HELIDAC Therapy

Product NDC
70199-021
11-digit product format
701990021
Labeler code
70199
Product ID
70199-021_ea33e2ed-b75c-457e-bbf0-0604c59d302b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules
Dosage form
KIT
Labeler
Casper Pharma LLC
Application
ANDA202584
Marketing category
ANDA
Marketing start
2020-06-11
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70199-021-142025-08-05C16284748780-1d6a99b39-f55a-a426-e053-dadaa90af4c2eb651905-007d-4a56-b010-db4a4f7c405d
70199-021-142022-01-28C16284748780-1d6a99b39-f55a-a426-e053-dadaa90af4c2eb651905-007d-4a56-b010-db4a4f7c405d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70199-021-14EA - Each70199-021d3f1c26d-b642-4d2d-80f1-9f964b6961c512020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70199-021HELIDAC THERAPY (BISMUTH SUBSALICYLATE CHEWABLE TABLETS/METRONIDAZOLE TABLETS/TETRACYCLINE HYDROCHLORIDE CAPSULES) KIT [CASPER PHARMA LLC]2Legacy NDC20200618_eb651905-007d-4a56-b010-db4a4f7c405d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70199-021-147019900211414 BLISTER PACK in 1 CARTON (70199-021-14) > 4 PACKAGE in 1 BLISTER PACK > 1 KIT in 1 PACKAGE14 blister pack2020-06-110000-00-00NoNoCurrent