Methimazole

Product NDC
62135-205
11-digit product format
621350205
Labeler code
62135
Product ID
62135-205_4cb57dfc-1ebf-8510-e063-6294a90a31fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA040411
Marketing category
ANDA
Marketing start
2001-03-27
Substance
METHIMAZOLE
Active strength
5 mg/1
Pharmacologic classes
Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methimazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHIMAZOLE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii554Z48XN5E
Rxcui197941, 197942

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42f09d00-d445-e29e-bea8-dfb46b9366fcProduct name420251118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-205-01Methimazole100 in 1 BOTTLETABLET1004
62135-205-05Methimazole500 in 1 BOTTLETABLET5004
62135-205-18Methimazole180 in 1 BOTTLETABLET1804
62135-205-30Methimazole30 in 1 BOTTLETABLET304
62135-205-90Methimazole90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-205-18EA - Each62135-205a5db2eeb-f389-4055-91cb-e524e9af2cfb12021-11-09
62135-205-90EA - Each62135-2051ea0340a-839e-4282-93f5-5cf275c98c8812021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-205METHIMAZOLE TABLET [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 5 package rows20221213_5b25e346-11b6-44ed-89f9-ab927232ac19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSN5b25e346-11b6-44ed-89f9-ab927232ac194
197942methIMAzole 5 MG Oral TabletPSN5b25e346-11b6-44ed-89f9-ab927232ac194
197941methimazole 10 MG Oral TabletSCD5b25e346-11b6-44ed-89f9-ab927232ac194
197942methimazole 5 MG Oral TabletSCD5b25e346-11b6-44ed-89f9-ab927232ac194
197941thiamazole 10 MG Oral TabletSY5b25e346-11b6-44ed-89f9-ab927232ac194
197942thiamazole 5 MG Oral TabletSY5b25e346-11b6-44ed-89f9-ab927232ac194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-205-0162135020501100 TABLET in 1 BOTTLE (62135-205-01) 100 tablet2021-11-040000-00-00NoNoCurrent
62135-205-0562135020505500 TABLET in 1 BOTTLE (62135-205-05) 500 tablet2021-11-040000-00-00NoNoCurrent
62135-205-1862135020518180 TABLET in 1 BOTTLE (62135-205-18) 180 tablet2021-11-040000-00-00NoNoCurrent
62135-205-306213502053030 TABLET in 1 BOTTLE (62135-205-30) 30 tablet2021-11-040000-00-00NoNoCurrent
62135-205-906213502059090 TABLET in 1 BOTTLE (62135-205-90) 90 tablet2021-11-040000-00-00NoNoCurrent