FDA.reportPublic FDA data

FAMOTIDINE

Product NDC
61919-281
11-digit product format
619190281
Labeler code
61919
Product ID
61919-281_f2126c8d-5165-3721-e053-2995a90a1234
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075805
Marketing category
ANDA
Marketing start
2019-08-08
Marketing end
0000-00-00
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
2024-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-281-202025-01-30C16284748780-12cef2736-9ffb-d83d-e063-dadaa90ab31fFAMOTIDINE
61919-281-302025-01-30C16284748780-12cef2736-9ffb-d83d-e063-dadaa90ab31fFAMOTIDINE
61919-281-902025-01-30C16284748780-12cef2736-9ffb-d83d-e063-dadaa90ab31fFAMOTIDINE
61919-281-602023-01-30C16284748780-19d75b9d0-3514-f424-e053-dadaa90a57ceFAMOTIDINE
61919-281-602021-01-07C16284748780-19d75b9d0-3514-f424-e053-dadaa90a57ceFAMOTIDINE
61919-281-602020-01-31C16284748780-19d75b9d0-3514-f424-e053-dadaa90a57ceFAMOTIDINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-281-20FAMOTIDINE20 in 1 BOTTLETABLET208
61919-281-30FAMOTIDINE30 in 1 BOTTLETABLET308
61919-281-90FAMOTIDINE90 in 1 BOTTLETABLET908
61919-281-60FAMOTIDINE60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-281-20EA - Each61919-2810a52a646-edbb-4517-9bfc-6f8c06bc9ac412022-11-07
61919-281-30EA - Each61919-28140193657-d9a6-449f-bfad-4f9c9839b60312022-10-06
61919-281-60EA - Each61919-28108cc874f-c6c5-4ac4-9bd0-0cb6c697bf5a12014-11-05
61919-281-90EA - Each61919-28185f6187a-3216-41a2-a911-f0a227e0c28012019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [DIRECT RX]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [DIRECT RX]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [DIRECT RX]1
magnesium stearateINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [DIRECT RX]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [DIRECT RX]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [DIRECT RX]1
starch, cornINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [DIRECT RX]1
talcINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [DIRECT RX]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [DIRECT RX]1
triacetinINACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-281FAMOTIDINE TABLET [DIRECT_RX]8Legacy NDC, 3 package rows20230113_8fa16dc6-0ef1-2f48-e053-2a95a90a83ed.zip
61919-281FAMOTIDINE TABLET [DIRECT RX]4Legacy NDC, 1 package rows20210108_18959b62-4c58-40cd-837f-ff263e1ce8e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN8fa16dc6-0ef1-2f48-e053-2a95a90a83ed8
310273famotidine 20 MG Oral TabletSCD8fa16dc6-0ef1-2f48-e053-2a95a90a83ed8
310273famotidine 20 MG Oral TabletPSN18959b62-4c58-40cd-837f-ff263e1ce8e14
310273famotidine 20 MG Oral TabletSCD18959b62-4c58-40cd-837f-ff263e1ce8e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-281-206191902812020 TABLET in 1 BOTTLE (61919-281-20) 20 tablet2019-08-080000-00-00NoNoCurrent
61919-281-306191902813030 TABLET in 1 BOTTLE (61919-281-30) 30 tablet2019-08-080000-00-00NoNoCurrent
61919-281-606191902816060 TABLET in 1 BOTTLE (61919-281-60) 60 tablet2014-01-010000-00-00NoNoCurrent
61919-281-906191902819090 TABLET in 1 BOTTLE (61919-281-90) 90 tablet2019-08-080000-00-00NoNoCurrent