Application 078728

Type: ANDA
Sponsor: HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;250MG	No	No
002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;500MG	No	No
003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	TABLET;ORAL	5MG;500MG	No	No

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	Approval date
A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23
A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23
A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078728-001	AB
A078728-002	AB
A078728-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`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	A078728-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078728-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078728-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078728-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078728-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078728-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078728-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078728-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078728-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078728-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide and Metformin HCl	GLIPIZIDE AND METFORMIN HCL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	94a7f96e-2ed1-432d-bc6a-5840863816e1	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078728 application number: ANDA078728 ndc (product): 23155-115 ndc (product): 23155-117 ndc (product): 23155-116
Glipizide and metformin hcl	GLIPIZIDE AND METFORMIN HCL	Chartwell RX, LLC	ac018f64-fd9d-4b3c-b0ac-ca305b8df635	2025-12-10	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 078728 application number: ANDA078728
Glipizide and Metformin HCl	GLIPIZIDE AND METFORMIN HCL	Proficient Rx LP	be4d2552-c964-4d09-ba7a-0d94320f968c	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078728 application number: ANDA078728 ndc (product): 71205-270

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-115	glipizide and metformin hcl	glipizide and metformin hcl	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-115	Glipizide and Metformin HCl	Glipizide and Metformin HCl	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-116	glipizide and metformin hcl	glipizide and metformin hcl	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-116	Glipizide and Metformin HCl	Glipizide and Metformin HCl	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-117	glipizide and metformin hcl	glipizide and metformin hcl	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-117	Glipizide and Metformin HCl	Glipizide and Metformin HCl	Heritage Pharmaceuticals Inc.	ANDA	Current
50090-1082	glipizide and metformin hcl	glipizide and metformin hcl	A-S Medication Solutions	ANDA	Current
70518-1594	Glipizide and Metformin HCl	Glipizide and Metformin HCl	REMEDYREPACK INC.	ANDA	Current
70518-1594	Glipizide and Metformin HCl	Glipizide and Metformin HCl	REMEDYREPACK INC.	ANDA	Current
70518-1594	glipizide and metformin hcl	glipizide and metformin hcl	REMEDYREPACK INC.	ANDA	Current
70518-2196	Glipizide and Metformin HCl	Glipizide and Metformin HCl	REMEDYREPACK INC.	ANDA	Current
70518-2196	Glipizide and Metformin HCl	Glipizide and Metformin HCl	REMEDYREPACK INC.	ANDA	Current
70518-2196	glipizide and metformin hcl	glipizide and metformin hcl	REMEDYREPACK INC.	ANDA	Current
70518-2196	glipizide and metformin hcl	glipizide and metformin hcl	REMEDYREPACK INC.	ANDA	Current
71205-270	Glipizide and Metformin HCl	Glipizide and Metformin HCl	Proficient Rx LP	ANDA	Current
71205-270	Glipizide and Metformin HCl	Glipizide and Metformin HCl	Proficient Rx LP	ANDA	Current