FDA.reportPublic FDA data

Rugby Calcium Carbonate 10 gr

Product NDC
43353-958
Requested package NDC
43353-958-92
11-digit product format
433530958
Labeler code
43353
Product ID
43353-958_451f0be0-8e23-4426-a62f-73540f6f2d73
Type
HUMAN OTC DRUG
Nonproprietary name
Antacid Tablets
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-07
Marketing end
0000-00-00
Substance
CALCIUM CARBONATE
Active strength
648 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage43353-95843353-958-92DDiscontinued by firm2026-10-15

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-95843353-958-92DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-95843353-958-92DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-958-30EA - Each43353-958c806bf96-6c59-4731-ac9b-2e21435aa71712016-07-19
43353-958-53EA - Each43353-95819dd3a3b-9fe2-47d6-998e-1ff04fa1011212016-07-19
43353-958-60EA - Each43353-95853c00a91-b221-4812-ae07-2a49342561ef12016-07-19
43353-958-65EA - Each43353-9584b2477a6-7a1d-44af-9638-cc6dc607e67012016-07-19
43353-958-80EA - Each43353-9584918107e-68f4-442e-bf0e-8acfabecb13e12016-07-19
43353-958-85EA - Each43353-9589d33682f-575c-4519-aeb8-f9af1bc9a99612016-07-19
43353-958-92EA - Each43353-958c4ce2d9d-80b3-4bc8-b62f-73be288755c012016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-958RUGBY CALCIUM CARBONATE 10 GR (ANTACID TABLETS) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20160711_1a92abe8-8310-4ac2-92fe-27dd72ccce50.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-958-9243353095892270 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43353-958-92) 2014-08-010000-00-00NoNoCurrent