FDA.reportPublic FDA data

Famotidine

Product NDC
63629-7013
11-digit product format
636297013
Labeler code
63629
Product ID
63629-7013_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
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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7013-12020-10-16C16284748780-19d75b9d0-5f8f-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
63629-7013-22020-10-16C16284748780-19d75b9d0-5f8f-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
63629-7013-32020-10-16C16284748780-19d75b9d0-5f8f-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
63629-7013-42020-10-16C16284748780-19d75b9d0-5f8f-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
63629-7013-12020-01-31C16284748780-19d75b9d0-5f8f-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
63629-7013-22020-01-31C16284748780-19d75b9d0-5f8f-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
63629-7013-32020-01-31C16284748780-19d75b9d0-5f8f-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
63629-7013-42020-01-31C16284748780-19d75b9d0-5f8f-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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7013-1Famotidine30 in 1 BOTTLETABLET3010
63629-7013-2Famotidine60 in 1 BOTTLETABLET6010
63629-7013-3Famotidine90 in 1 BOTTLETABLET9010
63629-7013-4Famotidine10 in 1 BOTTLETABLET1010
63629-7013-5Famotidine20 in 1 BOTTLETABLET2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7013-1EA - Each63629-7013ebaa38cf-61d1-447f-82c5-4f46b7d61bfd12017-08-11
63629-7013-2EA - Each63629-7013e703315b-531d-48cc-a119-cbf4dc817e0a12017-08-11
63629-7013-3EA - Each63629-7013c913ac6c-f037-41f1-b0cf-840a0b7733c112017-08-11
63629-7013-4EA - Each63629-7013e0fbc57e-f64e-45f5-b016-c38e5e77ccd412017-08-11

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
63629-7013FAMOTIDINE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 5 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 startSampleExclude flagStatus
63629-7013-16362970130130 TABLET in 1 BOTTLE (63629-7013-1) 30 tablet2005-03-14NoNoHistorical
63629-7013-26362970130260 TABLET in 1 BOTTLE (63629-7013-2) 60 tablet2007-06-26NoNoHistorical
63629-7013-36362970130390 TABLET in 1 BOTTLE (63629-7013-3) 90 tablet2007-07-16NoNoHistorical
63629-7013-46362970130410 TABLET in 1 BOTTLE (63629-7013-4) 10 tablet2010-12-14NoNoHistorical
63629-7013-56362970130520 TABLET in 1 BOTTLE (63629-7013-5) 20 tablet2013-02-04NoNoHistorical