FDA.reportPublic FDA data

Famotidine

Product NDC
63629-2782
11-digit product format
636292782
Labeler code
63629
Product ID
63629-2782_2e1e4581-a001-42fd-98f1-91ce454823ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075805
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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-2782-12020-10-16C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-22020-10-16C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-32020-10-16C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-42020-10-16C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-52020-10-16C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-62020-10-16C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-12020-01-31C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-22020-01-31C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-32020-01-31C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-42020-01-31C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-52020-01-31C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-62020-01-31C16284748780-19d75b9d0-5f8f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2782-1Famotidine30 in 1 BOTTLETABLET3010
63629-2782-2Famotidine60 in 1 BOTTLETABLET6010
63629-2782-3Famotidine100 in 1 BOTTLETABLET10010
63629-2782-4Famotidine90 in 1 BOTTLETABLET9010
63629-2782-5Famotidine15 in 1 BOTTLETABLET1510
63629-2782-6Famotidine120 in 1 BOTTLETABLET12010
63629-2782-7Famotidine20 in 1 BOTTLETABLET2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2782-1EA - Each63629-27827b32f5c8-5bec-448f-bd61-e57fd2574d2512012-07-24
63629-2782-2EA - Each63629-2782260621be-d6cc-40ed-98f9-06affe7018e612012-07-24
63629-2782-3EA - Each63629-27822fa4a2d6-4f4c-4a7b-ba7b-cfd4f137fa1412012-07-24
63629-2782-4EA - Each63629-27828b8309da-05a2-48e7-b15b-a8f7f5cc961112021-01-08
63629-2782-5EA - Each63629-2782ddde91e8-0cb1-49d5-aa4e-1a242ff0285512021-01-08
63629-2782-6EA - Each63629-27820d9cc486-6eae-473a-bdc7-ee76cd63234a12021-01-08
63629-2782-7EA - Each63629-278267afdfdc-2466-4b5b-bd32-fb1155ca7d6112024-10-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
TRIACETININACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2782FAMOTIDINE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 7 package rows20240912_81f24752-3474-3013-0013-5570c8e7baf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN81f24752-3474-3013-0013-5570c8e7baf710
284245famotidine 40 MG Oral TabletPSN81f24752-3474-3013-0013-5570c8e7baf710
310273famotidine 20 MG Oral TabletSCD81f24752-3474-3013-0013-5570c8e7baf710
284245famotidine 40 MG Oral TabletSCD81f24752-3474-3013-0013-5570c8e7baf710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2782-16362927820130 TABLET in 1 BOTTLE (63629-2782-1) 30 tablet2005-03-140000-00-00NoNoCurrent
63629-2782-26362927820260 TABLET in 1 BOTTLE (63629-2782-2) 60 tablet2007-06-260000-00-00NoNoCurrent
63629-2782-363629278203100 TABLET in 1 BOTTLE (63629-2782-3) 100 tablet2007-07-160000-00-00NoNoCurrent
63629-2782-46362927820490 TABLET in 1 BOTTLE (63629-2782-4) 90 tablet2010-12-140000-00-00NoNoCurrent
63629-2782-56362927820515 TABLET in 1 BOTTLE (63629-2782-5) 15 tablet2013-02-040000-00-00NoNoCurrent
63629-2782-663629278206120 TABLET in 1 BOTTLE (63629-2782-6) 120 tablet2015-05-040000-00-00NoNoCurrent
63629-2782-76362927820720 TABLET in 1 BOTTLE (63629-2782-7) 20 tablet2024-09-05NoNoHistorical