FDA.reportPublic FDA data

Leader Extra Strength Antacid

Product NDC
70000-0430
11-digit product format
700000430
Labeler code
70000
Product ID
70000-0430_e08928a7-193e-4fe8-90c9-249d4353c3c4
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-10
Marketing end
2026-12-31
Substance
CALCIUM CARBONATE
Active strength
750 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Extra Strength Antacid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK
Rxcui308915

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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0430-2Leader Extra Strength Antacid96 in 1 BOTTLETABLET, CHEWABLE966

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0430-2EA - Each70000-0430bc303b1b-a4c4-46f6-b1f4-b32d6414edf812020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0430LEADER EXTRA STRENGTH ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, Legacy NDC, 1 package rows20241207_c7a8c877-3e20-4910-8ea4-1714fac3ff2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSNc7a8c877-3e20-4910-8ea4-1714fac3ff2f6
308915calcium carbonate 750 MG Chewable TabletSCDc7a8c877-3e20-4910-8ea4-1714fac3ff2f6
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSYc7a8c877-3e20-4910-8ea4-1714fac3ff2f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0430-27000004300296 TABLET, CHEWABLE in 1 BOTTLE (70000-0430-2) 2019-07-102026-12-31NoNoCurrent