FDA.reportPublic FDA data

Pepcid AC

Product NDC
66715-9748
11-digit product format
667159748
Labeler code
66715
Product ID
66715-9748_0e8487fc-3e0e-bbfc-e063-6394a90a3073
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
NDA020325
Marketing category
NDA
Marketing start
2020-04-01
Substance
FAMOTIDINE
Active strength
20 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 AC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui104094, 310273

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-9748-8Pepcid AC1 in 1 BLISTER PACKTABLET, FILM COATED17
66715-9748-8Pepcid AC5 in 1 CARTONTABLET, FILM COATED57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9748PEPCID AC (FAMOTIDINE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]7Current NDC, Legacy NDC, 2 package rows20240110_14406cd8-468b-403d-9be2-43decd304214.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN14406cd8-468b-403d-9be2-43decd3042147
104094Pepcid AC 20 MG Oral TabletPSN14406cd8-468b-403d-9be2-43decd3042147
104094famotidine 20 MG Oral Tablet [Pepcid]SBD14406cd8-468b-403d-9be2-43decd3042147
310273famotidine 20 MG Oral TabletSCD14406cd8-468b-403d-9be2-43decd3042147
104094Pepcid 20 MG Oral TabletSY14406cd8-468b-403d-9be2-43decd3042147
104094Pepcid AC 20 MG Oral TabletSY14406cd8-468b-403d-9be2-43decd3042147

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9748-8667159748085 BLISTER PACK in 1 CARTON (66715-9748-8) / 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2020-04-012023-11-18NoNoCurrent