METHIMAZOLE

Product NDC: 68788-0681
11-digit product format: 687880681
Labeler code: 68788
Product ID: 68788-0681_2f5d3988-e004-4c55-9659-4ba724a43d5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHIMAZOLE
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA202068
Marketing category: ANDA
Marketing start: 2014-02-27
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: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
42f09d00-d445-e29e-bea8-dfb46b9366fc	Product name	4	20251118

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68788-0681-1	2020-01-31	C162847	48780-1	9d75b9d0-1912-f424-e053-dadaa90a57ce	METHIMAZOLE Tablets, USP Rx Only
68788-0681-2	2020-01-31	C162847	48780-1	9d75b9d0-1912-f424-e053-dadaa90a57ce	METHIMAZOLE Tablets, USP Rx Only
68788-0681-3	2020-01-31	C162847	48780-1	9d75b9d0-1912-f424-e053-dadaa90a57ce	METHIMAZOLE Tablets, USP Rx Only
68788-0681-6	2020-01-31	C162847	48780-1	9d75b9d0-1912-f424-e053-dadaa90a57ce	METHIMAZOLE Tablets, USP Rx Only
68788-0681-9	2020-01-31	C162847	48780-1	9d75b9d0-1912-f424-e053-dadaa90a57ce	METHIMAZOLE Tablets, USP Rx Only

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-0681-1	METHIMAZOLE	100 in 1 BOTTLE	TABLET	100	3
68788-0681-2	METHIMAZOLE	20 in 1 BOTTLE	TABLET	20	3
68788-0681-3	METHIMAZOLE	30 in 1 BOTTLE	TABLET	30	3
68788-0681-6	METHIMAZOLE	60 in 1 BOTTLE	TABLET	60	3
68788-0681-9	METHIMAZOLE	90 in 1 BOTTLE	TABLET	90	3

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHIMAZOLE	ACTIVE INGREDIENT	554Z48XN5E	METHIMAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
METHIMAZOLE	ACTIVE MOIETY	554Z48XN5E	METHIMAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METHIMAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHIMAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHIMAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-0681	METHIMAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3	Legacy NDC, 5 package rows	20161216_665bf04b-9732-4e24-944b-6599ba2730de.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
554Z48XN5E	METHIMAZOLE	60-56-0	METHIMAZOLE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197941	methIMAzole 10 MG Oral Tablet	PSN	665bf04b-9732-4e24-944b-6599ba2730de	3
197941	methimazole 10 MG Oral Tablet	SCD	665bf04b-9732-4e24-944b-6599ba2730de	3
197941	thiamazole 10 MG Oral Tablet	SY	665bf04b-9732-4e24-944b-6599ba2730de	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68788-0681-1	68788068101	100 in 1 BOTTLE	Historical
68788-0681-2	68788068102	20 in 1 BOTTLE	Historical
68788-0681-3	68788068103	30 in 1 BOTTLE	Historical
68788-0681-6	68788068106	60 in 1 BOTTLE	Historical
68788-0681-9	68788068109	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METHIMAZOLE Tablets, USP Rx Only	Preferred Pharmaceuticals, Inc.	2016-12-16	HUMAN PRESCRIPTION DRUG LABEL	3