Glipizide

Product NDC: 0591-0461
11-digit product format: 005910461
Labeler code: 0591
Product ID: 0591-0461_72fa43ff-7f68-4fcf-9008-dc0ab36cf5d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA074223
Marketing category: ANDA
Marketing start: 1995-02-27
Substance: GLIPIZIDE
Active strength: 10 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: Glipizide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLIPIZIDE	10 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	X7WDT95N5C
Rxcui	310488, 310490

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09	Product name	2	20250625
b1de1ca9-d9db-4f4b-2103-09e2014d30d5	Product name	5	20180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0591-0461-01	Glipizide	100 in 1 BOTTLE, PLASTIC	TABLET	100	19
0591-0461-05	Glipizide	500 in 1 BOTTLE, PLASTIC	TABLET	500	19
0591-0461-10	Glipizide	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-0461-01	EA - Each	0591-0461	8aa4de3e-f915-405e-a042-619d864eb12e	1	2012-07-24
0591-0461-05	EA - Each	0591-0461	ebf6f90f-b5c4-4be7-b06f-73d5741f5fa4	1	2012-07-24
0591-0461-10	EA - Each	0591-0461	e74ae015-87a9-4d30-ba2e-8d44b2e02f45	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLIPIZIDE	ACTIVE INGREDIENT	X7WDT95N5C	GLIPIZIDE TABLET [WATSON LABORATORIES, INC.]	13
GLIPIZIDE	ACTIVE MOIETY	X7WDT95N5C	GLIPIZIDE TABLET [WATSON LABORATORIES, INC.]	13
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GLIPIZIDE TABLET [WATSON LABORATORIES, INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIPIZIDE TABLET [WATSON LABORATORIES, INC.]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GLIPIZIDE TABLET [WATSON LABORATORIES, INC.]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLIPIZIDE TABLET [WATSON LABORATORIES, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLIPIZIDE TABLET [WATSON LABORATORIES, INC.]	13
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GLIPIZIDE TABLET [WATSON LABORATORIES, INC.]	13
GLIPIZIDE	ACTIVE INGREDIENT	X7WDT95N5C	GLIPIZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
GLIPIZIDE	ACTIVE MOIETY	X7WDT95N5C	GLIPIZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GLIPIZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIPIZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLIPIZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GLIPIZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLIPIZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GLIPIZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
GLIPIZIDE	ACTIVE INGREDIENT	X7WDT95N5C	GLIPIZIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
GLIPIZIDE	ACTIVE MOIETY	X7WDT95N5C	GLIPIZIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GLIPIZIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIPIZIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLIPIZIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GLIPIZIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLIPIZIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GLIPIZIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
GLIPIZIDE	ACTIVE INGREDIENT	X7WDT95N5C	GLIPIZIDE TABLET [STAT RX USA LLC]	2
GLIPIZIDE	ACTIVE MOIETY	X7WDT95N5C	GLIPIZIDE TABLET [STAT RX USA LLC]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GLIPIZIDE TABLET [STAT RX USA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIPIZIDE TABLET [STAT RX USA LLC]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLIPIZIDE TABLET [STAT RX USA LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GLIPIZIDE TABLET [STAT RX USA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLIPIZIDE TABLET [STAT RX USA LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GLIPIZIDE TABLET [STAT RX USA LLC]	2
GLIPIZIDE	ACTIVE INGREDIENT	X7WDT95N5C	GLIPIZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
GLIPIZIDE	ACTIVE INGREDIENT	X7WDT95N5C	GLIPIZIDE TABLET [H.J. HARKINS COMPANY, INC.]	1
GLIPIZIDE	ACTIVE MOIETY	X7WDT95N5C	GLIPIZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
GLIPIZIDE	ACTIVE MOIETY	X7WDT95N5C	GLIPIZIDE TABLET [H.J. HARKINS COMPANY, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GLIPIZIDE TABLET [H.J. HARKINS COMPANY, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GLIPIZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIPIZIDE TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIPIZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLIPIZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLIPIZIDE TABLET [H.J. HARKINS COMPANY, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GLIPIZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GLIPIZIDE TABLET [H.J. HARKINS COMPANY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLIPIZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLIPIZIDE TABLET [H.J. HARKINS COMPANY, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GLIPIZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GLIPIZIDE TABLET [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-0461	GLIPIZIDE TABLET [ACTAVIS PHARMA, INC.]	19	Current NDC, Legacy NDC, 3 package rows	20241106_ad55dfd7-ffb5-478a-aa84-1009fa921e22.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X7WDT95N5C	GLIPIZIDE	29094-61-9	GLIPIZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310488	glipiZIDE 10 MG Oral Tablet	PSN	ad55dfd7-ffb5-478a-aa84-1009fa921e22	19
310490	glipiZIDE 5 MG Oral Tablet	PSN	ad55dfd7-ffb5-478a-aa84-1009fa921e22	19
310488	glipizide 10 MG Oral Tablet	SCD	ad55dfd7-ffb5-478a-aa84-1009fa921e22	19
310490	glipizide 5 MG Oral Tablet	SCD	ad55dfd7-ffb5-478a-aa84-1009fa921e22	19
310488	glipiZIDE 10 MG Oral Tablet	PSN	d5398166-5698-4ee5-bd41-3c24e4445b53	6
310488	glipiZIDE 10 MG Oral Tablet	PSN	5c627a52-e4ca-7103-e053-2a91aa0ae13f	6
310488	glipiZIDE 10 MG Oral Tablet	PSN	3bb3b80a-30e8-62fe-e054-00144ff8d46c	6
310488	glipizide 10 MG Oral Tablet	SCD	d5398166-5698-4ee5-bd41-3c24e4445b53	6
310488	glipizide 10 MG Oral Tablet	SCD	5c627a52-e4ca-7103-e053-2a91aa0ae13f	6
310488	glipizide 10 MG Oral Tablet	SCD	3bb3b80a-30e8-62fe-e054-00144ff8d46c	6
310488	glipiZIDE 10 MG Oral Tablet	PSN	02857195-33e9-4c1f-9e5f-7cc62f283649	5
310488	glipiZIDE 10 MG Oral Tablet	PSN	bf5ff427-3ee4-4064-a55e-35daa2f12a06	5
310490	glipiZIDE 5 MG Oral Tablet	PSN	bf5ff427-3ee4-4064-a55e-35daa2f12a06	5
310488	glipizide 10 MG Oral Tablet	SCD	02857195-33e9-4c1f-9e5f-7cc62f283649	5
310488	glipizide 10 MG Oral Tablet	SCD	bf5ff427-3ee4-4064-a55e-35daa2f12a06	5
310490	glipizide 5 MG Oral Tablet	SCD	bf5ff427-3ee4-4064-a55e-35daa2f12a06	5
310488	glipiZIDE 10 MG Oral Tablet	PSN	06505b04-656c-47ef-83ba-ab977bdcaaf4	4
310488	glipiZIDE 10 MG Oral Tablet	PSN	7c21db4d-6b9b-36c3-e053-2991aa0a0fd9	4
310490	glipiZIDE 5 MG Oral Tablet	PSN	06505b04-656c-47ef-83ba-ab977bdcaaf4	4
310488	glipizide 10 MG Oral Tablet	SCD	06505b04-656c-47ef-83ba-ab977bdcaaf4	4
310488	glipizide 10 MG Oral Tablet	SCD	7c21db4d-6b9b-36c3-e053-2991aa0a0fd9	4
310490	glipizide 5 MG Oral Tablet	SCD	06505b04-656c-47ef-83ba-ab977bdcaaf4	4
310488	glipiZIDE 10 MG Oral Tablet	PSN	1b2be017-5c70-4d87-9538-53876a815410	3
310488	glipiZIDE 10 MG Oral Tablet	PSN	3030da52-4e59-44d0-9d62-4b27e38e7e91	3
310490	glipiZIDE 5 MG Oral Tablet	PSN	3030da52-4e59-44d0-9d62-4b27e38e7e91	3
310488	glipizide 10 MG Oral Tablet	SCD	3030da52-4e59-44d0-9d62-4b27e38e7e91	3
310488	glipizide 10 MG Oral Tablet	SCD	1b2be017-5c70-4d87-9538-53876a815410	3
310490	glipizide 5 MG Oral Tablet	SCD	3030da52-4e59-44d0-9d62-4b27e38e7e91	3
310488	glipiZIDE 10 MG Oral Tablet	PSN	056a5580-52cd-4055-b23a-b343605229ad	2
310490	glipiZIDE 5 MG Oral Tablet	PSN	056a5580-52cd-4055-b23a-b343605229ad	2
310488	glipizide 10 MG Oral Tablet	SCD	056a5580-52cd-4055-b23a-b343605229ad	2
310490	glipizide 5 MG Oral Tablet	SCD	056a5580-52cd-4055-b23a-b343605229ad	2
310488	glipiZIDE 10 MG Oral Tablet	PSN	e253ec37-78bb-4168-b630-2b7e33607f9d	1
310488	glipiZIDE 10 MG Oral Tablet	PSN	fc190807-9e35-4cfe-a1db-a31883104e91	1
310488	glipiZIDE 10 MG Oral Tablet	PSN	0a280a88-5973-4d0f-9b25-9be0c96e49c7	1
310488	glipiZIDE 10 MG Oral Tablet	PSN	0874340a-75a1-4ac9-b224-80c5c24e1b41	1
310490	glipiZIDE 5 MG Oral Tablet	PSN	e253ec37-78bb-4168-b630-2b7e33607f9d	1
310488	glipizide 10 MG Oral Tablet	SCD	0874340a-75a1-4ac9-b224-80c5c24e1b41	1
310488	glipizide 10 MG Oral Tablet	SCD	e253ec37-78bb-4168-b630-2b7e33607f9d	1
310488	glipizide 10 MG Oral Tablet	SCD	0a280a88-5973-4d0f-9b25-9be0c96e49c7	1
310488	glipizide 10 MG Oral Tablet	SCD	fc190807-9e35-4cfe-a1db-a31883104e91	1
310490	glipizide 5 MG Oral Tablet	SCD	e253ec37-78bb-4168-b630-2b7e33607f9d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-0461-00	00591046100	24000 TABLET in 1 BAG (0591-0461-00)	24000 tablet	27-FEB-95				Current
0591-0461-01	00591046101	100 TABLET in 1 BOTTLE, PLASTIC (0591-0461-01)	100 tablet	1995-02-27	0000-00-00	No	No	Current
0591-0461-05	00591046105	500 TABLET in 1 BOTTLE, PLASTIC (0591-0461-05)	500 tablet	1995-02-27	0000-00-00	No	No	Current
0591-0461-10	00591046110	1000 TABLET in 1 BOTTLE, PLASTIC (0591-0461-10)	1000 tablet	1995-02-27	0000-00-00	No	No	Current
0591-0461-77	00591046177	28464 TABLET in 1 CONTAINER (0591-0461-77)	28464 tablet	16-JAN-24				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
glipiZIDE Tablets, USP for oral use Rx only	Preferred Pharmaceuticals Inc..	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	5
glipiZIDE Tablets, USP for oral use Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	6
Glipizide Tablets, USP for oral use Revised: June 2015 Rx only	Proficient Rx LP	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	6
Glipizide Tablets, USP for oral use Revised: June 2015 Rx only	NuCare Pharmaceuticals,Inc.	2025-08-08	HUMAN PRESCRIPTION DRUG LABEL	6
Glipizide Tablets, USP for oral use Revised: June 2015 Rx only	NuCare Pharmaceuticals,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	4
glipiZIDE Tablets, USP for oral use Rx only	Actavis Pharma, Inc.	2023-12-31	HUMAN PRESCRIPTION DRUG LABEL	19
GlipiZIDE Tablets, USP for oral use Rx only	A-S Medication Solutions	2023-12-28	HUMAN PRESCRIPTION DRUG LABEL	1
GlipiZIDE Tablets, USP for oral use Rx only	RPK Pharmaceuticals, Inc.	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	3
GlipiZIDE Tablets, USP for oral use Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2023-02-27	HUMAN PRESCRIPTION DRUG LABEL	5
Glipizide Tablets, USP for oral use Revised: June 2015 Rx only	Aphena Pharma Solutions - Tennessee, LLC	2019-05-28	HUMAN PRESCRIPTION DRUG LABEL	1
Glipizide Tablets USP Revised: November 2008 Rx only 174347	Blenheim Pharmacal, Inc.	2015-03-23	HUMAN PRESCRIPTION DRUG LABEL	3
Glipizide Tablets USP Revised: November 2008 Rx only 174347	Physicians Total Care, Inc.	2012-11-05	HUMAN PRESCRIPTION DRUG LABEL	4
Glipizide Tablets USP Revised: November 2008 Rx only 174347	STAT Rx USA LLC \| PSS World Medical Inc.	2012-08-27	HUMAN PRESCRIPTION DRUG LABEL	2
Glipizide Tablets USP Revised: November 2008 Rx only 174347	H.J. Harkins Company, Inc. \| Watson Laboratories, Inc. \| Watson Pharma Private Limited	2011-09-15	HUMAN PRESCRIPTION DRUG LABEL	1
Glipizide Tablets USP Rx only 174347	Rebel Distributors Corp	2011-06-28	HUMAN PRESCRIPTION DRUG LABEL	1

Glipizide

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#