Application 076159

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLIPIZIDE	GLIPIZIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No
002	GLIPIZIDE	GLIPIZIDE	TABLET, EXTENDED RELEASE;ORAL	5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076159-001	GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL			2013-09-20
A076159-002	GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL			2013-09-20

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 3 · 86 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
2026-09-14 22:38:34	2026-08	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076159-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076159-002	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A076159-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076159-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076159-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076159-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076159-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076159-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076159-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076159-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076159-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076159-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076159-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076159-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076159-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076159-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076159-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076159-002	AB	1	`ea99ee380514…`

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 3 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	e593552f-9817-4cb5-b491-31ea57dea4b8	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	9c9a3688-6de9-41db-af82-c4aa9b5b3f92	2026-02-20	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	f60b0690-aca9-40ec-956e-bd2ecc35ec54	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	383540fd-2931-49bf-8009-25e8f7fc9bda	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	a38cfe61-4aa5-498c-bca5-03a8213303bb	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	bde478e6-e290-47e0-9241-ce88d927633e	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	410bf280-838d-45af-9b60-15f94ded7581	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0ed5ed22-dd53-495d-bc10-0bede4d87926	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Rising Pharma Holdings, Inc.	0ffe361a-c99b-4f68-a7e2-a67a71c0c496	2026-01-17	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	AvPAK	aa1b16bf-e01c-d539-e053-2995a90a2735	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Aurobindo Pharma Limited	84794a52-b717-488c-8533-6425c83d405f	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northstar Rx LLC.	915636a4-092e-4e2e-9bc0-0d387d996977	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	c16edad6-4271-6ff0-e053-2a95a90a0240	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	3bb3b80a-30e8-62fe-e054-00144ff8d46c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	ab2f4ea6-46e8-268a-e053-2995a90a3977	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	ff9b3b7a-5ab1-45ec-e053-6294a90af426	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Proficient Rx LP	f5d7a98c-d1d4-43b9-8d7e-830a33ae0c24	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0a1e1152-ade7-2092-e063-6394a90a99e7	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0effd04d-172c-5d8c-e063-6294a90a93f4	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	16fb8bc7-1db1-477e-a201-b3b678b8a84c	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10370-745	Glipizide	Glipizide	Par Pharmaceutical, Inc.	ANDA	Current
10370-745	Glipizide	Glipizide	Par Pharmaceutical, Inc.	ANDA	Current
10370-745	Glipizide	Glipizide	Par Pharmaceutical, Inc.	ANDA	Current
10370-745	Glipizide	Glipizide	Par Pharmaceutical, Inc.	ANDA	Current
10370-746	Glipizide	Glipizide	Par Pharmaceutical, Inc.	ANDA	Current
10370-746	Glipizide	Glipizide	Par Pharmaceutical, Inc.	ANDA	Current
10370-746	Glipizide	Glipizide	Par Pharmaceutical, Inc.	ANDA	Current
10370-746	Glipizide	Glipizide	Par Pharmaceutical, Inc.	ANDA	Current
50090-2915	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
50090-2915	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
50090-3069	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
50090-3069	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
50090-3069	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
60760-745	Glipizide	Glipizide	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-746	Glipizide	Glipizide	St. Mary's Medical Park Pharmacy	ANDA	Current
63629-2202	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
63629-2202	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
63629-2203	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
63629-2203	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
63629-2204	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
63629-2204	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
63629-2205	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
63629-2205	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
63629-9281	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
68071-3141	Glipizide	Glipizide	NuCare Pharmaceuticals Inc,	ANDA	Current
68071-4020	Glipizide	Glipizide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7230	Glipizide	Glipizide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7230	Glipizide	Glipizide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7230	Glipizide	Glipizide	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0389	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
71335-0388	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
71335-0388	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
71335-0851	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
71335-0851	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current