FDA.reportPublic FDA data

Zantac 360 Cool Mint

Product NDC
41167-0364
11-digit product format
411670364
Labeler code
41167
Product ID
41167-0364_a185b361-cf81-4912-8020-d8f778903597
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
ANDA206531
Marketing category
ANDA
Marketing start
2022-12-01
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
Zantac 360 Cool Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui310273, 2609246

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
41167-0364-0Zantac 360 Cool Mint25 in 1 BOTTLETABLET, FILM COATED254
41167-0364-0Zantac 360 Cool Mint1 in 1 CARTONTABLET, FILM COATED14
41167-0364-1Zantac 360 Cool Mint50 in 1 BOTTLETABLET, FILM COATED504
41167-0364-1Zantac 360 Cool Mint1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0364ZANTAC 360 COOL MINT (FAMOTIDINE) TABLET, FILM COATED [CHATTEM, INC.]2Current NDC, Legacy NDC, 4 package rows20230225_19fe7c6e-243c-4005-a63a-f8cac1ce55c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN19fe7c6e-243c-4005-a63a-f8cac1ce55c84
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022PSN19fe7c6e-243c-4005-a63a-f8cac1ce55c84
2609246famotidine 20 MG Oral Tablet [Zantac Reformulated Aug 2022]SBD19fe7c6e-243c-4005-a63a-f8cac1ce55c84
310273famotidine 20 MG Oral TabletSCD19fe7c6e-243c-4005-a63a-f8cac1ce55c84
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022SY19fe7c6e-243c-4005-a63a-f8cac1ce55c84
2609246Zantac Reformulated Aug 2022 20 MG Oral TabletSY19fe7c6e-243c-4005-a63a-f8cac1ce55c84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0364-0411670364001 BOTTLE in 1 CARTON (41167-0364-0) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-12-01NoNoCurrent
41167-0364-1411670364011 BOTTLE in 1 CARTON (41167-0364-1) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-12-010000-00-00NoNoCurrent