Methimazole

Product NDC
68071-5197
11-digit product format
680715197
Labeler code
68071
Product ID
68071-5197_d7732452-c96b-1a18-e053-2995a90a84a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methimazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040734
Marketing category
ANDA
Marketing start
2012-01-15
Marketing end
0000-00-00
Substance
METHIMAZOLE
Active strength
10 mg/1
Pharmacologic classes
Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5197-12022-02-07C16284748780-1d6a99b39-8760-a426-e053-dadaa90af4c2a083648d-21a8-0977-e053-2a95a90a9928
68071-5197-12022-01-28C16284748780-1d6a99b39-8760-a426-e053-dadaa90af4c2a083648d-21a8-0977-e053-2a95a90a9928

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5197-168071519701100 TABLET in 1 BOTTLE (68071-5197-1) 100 tablet2020-03-100000-00-00NoNoCurrent