Pepcid Complete

Product NDC
52904-948
11-digit product format
529040948
Labeler code
52904
Product ID
52904-948_fba25037-8f64-4e0d-b2bd-cc1f307c01c6
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine, Calcium Carbonate, and Magnesium Hydroxide
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Select Corporation
Application
NDA020958
Marketing category
NDA
Marketing start
2009-01-01
Marketing end
0000-00-00
Substance
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Active strength
800 mg/1; mg/1; mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-948-03Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE11
52904-948-03Pepcid Complete1 in 1 BLISTER PACKTABLET, CHEWABLE11
52904-948-07Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE11
52904-948-07Pepcid Complete2 in 1 BLISTER PACKTABLET, CHEWABLE21
52904-948-20Pepcid Complete20 in 1 CARTONTABLET, CHEWABLE201
52904-948-20Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE11
52904-948-25Pepcid Complete25 in 1 CARTONTABLET, CHEWABLE251
52904-948-25Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-948PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SELECT CORPORATION]1Legacy NDC, 8 package rows20220423_7f1903e6-e014-4a6e-86e1-38339f893ede.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSN7f1903e6-e014-4a6e-86e1-38339f893ede1
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSN7f1903e6-e014-4a6e-86e1-38339f893ede1
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBD7f1903e6-e014-4a6e-86e1-38339f893ede1
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCD7f1903e6-e014-4a6e-86e1-38339f893ede1
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSY7f1903e6-e014-4a6e-86e1-38339f893ede1
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSY7f1903e6-e014-4a6e-86e1-38339f893ede1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52904-948-03529040948031 POUCH in 1 BLISTER PACK (52904-948-03) > 1 TABLET, CHEWABLE in 1 POUCH1 pouch2009-01-010000-00-00NoNoCurrent
52904-948-07529040948072 POUCH in 1 BLISTER PACK (52904-948-07) > 1 TABLET, CHEWABLE in 1 POUCH2 pouch2009-01-010000-00-00NoNoCurrent
52904-948-205290409482020 POUCH in 1 CARTON (52904-948-20) > 1 TABLET, CHEWABLE in 1 POUCH20 pouch2009-01-010000-00-00NoNoCurrent
52904-948-255290409482525 POUCH in 1 CARTON (52904-948-25) > 1 TABLET, CHEWABLE in 1 POUCH25 pouch2009-01-010000-00-00NoNoCurrent