FDA.reportPublic FDA data

Pepcid Complete

Product NDC
70264-034
11-digit product format
702640034
Labeler code
70264
Product ID
70264-034_43c8f02d-6724-ad9f-e063-6294a90a0702
Type
HUMAN OTC DRUG
Nonproprietary name
famotidine, calcium carbonate, and magnesium hydroxide
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
R J General Corporation
Application
NDA020958
Marketing category
NDA
Marketing start
2022-01-09
Substance
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Active strength
800; 10; 165 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pepcid Complete
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE800 mg/1
FAMOTIDINE10 mg/1
MAGNESIUM HYDROXIDE165 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK, 5QZO15J2Z8, NBZ3QY004S
Rxcui283641, 688892

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
70264-034-01Pepcid Complete50 in 1 CARTONTABLET, CHEWABLE504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70264-034PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [R J GENERAL CORPORATION]3Current NDC, Legacy NDC, 1 package rows20241030_f0e08608-e9b0-3203-e053-2995a90adfbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSNf0e08608-e9b0-3203-e053-2995a90adfbd4
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSNf0e08608-e9b0-3203-e053-2995a90adfbd4
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBDf0e08608-e9b0-3203-e053-2995a90adfbd4
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCDf0e08608-e9b0-3203-e053-2995a90adfbd4
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSYf0e08608-e9b0-3203-e053-2995a90adfbd4
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSYf0e08608-e9b0-3203-e053-2995a90adfbd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70264-034-017026400340150 TABLET, CHEWABLE in 1 CARTON (70264-034-01) 2022-12-280000-00-00NoNoCurrent