FDA.reportPublic FDA data

LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE

Product NDC
13411-843
Requested package NDC
13411-843-24
11-digit product format
134110843
Labeler code
13411
Product ID
13411-843_9745e6c6-cba8-4238-b344-5821a2939fa4
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
750 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13411-84313411-843-24IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
13411-843-242022-01-28C16284748780-1d6a99b39-75e0-a426-e053-dadaa90af4c2LEGEND PREMIUM HEARTBURN RELIEF-EXTRA STRENGTH CHEWABLE
13411-843-302022-01-28C16284748780-1d6a99b39-75e0-a426-e053-dadaa90af4c2LEGEND PREMIUM HEARTBURN RELIEF-EXTRA STRENGTH CHEWABLE
13411-843-602022-01-28C16284748780-1d6a99b39-75e0-a426-e053-dadaa90af4c2LEGEND PREMIUM HEARTBURN RELIEF-EXTRA STRENGTH CHEWABLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-843-24LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE24 in 1 BOXTABLET241
13411-843-30LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE30 in 1 BOXTABLET301
13411-843-60LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE60 in 1 BOXTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-843LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE (CALCIUM CARBONATE) TABLET [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 3 package rows20200630_8601a194-fdf1-4a33-854e-153a7a2c578e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN8601a194-fdf1-4a33-854e-153a7a2c578e1
308915calcium carbonate 750 MG Chewable TabletSCD8601a194-fdf1-4a33-854e-153a7a2c578e1
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY8601a194-fdf1-4a33-854e-153a7a2c578e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13411-843-241341108432424 TABLET in 1 BOX (13411-843-24) 24 tablet2020-06-220000-00-00NoNoCurrent