FDA.reportPublic FDA data

Pepcid Complete

Product NDC
67751-202
11-digit product format
677510202
Labeler code
67751
Product ID
67751-202_1626fa89-cec4-6467-e063-6294a90aa2a4
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine, Calcium carbonate, and Magnesium hydroxide
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Navajo Manufacturing Company Inc
Application
NDA020958
Marketing category
NDA
Marketing start
2020-08-06
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-202-012024-04-15C16284748780-11030e364-ff64-111a-e063-dadaa90a10e2Pepcid Complete
67751-202-022024-04-15C16284748780-11030e364-ff64-111a-e063-dadaa90a10e2Pepcid Complete
67751-202-012024-01-30C16284748780-11030e364-ff64-111a-e063-dadaa90a10e2Pepcid Complete
67751-202-022024-01-30C16284748780-11030e364-ff64-111a-e063-dadaa90a10e2Pepcid Complete

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-202-01Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE12
67751-202-01Pepcid Complete1 in 1 CARTONTABLET, CHEWABLE12
67751-202-02Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE12
67751-202-02Pepcid Complete2 in 1 CARTONTABLET, CHEWABLE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-202PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [NAVAJO MANUFACTURING COMPANY INC]2Current NDC, Legacy NDC, 4 package rows20240417_ac3cd760-4615-117b-e053-2a95a90a8d42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSNac3cd760-4615-117b-e053-2a95a90a8d422
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSNac3cd760-4615-117b-e053-2a95a90a8d422
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBDac3cd760-4615-117b-e053-2a95a90a8d422
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCDac3cd760-4615-117b-e053-2a95a90a8d422
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSYac3cd760-4615-117b-e053-2a95a90a8d422
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSYac3cd760-4615-117b-e053-2a95a90a8d422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-202-01677510202011 POUCH in 1 CARTON (67751-202-01) / 1 TABLET, CHEWABLE in 1 POUCH1 pouch2020-08-060000-00-00NoNoCurrent
67751-202-02677510202022 POUCH in 1 CARTON (67751-202-02) / 1 TABLET, CHEWABLE in 1 POUCH2 pouch2020-08-060000-00-00NoNoCurrent