FDA.reportPublic FDA data

Pepcid Complete

Product NDC
50269-016
11-digit product format
502690016
Labeler code
50269
Product ID
50269-016_2a950ee0-8ed6-565d-e063-6294a90a3086
Type
HUMAN OTC DRUG
Nonproprietary name
FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
JC World Bell Wholesale Co., Inc.
Application
NDA020958
Marketing category
NDA
Marketing start
2020-09-01
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
50269-016-01Pepcid Complete1 in 1 BLISTER PACKTABLET, CHEWABLE14
50269-016-01Pepcid Complete6 in 1 BOXTABLET, CHEWABLE64
50269-016-02Pepcid Complete6 in 1 BOXTABLET, CHEWABLE64
50269-016-02Pepcid Complete2 in 1 BLISTER PACKTABLET, CHEWABLE24
50269-016-25Pepcid Complete1 in 1 POUCHTABLET, CHEWABLE14
50269-016-25Pepcid Complete25 in 1 BOXTABLET, CHEWABLE254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50269-016PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JC WORLD BELL WHOLESALE CO., INC.]4Current NDC, Legacy NDC, 6 package rows20250101_39f7ee67-4eab-42b0-82fc-40dc8ce7666b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSN39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
688892Pepcid Complete Dual Action 10 MG / 800 MG (Ca 320 MG) / 165 MG Chewable TabletPSN39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
688892calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet [Pepcid Complete]SBD39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCD39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSY39f7ee67-4eab-42b0-82fc-40dc8ce7666b4
688892Pepcid Complete (calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG) Chewable TabletSY39f7ee67-4eab-42b0-82fc-40dc8ce7666b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50269-016-01502690016016 BLISTER PACK in 1 BOX (50269-016-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2020-09-010000-00-00NoNoCurrent
50269-016-02502690016026 BLISTER PACK in 1 BOX (50269-016-02) / 2 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2020-09-010000-00-00NoNoCurrent
50269-016-255026900162525 POUCH in 1 BOX (50269-016-25) / 1 TABLET, CHEWABLE in 1 POUCH25 pouch2020-09-010000-00-00NoNoCurrent