FDA.reportPublic FDA data

Famotidine

Product NDC
0172-5728
11-digit product format
001725728
Labeler code
0172
Product ID
0172-5728_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
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
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
0172-5728-60Famotidine100 in 1 BOTTLETABLET, FILM COATED10020
0172-5728-70Famotidine500 in 1 BOTTLETABLET, FILM COATED50020
0172-5728-80Famotidine1000 in 1 BOTTLETABLET, FILM COATED100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0172-5728-00EA - Each0172-572866be047d-beaa-49eb-a159-337d871c552812012-07-24
0172-5728-10EA - Each0172-57280507c0b7-41e9-4723-a25c-6f2515e6491112012-07-24
0172-5728-60EA - Each0172-5728f141be7e-c8da-46b9-bf6c-a837184af23e12012-07-24
0172-5728-70EA - Each0172-57282c2e8b79-4183-40dd-8878-2dac30f3361f12012-07-24
0172-5728-80EA - Each0172-5728a312a8fb-5455-4f8a-928f-87f28cb517d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0172-5728FAMOTIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]20Current NDC, Legacy NDC, 3 package rows20240601_4c6f4f9e-f3f5-4ecf-9f40-887e037e8847.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
310273famotidine 20 MG Oral TabletPSN277050eb-3e7e-1919-e054-00144ff88e888
310273famotidine 20 MG Oral TabletPSNd60bde93-f512-4071-9e4b-1d8318def3bc8
310273famotidine 20 MG Oral TabletSCDd60bde93-f512-4071-9e4b-1d8318def3bc8
310273famotidine 20 MG Oral TabletSCD277050eb-3e7e-1919-e054-00144ff88e888
310273famotidine 20 MG Oral TabletPSN886287cf-a6f7-6770-e053-2a95a90a21bb7
310273famotidine 20 MG Oral TabletSCD886287cf-a6f7-6770-e053-2a95a90a21bb7
310273famotidine 20 MG Oral TabletPSN5c583c02-e122-4faa-bf34-0632c62784c76
310273famotidine 20 MG Oral TabletSCD5c583c02-e122-4faa-bf34-0632c62784c76
310273famotidine 20 MG Oral TabletPSN74ff64f2-d882-411f-bac8-29dfa4cb4f105
310273famotidine 20 MG Oral TabletSCD74ff64f2-d882-411f-bac8-29dfa4cb4f105
310273famotidine 20 MG Oral TabletPSN7dc845a4-d0dd-41c5-e053-2a91aa0ae5b33
310273famotidine 20 MG Oral TabletSCD7dc845a4-d0dd-41c5-e053-2a91aa0ae5b33
310273famotidine 20 MG Oral TabletPSN4748eb92-efeb-48ae-967c-605ce7cff11f2
310273famotidine 20 MG Oral TabletPSNf2b6da72-72ea-d81b-e053-2995a90a95262
310273famotidine 20 MG Oral TabletPSN599f4348-122c-adc9-e053-2a91aa0acd212
310273famotidine 20 MG Oral TabletSCDf2b6da72-72ea-d81b-e053-2995a90a95262
310273famotidine 20 MG Oral TabletSCD599f4348-122c-adc9-e053-2a91aa0acd212
310273famotidine 20 MG Oral TabletSCD4748eb92-efeb-48ae-967c-605ce7cff11f2
310273famotidine 20 MG Oral TabletPSN492241f8-9dad-453a-a996-50ce67d0812a1
310273famotidine 20 MG Oral TabletPSN2bde8e1d-078f-4ba1-9ccb-29de6e36d8c41
310273famotidine 20 MG Oral TabletSCD492241f8-9dad-453a-a996-50ce67d0812a1
310273famotidine 20 MG Oral TabletSCD2bde8e1d-078f-4ba1-9ccb-29de6e36d8c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0172-5728-6000172572860100 TABLET, FILM COATED in 1 BOTTLE (0172-5728-60) 2001-04-160000-00-00NoNoCurrent
0172-5728-7000172572870500 TABLET, FILM COATED in 1 BOTTLE (0172-5728-70) 2001-04-160000-00-00NoNoCurrent
0172-5728-80001725728801000 TABLET, FILM COATED in 1 BOTTLE (0172-5728-80) 2001-04-160000-00-00NoNoCurrent