Glipizide

Product NDC: 60760-165
11-digit product format: 607600165
Labeler code: 60760
Product ID: 60760-165_903cb974-e615-1a0e-e053-2a95a90a4306
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA204720
Marketing category: ANDA
Marketing start: 2019-08-12
Marketing end: 0000-00-00
Substance: GLIPIZIDE
Active strength: 5 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	60760-165		D	Discontinued by firm		2026-08-11
excluded package	package	60760-165	60760-165-30	D	Discontinued by firm		2026-08-11

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	TE codes	RLD / RS	Approval date
A204720-001	GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29
A204720-002	GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29
A204720-003	GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204720-001	AB
A204720-002	AB
A204720-003	AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204720-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204720-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204720-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204720-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204720-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204720-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204720-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204720-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204720-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204720-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-165-30	EA - Each	60760-165	0aa753d4-c966-4a5f-84b8-abee524870a8	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-165	GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]	2	Legacy NDC	20250110_903ccbf6-b11e-4271-e053-2a95a90a8e93.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	03151cb5-d32b-4484-8f2a-8c5d24c7f6f1	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	c2aadc88-22d2-467c-b2cb-03efb5a1f1c1	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	548c1f50-dbf0-49cc-b58b-fcc5937affa8	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	4632b4ec-d2f1-40cc-8ef4-256413d8dbec	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	A-S Medication Solutions	a34b58ac-42b2-4a19-a28b-cb3144ea55cd	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	bde478e6-e290-47e0-9241-ce88d927633e	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Rising Pharma Holdings, Inc.	0ffe361a-c99b-4f68-a7e2-a67a71c0c496	2026-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	ab2f4ea6-46e8-268a-e053-2995a90a3977	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	ff9b3b7a-5ab1-45ec-e053-6294a90af426	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	0338aff9-29f9-405e-b516-06ef4b863863	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	A-S Medication Solutions	4982f018-c53c-48ec-a4e8-4834228bcf2c	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60760-165-30	60760016530	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-165-30)	2019-08-12	0000-00-00	No	No	Current