Glimepiride

Product NDC: 66116-432
11-digit product format: 661160432
Labeler code: 66116
Product ID: 66116-432_3f626e54-b043-4556-9568-ace556cff9e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: MedVantx, Inc.
Application: ANDA076802
Marketing category: ANDA
Marketing start: 2012-04-19
Marketing end: 0000-00-00
Substance: GLIMEPIRIDE
Active strength: 2 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66116-432		I	Inactivated by FDA		2026-07-31
excluded package	package	66116-432	66116-432-30	I	Inactivated by FDA		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076802-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06
A076802-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06
A076802-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b890b964-2cf0-4439-aaf3-900c9e3e9e49	Product name	1	20160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8	Product name	1	20140508
d36d861f-8a90-80cc-8935-1e6be9b4c7eb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66116-432-30	2019-11-13	C162847	48780-1	97449f38-bce7-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use glimepiride tablets USP safely and effectively. See full prescribing information for glimepiride tablets USP. GLIMEPIRIDE tablets USP for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66116-432-30	Glimepiride	30 in 1 BOTTLE	TABLET	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66116-432	GLIMEPIRIDE TABLET [MEDVANTX, INC.]	1	Legacy NDC, 1 package rows	20120710_3f626e54-b043-4556-9568-ace556cff9e9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6KY687524K	GLIMEPIRIDE	93479-97-1	GLIMEPIRIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199246	glimepiride 2 MG Oral Tablet	PSN	3f626e54-b043-4556-9568-ace556cff9e9	1
199246	glimepiride 2 MG Oral Tablet	SCD	3f626e54-b043-4556-9568-ace556cff9e9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66116-432-30	66116043230	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glimepiride	MedVantx, Inc. \| Teva Pharmaceuticals USA Inc \| Blenheim Pharmacal, Inc.	2012-04-19	HUMAN PRESCRIPTION DRUG LABEL	1