FDA.reportPublic FDA data

Famotidine

Product NDC
0172-5729
11-digit product format
001725729
Labeler code
0172
Product ID
0172-5729_4f26d0af-7f08-49a1-8bba-46741aa83ad5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075511
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0172-5729-60Famotidine100 in 1 BOTTLETABLET, FILM COATED10020
0172-5729-70Famotidine500 in 1 BOTTLETABLET, FILM COATED50020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0172-5729-00EA - Each0172-5729e45c5118-c2f6-4bba-b35f-b7fe8145a04a12012-07-24
0172-5729-10EA - Each0172-5729e46d0ea3-60a7-4947-8009-8e79726f19df12012-07-24
0172-5729-60EA - Each0172-57291c48807e-3ef8-4158-b21e-a5eaa7150d9612012-07-24
0172-5729-70EA - Each0172-57291d99e451-87cf-467f-ac74-32f0399d703712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LFAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
TRIACETININACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]11
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [NORTHWIND PHARMACEUTICALS,LLC]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [NORTHWIND PHARMACEUTICALS,LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0172-5729FAMOTIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]20Current NDC, Legacy NDC, 2 package rows20240601_4c6f4f9e-f3f5-4ecf-9f40-887e037e8847.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSN5798d282-ce83-49aa-bc33-13203f2b528522
284245famotidine 40 MG Oral TabletSCD5798d282-ce83-49aa-bc33-13203f2b528522
310273famotidine 20 MG Oral TabletPSN4c6f4f9e-f3f5-4ecf-9f40-887e037e884720
284245famotidine 40 MG Oral TabletPSN4c6f4f9e-f3f5-4ecf-9f40-887e037e884720
310273famotidine 20 MG Oral TabletSCD4c6f4f9e-f3f5-4ecf-9f40-887e037e884720
284245famotidine 40 MG Oral TabletSCD4c6f4f9e-f3f5-4ecf-9f40-887e037e884720
284245famotidine 40 MG Oral TabletPSN03503cd5-bd8e-4bff-b90d-1a71c5225b913
284245famotidine 40 MG Oral TabletSCD03503cd5-bd8e-4bff-b90d-1a71c5225b913
284245famotidine 40 MG Oral TabletPSN04281015-44ba-6197-e063-6394a90ab36a1
284245famotidine 40 MG Oral TabletPSNfe21daca-ac48-4b46-9cb3-9a69af0c6a841
284245famotidine 40 MG Oral TabletSCD04281015-44ba-6197-e063-6394a90ab36a1
284245famotidine 40 MG Oral TabletSCDfe21daca-ac48-4b46-9cb3-9a69af0c6a841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0172-5729-6000172572960100 TABLET, FILM COATED in 1 BOTTLE (0172-5729-60) 2001-04-160000-00-00NoNoCurrent
0172-5729-7000172572970500 TABLET, FILM COATED in 1 BOTTLE (0172-5729-70) 2001-04-160000-00-00NoNoCurrent