TopiDex

Product NDC
70112-555
11-digit product format
701120555
Labeler code
70112
Product ID
70112-555_69333734-6371-4310-e053-2a91aa0a611c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone surgical combo kit
Dosage form
KIT
Labeler
Topicare Management, LLC
Application
ANDA040491
Marketing category
ANDA
Marketing start
2018-04-16
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70112-555-022020-01-31C16284748780-19d75b9d0-2437-f424-e053-dadaa90a57ce69333734-6370-4310-e053-2a91aa0a611c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-121-14TopiDex0.55 mL in 1 POUCHSWAB1.65 mL0.7 mL in 1mL1
70112-555-02TopiDex1 in 1 BOXKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70112-555-02EA - Each70112-555b3088a4e-8c3a-40b9-8fd8-58a28274cc0712018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70112-555TOPIDEX (DEXAMETHASONE SURGICAL COMBO KIT) KIT [TOPICARE MANAGEMENT, LLC]1Legacy NDC, 2 package rows20180418_69333734-6370-4310-e053-2a91aa0a611c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSN69333734-6370-4310-e053-2a91aa0a611c1
797544isopropyl alcohol 70 % Medicated PadPSN69333734-6370-4310-e053-2a91aa0a611c1
797730povidone-iodine 10 % Medicated PadPSN69333734-6370-4310-e053-2a91aa0a611c1
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCD69333734-6370-4310-e053-2a91aa0a611c1
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD69333734-6370-4310-e053-2a91aa0a611c1
797730povidone-iodine 100 MG/ML Medicated PadSCD69333734-6370-4310-e053-2a91aa0a611c1
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSY69333734-6370-4310-e053-2a91aa0a611c1
797544isopropyl alcohol 70 % Medicated PadSY69333734-6370-4310-e053-2a91aa0a611c1
797544isopropyl alcohol 70 % Topical ClothSY69333734-6370-4310-e053-2a91aa0a611c1
797544isopropyl alcohol 70 % Topical SwabSY69333734-6370-4310-e053-2a91aa0a611c1
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY69333734-6370-4310-e053-2a91aa0a611c1
797730povidone-iodine 10 % Medicated PadSY69333734-6370-4310-e053-2a91aa0a611c1
797730povidone-iodine 10 % Medicated SwabstickSY69333734-6370-4310-e053-2a91aa0a611c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67777-121-14677770121140.55 mL in 1 POUCH0.55 mlHistorical
70112-555-02701120555021 in 1 BOXHistorical