GLYBURIDE

Product NDC: 23155-058
11-digit product format: 231550058
Labeler code: 23155
Product ID: 23155-058_98ed9f46-1633-4f82-bd51-ff87b0157871
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GLYBURIDE
Dosage form: TABLET
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA090937
Marketing category: ANDA
Marketing start: 2010-10-05
Substance: GLYBURIDE
Active strength: 5 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: GLYBURIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYBURIDE	5 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	SX6K58TVWC
Rxcui	197737, 310534, 310537

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6	Product name	2	20160609
5a2baaae-1290-c05e-207f-b1367e9eb46a	Product name	2	20151005
b044018d-bcdc-e68d-63da-1ad6886aea64	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
23155-058-01	GLYBURIDE	100 in 1 BOTTLE	TABLET	100		12
23155-058-10	GLYBURIDE	1000 in 1 BOTTLE	TABLET	1000		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-058-01	EA - Each	23155-058	3f130585-9a51-46d9-af15-3e46cf048254	1	2012-07-24
23155-058-10	EA - Each	23155-058	b47a6afe-ec6b-4b77-885e-9f3c551fbc31	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [TYA PHARMACEUTICALS]	2
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [TYA PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE TABLET [TYA PHARMACEUTICALS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLYBURIDE TABLET [TYA PHARMACEUTICALS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLYBURIDE TABLET [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [TYA PHARMACEUTICALS]	2
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP]	1
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLYBURIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GLYBURIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLYBURIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23155-058	GLYBURIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]	11	Current NDC, Legacy NDC, 2 package rows	20241215_33418bba-c5ea-4c0f-9d28-31dc2724c6c3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SX6K58TVWC	GLYBURIDE	10238-21-8	GLYBURIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310537	glyBURIDE 5 MG Oral Tablet	PSN	05341afe-5b7a-462a-a196-689cb09f83fc	103
310537	glyburide 5 MG Oral Tablet	SCD	05341afe-5b7a-462a-a196-689cb09f83fc	103
310537	glibenclamide 5 MG Oral Tablet	SY	05341afe-5b7a-462a-a196-689cb09f83fc	103
197737	glyBURIDE 1.25 MG Oral Tablet	PSN	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	12
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	12
310537	glyBURIDE 5 MG Oral Tablet	PSN	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	12
197737	glyburide 1.25 MG Oral Tablet	SCD	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	12
310534	glyburide 2.5 MG Oral Tablet	SCD	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	12
310537	glyburide 5 MG Oral Tablet	SCD	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	12
197737	glibenclamide 1.25 MG Oral Tablet	SY	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	12
310534	glibenclamide 2.5 MG Oral Tablet	SY	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	12
310537	glibenclamide 5 MG Oral Tablet	SY	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	12
310537	glyBURIDE 5 MG Oral Tablet	PSN	3c91a408-973b-4572-832f-515f61d5be1f	11
310537	glyburide 5 MG Oral Tablet	SCD	3c91a408-973b-4572-832f-515f61d5be1f	11
310537	glibenclamide 5 MG Oral Tablet	SY	3c91a408-973b-4572-832f-515f61d5be1f	11
310537	glyBURIDE 5 MG Oral Tablet	PSN	7ee41cd3-461f-3408-e053-2991aa0a863d	6
310537	glyburide 5 MG Oral Tablet	SCD	7ee41cd3-461f-3408-e053-2991aa0a863d	6
310537	glibenclamide 5 MG Oral Tablet	SY	7ee41cd3-461f-3408-e053-2991aa0a863d	6
310537	glyBURIDE 5 MG Oral Tablet	PSN	3e354b4d-70e4-5089-e054-00144ff88e88	4
310537	glyBURIDE 5 MG Oral Tablet	PSN	d9cb9251-7b31-72a0-e053-2a95a90a4315	4
310537	glyburide 5 MG Oral Tablet	SCD	d9cb9251-7b31-72a0-e053-2a95a90a4315	4
310537	glyburide 5 MG Oral Tablet	SCD	3e354b4d-70e4-5089-e054-00144ff88e88	4
310537	glibenclamide 5 MG Oral Tablet	SY	d9cb9251-7b31-72a0-e053-2a95a90a4315	4
310537	glibenclamide 5 MG Oral Tablet	SY	3e354b4d-70e4-5089-e054-00144ff88e88	4
310537	glyBURIDE 5 MG Oral Tablet	PSN	240c3ac6-9aab-4185-994e-a0254e3aeb61	3
310537	glyBURIDE 5 MG Oral Tablet	PSN	172ad55b-f2d2-4764-bcf6-8c209dd4b4a0	3
310537	glyBURIDE 5 MG Oral Tablet	PSN	901c50d5-31e7-b073-e053-2995a90abfeb	3
310537	glyBURIDE 5 MG Oral Tablet	PSN	a12342fb-123c-2951-e053-2a95a90ac596	3
310537	glyburide 5 MG Oral Tablet	SCD	901c50d5-31e7-b073-e053-2995a90abfeb	3
310537	glyburide 5 MG Oral Tablet	SCD	240c3ac6-9aab-4185-994e-a0254e3aeb61	3
310537	glyburide 5 MG Oral Tablet	SCD	172ad55b-f2d2-4764-bcf6-8c209dd4b4a0	3
310537	glyburide 5 MG Oral Tablet	SCD	a12342fb-123c-2951-e053-2a95a90ac596	3
310537	glibenclamide 5 MG Oral Tablet	SY	240c3ac6-9aab-4185-994e-a0254e3aeb61	3
310537	glibenclamide 5 MG Oral Tablet	SY	172ad55b-f2d2-4764-bcf6-8c209dd4b4a0	3
310537	glibenclamide 5 MG Oral Tablet	SY	901c50d5-31e7-b073-e053-2995a90abfeb	3
310537	glibenclamide 5 MG Oral Tablet	SY	a12342fb-123c-2951-e053-2a95a90ac596	3
310537	glyBURIDE 5 MG Oral Tablet	PSN	afef9998-82a2-4147-83d3-1cc457c34bf8	2
310537	glyBURIDE 5 MG Oral Tablet	PSN	d2ba6d99-9722-76d5-e053-2a95a90a6f50	2
310537	glyburide 5 MG Oral Tablet	SCD	afef9998-82a2-4147-83d3-1cc457c34bf8	2
310537	glyburide 5 MG Oral Tablet	SCD	d2ba6d99-9722-76d5-e053-2a95a90a6f50	2
310537	glibenclamide 5 MG Oral Tablet	SY	afef9998-82a2-4147-83d3-1cc457c34bf8	2
310537	glibenclamide 5 MG Oral Tablet	SY	d2ba6d99-9722-76d5-e053-2a95a90a6f50	2
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	11925cb1-aa29-2f64-e054-00144ff88e88	1
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	04201349-2a01-4fc1-9920-1ef7376d352f	1
310537	glyBURIDE 5 MG Oral Tablet	PSN	58200048-a278-4f9a-b705-affc358537fb	1
310537	glyBURIDE 5 MG Oral Tablet	PSN	2615ee96-7a3d-5cde-e054-00144ff8d46c	1
310537	glyBURIDE 5 MG Oral Tablet	PSN	04201349-2a01-4fc1-9920-1ef7376d352f	1
310537	glyBURIDE 5 MG Oral Tablet	PSN	11925cb1-aa29-2f64-e054-00144ff88e88	1
310534	glyburide 2.5 MG Oral Tablet	SCD	11925cb1-aa29-2f64-e054-00144ff88e88	1
310534	glyburide 2.5 MG Oral Tablet	SCD	04201349-2a01-4fc1-9920-1ef7376d352f	1
310537	glyburide 5 MG Oral Tablet	SCD	04201349-2a01-4fc1-9920-1ef7376d352f	1
310537	glyburide 5 MG Oral Tablet	SCD	58200048-a278-4f9a-b705-affc358537fb	1
310537	glyburide 5 MG Oral Tablet	SCD	11925cb1-aa29-2f64-e054-00144ff88e88	1
310537	glyburide 5 MG Oral Tablet	SCD	2615ee96-7a3d-5cde-e054-00144ff8d46c	1
310534	glibenclamide 2.5 MG Oral Tablet	SY	04201349-2a01-4fc1-9920-1ef7376d352f	1
310534	glibenclamide 2.5 MG Oral Tablet	SY	11925cb1-aa29-2f64-e054-00144ff88e88	1
310537	glibenclamide 5 MG Oral Tablet	SY	58200048-a278-4f9a-b705-affc358537fb	1
310537	glibenclamide 5 MG Oral Tablet	SY	04201349-2a01-4fc1-9920-1ef7376d352f	1
310537	glibenclamide 5 MG Oral Tablet	SY	11925cb1-aa29-2f64-e054-00144ff88e88	1
310537	glibenclamide 5 MG Oral Tablet	SY	2615ee96-7a3d-5cde-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-058-01	23155005801	100 TABLET in 1 BOTTLE (23155-058-01)	100 tablet	2010-10-05	0000-00-00	No	No	Current
23155-058-10	23155005810	1000 TABLET in 1 BOTTLE (23155-058-10)	1000 tablet	2010-10-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glyburide Tablets, USP 1.25, 2.5, and 5 mg	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Glyburide Tablets, USP 1.25, 2.5, and 5 mg	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| USV Private Limited	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	12
Glyburide	NuCare Pharmaceuticals,Inc.	2025-02-06	HUMAN PRESCRIPTION DRUG LABEL	6
Glyburide Tablets, USP 1.25, 2.5, and 5 mg	Bryant Ranch Prepack	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	103
for oral use	NuCare Pharmaceuticals, Inc.	2024-08-13	HUMAN PRESCRIPTION DRUG LABEL	4
Glyburide Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
Glyburide	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	3
Glyburide Tablets, USP 1.25, 2.5, and 5 mg	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	3
Glyburide Tablets, USP 1.25, 2.5, and 5 mg	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	11
Glyburide Tablets, USP 1.25, 2.5, and 5 mg	NuCare Pharmaceuticals,Inc.	2022-04-25	HUMAN PRESCRIPTION DRUG LABEL	2
for oral use	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
GLYBURIDE	DirectRX	2015-12-04	HUMAN PRESCRIPTION DRUG LABEL	1
Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg For Oral Use	Blenheim Pharmacal, Inc.	2015-03-18	HUMAN PRESCRIPTION DRUG LABEL	1
Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg For Oral Use	Aidarex Pharmaceuticals LLC	2014-01-04	HUMAN PRESCRIPTION DRUG LABEL	1
Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg For Oral Use	TYA Pharmaceuticals	2013-11-18	HUMAN PRESCRIPTION DRUG LABEL	2
Glyburide Tablets, USP 5 mg For Oral Use	Rebel Distributors Corp	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	1

GLYBURIDE

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#