FDA.reportPublic FDA data

Pepcid AC

Product NDC
16837-872
11-digit product format
168370872
Labeler code
16837
Product ID
16837-872_4a227807-355e-b37d-e063-6394a90a7639
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
1995-10-01
Substance
FAMOTIDINE
Active strength
10 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pepcid AC
Brand name suffix
Original Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047, 212072

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16837-872-10Pepcid ACOriginal Strength10 in 1 BLISTER PACKTABLET, FILM COATED1020
16837-872-10Pepcid ACOriginal Strength1 in 1 CARTONTABLET, FILM COATED120
16837-872-20Pepcid ACOriginal Strength3 in 1 CARTONTABLET, FILM COATED320
16837-872-20Pepcid ACOriginal Strength10 in 1 BLISTER PACKTABLET, FILM COATED1020
16837-872-22Pepcid ACOriginal Strength1 in 1 CARTONTABLET, FILM COATED120
16837-872-22Pepcid ACOriginal Strength90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020
16837-872-30Pepcid ACOriginal Strength3 in 1 CARTONTABLET, FILM COATED320
16837-872-30Pepcid ACOriginal Strength10 in 1 BLISTER PACKTABLET, FILM COATED1020
16837-872-31Pepcid ACOriginal Strength4 in 1 CARTONTABLET, FILM COATED420
16837-872-31Pepcid ACOriginal Strength10 in 1 BLISTER PACKTABLET, FILM COATED1020
16837-872-60Pepcid ACOriginal Strength1 in 1 CARTONTABLET, FILM COATED120
16837-872-60Pepcid ACOriginal Strength60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020
16837-872-75Pepcid ACOriginal Strength1 in 1 CARTONTABLET, FILM COATED120
16837-872-75Pepcid ACOriginal Strength75 in 1 BOTTLE, PLASTICTABLET, FILM COATED7520
16837-872-90Pepcid ACOriginal Strength1 in 1 CARTONTABLET, FILM COATED120
16837-872-90Pepcid ACOriginal Strength90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16837-872-20EA - Each16837-872ed3bdbd8-a9ff-41b4-97d5-1a3c830db28a12020-06-05
16837-872-22EA - Each16837-872e277def6-18e6-4165-9944-4015a4a0dd0512021-05-05
16837-872-30EA - Each16837-87236ded51f-29fb-4eda-a14b-fa89ccec2f0412018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FamotidineACTIVE INGREDIENT5QZO15J2Z8PEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
FamotidineACTIVE MOIETY5QZO15J2Z8PEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
carnauba waxINACTIVE INGREDIENTR12CBM0EIZPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
ferric oxide redINACTIVE INGREDIENT1K09F3G675PEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30PEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
talcINACTIVE INGREDIENT7SEV7J4R1UPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16837-872PEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [KENVUE BRANDS LLC]19Current NDC, Legacy NDC, 16 package rows20241114_54f4086f-e443-4e7e-8c7e-94e152e1c256.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN54f4086f-e443-4e7e-8c7e-94e152e1c25620
212072Pepcid AC 10 MG Oral TabletPSN54f4086f-e443-4e7e-8c7e-94e152e1c25620
212072famotidine 10 MG Oral Tablet [Pepcid]SBD54f4086f-e443-4e7e-8c7e-94e152e1c25620
199047famotidine 10 MG Oral TabletSCD54f4086f-e443-4e7e-8c7e-94e152e1c25620
212072Pepcid 10 MG Oral TabletSY54f4086f-e443-4e7e-8c7e-94e152e1c25620
212072Pepcid AC Original 10 MG Oral TabletSY54f4086f-e443-4e7e-8c7e-94e152e1c25620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16837-872-10168370872101 BLISTER PACK in 1 CARTON (16837-872-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2011-01-210000-00-00NoNoCurrent
16837-872-20168370872203 BLISTER PACK in 1 CARTON (16837-872-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2011-01-210000-00-00NoNoCurrent
16837-872-22168370872221 BOTTLE, PLASTIC in 1 CARTON (16837-872-22) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2011-01-210000-00-00NoNoCurrent
16837-872-30168370872303 BLISTER PACK in 1 CARTON (16837-872-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack1995-10-010000-00-00NoNoCurrent
16837-872-31168370872314 BLISTER PACK in 1 CARTON (16837-872-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1995-10-010000-00-00NoNoCurrent
16837-872-60168370872601 BOTTLE, PLASTIC in 1 CARTON (16837-872-60) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1995-10-010000-00-00NoNoCurrent
16837-872-75168370872751 BOTTLE, PLASTIC in 1 CARTON (16837-872-75) > 75 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2021-03-150000-00-00NoNoCurrent
16837-872-90168370872901 BOTTLE, PLASTIC in 1 CARTON (16837-872-90) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1995-10-010000-00-00NoNoCurrent