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 4 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	A-S Medication Solutions	3b111484-78ef-4db9-95ee-6cc4b6acdd59	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	155216cf-4bad-479a-83b6-032d4bd11c2e	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	c829b7bf-1a12-44b2-b5ce-fd44a1f0d333	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Proficient Rx LP	d5398166-5698-4ee5-bd41-3c24e4445b53	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Advanced Rx of Tennessee, LLC	3d87cc75-7a0d-46a2-e063-6294a90a6d49	2025-08-29	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	4d490a3a-abdc-4ff4-83fb-f302f51e3023	2025-08-29	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	5c627a52-e4ca-7103-e053-2a91aa0ae13f	2025-08-08	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	1b2e5656-9da9-4fab-bf01-ed75896b836a	2025-07-17	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	American Health Packaging	aaf029d3-027e-4ae8-8ec5-3a4c16f9bd28	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	b31ab6dd-0277-43ee-a054-f20c462f0c56	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	0b29837b-c39b-16d2-e063-6394a90abe61	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Proficient Rx LP	6427db20-6783-439f-8c2d-64d1a6fcb9fc	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	86e6583c-b290-e2b5-e053-2991aa0ab485	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	0338aff9-29f9-405e-b516-06ef4b863863	2024-12-20	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	de67216c-4579-434e-b388-5e9b104f127a	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	8948b81f-401c-478e-bb3d-3b0368f5ed8b	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	4995328f-287c-4d4a-9b5f-9d354cc530fb	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	abab5b07-08eb-4416-ae03-3656a078caa2	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	be20727f-2724-457a-89ac-aa96604a0015	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	560448dd-3690-43d9-9667-925f20bb816e	2024-10-04	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