FDA.reportPublic FDA data

LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF

Product NDC
13411-845
11-digit product format
134110845
Labeler code
13411
Product ID
13411-845_8d05f0e3-af49-40c6-998f-1064fc99efc2
Type
HUMAN OTC DRUG
Nonproprietary name
CALCIUM CARBONATE
Dosage form
TABLET
Route
ORAL
Labeler
ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-06-22
Marketing end
0000-00-00
Substance
CALCIUM CARBONATE
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-845-242022-01-28C16284748780-1d6a99b39-5be3-a426-e053-dadaa90af4c2LEGEND PREMIUM HEARTBURN RELIEF CHEWABLE
13411-845-302022-01-28C16284748780-1d6a99b39-5be3-a426-e053-dadaa90af4c2LEGEND PREMIUM HEARTBURN RELIEF CHEWABLE
13411-845-602022-01-28C16284748780-1d6a99b39-5be3-a426-e053-dadaa90af4c2LEGEND PREMIUM HEARTBURN RELIEF CHEWABLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-845-24LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF24 in 1 BOXTABLET241
13411-845-30LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF30 in 1 BOXTABLET301
13411-845-60LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF60 in 1 BOXTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-845LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF (CALCIUM CARBONATE) TABLET [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 3 package rows20200630_a6184338-cd4a-42a3-8eb4-a91f16e37c7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSNa6184338-cd4a-42a3-8eb4-a91f16e37c7b1
308907calcium carbonate 500 MG Chewable TabletSCDa6184338-cd4a-42a3-8eb4-a91f16e37c7b1
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSYa6184338-cd4a-42a3-8eb4-a91f16e37c7b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13411-845-241341108452424 TABLET in 1 BOX (13411-845-24) 24 tablet2020-06-220000-00-00NoNoCurrent
13411-845-301341108453030 TABLET in 1 BOX (13411-845-30) 30 tablet2020-06-220000-00-00NoNoCurrent
13411-845-601341108456060 TABLET in 1 BOX (13411-845-60) 60 tablet2020-06-220000-00-00NoNoCurrent