FDA.reportPublic FDA data

Maximum Strength Acid Reducer

Product NDC
11673-697
11-digit product format
116730697
Labeler code
11673
Product ID
11673-697_18567eaf-6b97-8c6f-e063-6294a90a986d
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
TARGET CORPORATION
Application
ANDA217543
Marketing category
ANDA
Marketing start
2024-05-15
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
Maximum Strength Acid Reducer
Listing expiration
2026-12-31

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
11673-697-01Maximum Strength Acid Reducer2 in 1 CARTONTABLET22
11673-697-01Maximum Strength Acid Reducer50 in 1 BOTTLETABLET502
11673-697-05Maximum Strength Acid Reducer1 in 1 CARTONTABLET12
11673-697-05Maximum Strength Acid Reducer50 in 1 BOTTLETABLET502
11673-697-20Maximum Strength Acid Reducer1 in 1 CARTONTABLET12
11673-697-20Maximum Strength Acid Reducer200 in 1 BOTTLETABLET2002
11673-697-52Maximum Strength Acid Reducer5 in 1 BLISTER PACKTABLET52
11673-697-52Maximum Strength Acid Reducer5 in 1 CARTONTABLET52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-697MAXIMUM STRENGTH ACID REDUCER (FAMOTIDINE) TABLET [TARGET CORPORATION]2Current NDC, 8 package rows20240522_07a924f1-14cc-4e7d-e063-6394a90ac7f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN07a924f1-14cc-4e7d-e063-6394a90ac7f32
310273famotidine 20 MG Oral TabletSCD07a924f1-14cc-4e7d-e063-6394a90ac7f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-697-01116730697012 BOTTLE in 1 CARTON (11673-697-01) / 50 TABLET in 1 BOTTLE2 bottle2024-05-15NoNoCurrent
11673-697-05116730697051 BOTTLE in 1 CARTON (11673-697-05) / 50 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
11673-697-20116730697201 BOTTLE in 1 CARTON (11673-697-20) / 200 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
11673-697-52116730697525 BLISTER PACK in 1 CARTON (11673-697-52) / 5 TABLET in 1 BLISTER PACK5 blister pack2024-05-15NoNoCurrent