format
551110396
Labeler code
55111
Product ID
55111-396_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
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
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
55111-396-01EA - Each55111-396014c7729-02a3-4e5b-946d-9e53c2af174b12021-04-08

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
55111-396FAMOTIDINE 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
55111-396-01551110396011 BOTTLE in 1 CARTON (55111-396-01) / 100 TABLET in 1 BOTTLE1 bottle2006-09-30NoNoCurrent
55111-396-08551110396081 BLISTER PACK in 1 CARTON (55111-396-08) / 8 TABLET in 1 BLISTER PACK1 blister pack2006-09-300000-00-00NoNoCurrent
55111-396-13551110396131 BOTTLE in 1 CARTON (55111-396-13) / 130 TABLET in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent
55111-396-16551110396165 BLISTER PACK in 1 CARTON (55111-396-16) / 5 TABLET in 1 BLISTER PACK5 blister pack2006-09-300000-00-00NoNoCurrent
55111-396-32551110396321 BOTTLE in 1 CARTON (55111-396-32) / 170 TABLET in 1 BOTTLE1 bottle2006-09-300000-00-00NoNoCurrent
55111-396-35551110396351 BOTTLE in 1 CARTON (55111-396-35) / 25 TABLET in 1 BOTTLE1 bottle2006-09-300000-00-00NoNoCurrent
55111-396-44551110396442 BOTTLE in 1 CARTON (55111-396-44) / 100 TABLET in 1 BOTTLE2 bottle2006-09-300000-00-00NoNoCurrent
55111-396-50551110396501 BOTTLE in 1 CARTON (55111-396-50) / 50 TABLET in 1 BOTTLE1 bottle2006-09-300000-00-00NoNoCurrent
55111-396-65551110396651 BOTTLE in 1 CARTON (55111-396-65) / 65 TABLET in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent
55111-396-90551110396901 BOTTLE in 1 CARTON (55111-396-90) / 90 TABLET in 1 BOTTLE1 bottle2021-10-070000-00-00NoNoCurrent
55111-396-96551110396967500 TABLET in 1 POUCH (55111-396-96)7500 tablet09-OCT-20Current