acid reducer

Product NDC
59640-023
11-digit product format
596400023
Labeler code
59640
Product ID
59640-023_b8b7bb2e-3c48-4aba-a4cb-b33b70383fd0
Type
HUMAN OTC DRUG
Nonproprietary name
famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA077351
Marketing category
ANDA
Marketing start
2022-12-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acid reducer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui310273

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
59640-023-71acid reducer50 in 1 BOTTLETABLET, FILM COATED503
59640-023-71acid reducer1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59640-023ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [H E B]2Current NDC, Legacy NDC, 2 package rows20230106_140f0e60-c809-4d86-a750-7649ee2881b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN140f0e60-c809-4d86-a750-7649ee2881b53
310273famotidine 20 MG Oral TabletSCD140f0e60-c809-4d86-a750-7649ee2881b53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59640-023-71596400023711 BOTTLE in 1 CARTON (59640-023-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-12-190000-00-00NoNoCurrent