FDA.reportPublic FDA data

Zantac 360

Product NDC
41167-0360
11-digit product format
411670360
Labeler code
41167
Product ID
41167-0360_11934068-b70b-4afe-aff8-82f2a79068b9
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
ANDA206531
Marketing category
ANDA
Marketing start
2021-04-12
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
10 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
41167-0360-2Zantac 36030 in 1 BOTTLETABLET, FILM COATED306
41167-0360-2Zantac 3601 in 1 CARTONTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0360-2EA - Each41167-036094174742-5173-45e9-8881-bdd5b44d6fce12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0360ZANTAC 360 (FAMOTIDINE) TABLET, FILM COATED [CHATTEM, INC.]6Legacy NDC, 2 package rows20250508_89f60eb1-359b-40e8-ae8b-65aec9cd5b1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
310273famotidine 20 MG Oral TabletPSN89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2607015Zantac 360 10 MG Oral Tablet, Reformulated Aug 2022PSN89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022PSN89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2607015famotidine 10 MG Oral Tablet [Zantac Reformulated Aug 2022]SBD89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2609246famotidine 20 MG Oral Tablet [Zantac Reformulated Aug 2022]SBD89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
199047famotidine 10 MG Oral TabletSCD89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
310273famotidine 20 MG Oral TabletSCD89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2607015Zantac 360 10 MG Oral Tablet, Reformulated Aug 2022SY89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022SY89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2607015Zantac Reformulated Aug 2022 10 MG Oral TabletSY89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6
2609246Zantac Reformulated Aug 2022 20 MG Oral TabletSY89f60eb1-359b-40e8-ae8b-65aec9cd5b1f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0360-2411670360021 BOTTLE in 1 CARTON (41167-0360-2) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-04-120000-00-00NoNoCurrent