FDA.reportPublic FDA data

PEPCID AC

Product NDC
16837-855
11-digit product format
168370855
Labeler code
16837
Product ID
16837-855_21af0de6-18c5-b8e8-e063-6394a90af51f
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA020325
Marketing category
NDA
Marketing start
2003-09-01
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
PEPCID AC
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui104094, 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
16837-855-022024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-052024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-092024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-122024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-132024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-142024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-152024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-162024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-172024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-182024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-192024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-202024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-242024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-252024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-402024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-492024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-502024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-512024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-522024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-652024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-672024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-702024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-752024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-802024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-852024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength
16837-855-902024-01-30C16284748780-11030e365-2b49-111a-e063-dadaa90a10e2PEPCID ® AC Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16837-855-02PEPCID ACMaximum Strength2 in 1 CARTONTABLET, FILM COATED223
16837-855-02PEPCID ACMaximum Strength1 in 1 POUCHTABLET, FILM COATED123
16837-855-05PEPCID ACMaximum Strength5 in 1 BLISTER PACKTABLET, FILM COATED523
16837-855-05PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-09PEPCID ACMaximum Strength1 in 1 PACKAGETABLET, FILM COATED123
16837-855-09PEPCID ACMaximum Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10023
16837-855-12PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-12PEPCID ACMaximum Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10023
16837-855-13PEPCID ACMaximum Strength1 in 1 POUCHTABLET, FILM COATED123
16837-855-14PEPCID ACMaximum Strength5 in 1 BLISTER PACKTABLET, FILM COATED523
16837-855-14PEPCID ACMaximum Strength5 in 1 CARTONTABLET, FILM COATED523
16837-855-15PEPCID ACMaximum Strength35 in 1 BOTTLE, PLASTICTABLET, FILM COATED3523
16837-855-15PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-16PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-16PEPCID ACMaximum Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5023
16837-855-17PEPCID ACMaximum Strength65 in 1 BOTTLE, PLASTICTABLET, FILM COATED6523
16837-855-17PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-18PEPCID ACMaximum Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10023
16837-855-18PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-19PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-19PEPCID ACMaximum Strength8 in 1 BLISTER PACKTABLET, FILM COATED823
16837-855-20PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-20PEPCID ACMaximum Strength2 in 1 PACKAGETABLET, FILM COATED223
16837-855-24PEPCID ACMaximum Strength1 in 1 POUCHTABLET, FILM COATED123
16837-855-24PEPCID ACMaximum Strength2500 in 1 CARTONTABLET, FILM COATED250023
16837-855-25PEPCID ACMaximum Strength5 in 1 BLISTER PACKTABLET, FILM COATED523
16837-855-25PEPCID ACMaximum Strength5 in 1 CARTONTABLET, FILM COATED523
16837-855-40PEPCID ACMaximum Strength8 in 1 BLISTER PACKTABLET, FILM COATED823
16837-855-40PEPCID ACMaximum Strength5 in 1 CARTONTABLET, FILM COATED523
16837-855-49PEPCID ACMaximum Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5023
16837-855-49PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-50PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-50PEPCID ACMaximum Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5023
16837-855-51PEPCID ACMaximum Strength12 in 1 CARTONTABLET, FILM COATED1223
16837-855-51PEPCID ACMaximum Strength5 in 1 BLISTER PACKTABLET, FILM COATED523
16837-855-52PEPCID ACMaximum Strength50 in 1 TRAYTABLET, FILM COATED5023
16837-855-52PEPCID ACMaximum Strength1 in 1 POUCHTABLET, FILM COATED123
16837-855-65PEPCID ACMaximum Strength65 in 1 BOTTLE, PLASTICTABLET, FILM COATED6523
16837-855-65PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-67PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-67PEPCID ACMaximum Strength65 in 1 BOTTLE, PLASTICTABLET, FILM COATED6523
16837-855-70PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-70PEPCID ACMaximum Strength70 in 1 BOTTLE, PLASTICTABLET, FILM COATED7023
16837-855-75PEPCID ACMaximum Strength75 in 1 BOTTLE, PLASTICTABLET, FILM COATED7523
16837-855-75PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-80PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-80PEPCID ACMaximum Strength80 in 1 BOTTLE, PLASTICTABLET, FILM COATED8023
16837-855-85PEPCID ACMaximum Strength85 in 1 BOTTLE, PLASTICTABLET, FILM COATED8523
16837-855-85PEPCID ACMaximum Strength1 in 1 CARTONTABLET, FILM COATED123
16837-855-90PEPCID ACMaximum Strength125 in 1 PACKAGE, COMBINATIONTABLET, FILM COATED12523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16837-855-14EA - Each16837-855f235e0f8-899b-4d70-b432-965d7c89b25c12020-05-08
16837-855-20EA - Each16837-8554e0b3b00-4286-40fa-a8aa-8b200f0a17e712018-11-06
16837-855-25EA - Each16837-85589ae8e30-8f54-4a60-b156-360669f6474512018-03-08
16837-855-50EA - Each16837-85516402839-23a8-4222-905a-c7d62af2b46112018-03-08
16837-855-75EA - Each16837-855662f0682-7aa8-4682-8bad-99d851f4bb7612021-08-05
16837-855-90EA - Each16837-855a5a3e34d-e891-46b1-895f-5175a172f94e12021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FamotidineACTIVE INGREDIENT5QZO15J2Z8PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]6
FamotidineACTIVE MOIETY5QZO15J2Z8PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]6
carnauba waxINACTIVE INGREDIENTR12CBM0EIZPEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]6
hydroxypropyl cellulose (type L)INACTIVE INGREDIENTUKE75GEA7FPEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]6
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]6
magnesium stearateINACTIVE INGREDIENT70097M6I30PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]6
talcINACTIVE INGREDIENT7SEV7J4R1UPEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16837-855PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [KENVUE BRANDS LLC]23Current NDC, Legacy NDC, 50 package rows20241114_2854047f-c5c4-43c3-8ef2-5c0a84a307f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN2854047f-c5c4-43c3-8ef2-5c0a84a307f223
104094Pepcid AC 20 MG Oral TabletPSN2854047f-c5c4-43c3-8ef2-5c0a84a307f223
104094famotidine 20 MG Oral Tablet [Pepcid]SBD2854047f-c5c4-43c3-8ef2-5c0a84a307f223
310273famotidine 20 MG Oral TabletSCD2854047f-c5c4-43c3-8ef2-5c0a84a307f223
104094Pepcid 20 MG Oral TabletSY2854047f-c5c4-43c3-8ef2-5c0a84a307f223
104094Pepcid AC 20 MG Oral TabletSY2854047f-c5c4-43c3-8ef2-5c0a84a307f223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16837-855-02168370855022 POUCH in 1 CARTON (16837-855-02) / 1 TABLET, FILM COATED in 1 POUCH2 pouch2023-06-05NoNoHistorical
16837-855-05168370855051 BLISTER PACK in 1 CARTON (16837-855-05) > 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2003-09-010000-00-00NoNoCurrent
16837-855-09168370855091 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-12168370855121 BOTTLE, PLASTIC in 1 CARTON (16837-855-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-13168370855131 TABLET, FILM COATED in 1 POUCH (16837-855-13) 2003-09-010000-00-00NoNoCurrent
16837-855-14168370855145 BLISTER PACK in 1 CARTON (16837-855-14) / 5 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2003-09-010000-00-00NoNoCurrent
16837-855-15168370855151 BOTTLE, PLASTIC in 1 CARTON (16837-855-15) / 35 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-16168370855161 BOTTLE, PLASTIC in 1 CARTON (16837-855-16) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-17168370855171 BOTTLE, PLASTIC in 1 CARTON (16837-855-17) > 65 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-18168370855181 BOTTLE, PLASTIC in 1 CARTON (16837-855-18) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-19168370855191 BLISTER PACK in 1 CARTON (16837-855-19) / 8 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2015-04-270000-00-00NoNoCurrent
16837-855-20168370855202 CARTON in 1 PACKAGE (16837-855-20) / 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2 carton2014-08-220000-00-00NoNoCurrent
16837-855-24168370855242500 POUCH in 1 CARTON (16837-855-24) / 1 TABLET, FILM COATED in 1 POUCH2500 pouch2023-06-05NoNoHistorical
16837-855-25168370855255 in 1 BLISTER PACKHistorical
16837-855-40168370855405 BLISTER PACK in 1 CARTON (16837-855-40) > 8 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2003-09-010000-00-00NoNoCurrent
16837-855-49168370855491 BOTTLE, PLASTIC in 1 CARTON (16837-855-49) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-50168370855501 BOTTLE, PLASTIC in 1 CARTON (16837-855-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-511683708555112 BLISTER PACK in 1 CARTON (16837-855-51) > 5 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2003-09-010000-00-00NoNoCurrent
16837-855-521683708555250 POUCH in 1 TRAY (16837-855-52) / 1 TABLET, FILM COATED in 1 POUCH50 pouch2003-09-010000-00-00NoNoCurrent
16837-855-65168370855651 BOTTLE, PLASTIC in 1 CARTON (16837-855-65) > 65 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-67168370855671 BOTTLE, PLASTIC in 1 CARTON (16837-855-67) > 65 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-70168370855701 BOTTLE, PLASTIC in 1 CARTON (16837-855-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-75168370855751 BOTTLE, PLASTIC in 1 CARTON (16837-855-75) / 75 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-010000-00-00NoNoCurrent
16837-855-80168370855801 BOTTLE, PLASTIC in 1 CARTON (16837-855-80) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-01NoNoHistorical
16837-855-85168370855851 BOTTLE, PLASTIC in 1 CARTON (16837-855-85) / 85 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2003-09-01NoNoHistorical
16837-855-9016837085590125 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (16837-855-90) 2021-03-15NoNoHistorical