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 5 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	Advanced Rx of Tennessee, LLC	213c4e61-9bb7-9d1b-e063-6394a90a7339	2024-09-03	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	afb65cc1-a4fb-4771-b09c-dcf6e8c5786e	2024-08-26	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals, Inc.	3e295cbc-37c1-4e25-e054-00144ff8d46c	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	589dc76d-c347-0589-e053-2991aa0a2520	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	8c27962d-626b-30e6-e053-2a95a90a49c6	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	7c21db4d-6b9b-36c3-e053-2991aa0a0fd9	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	62d569b8-bb34-0e06-e053-2a91aa0a2ae1	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Aphena Pharma Solutions - Tennessee, LLC	f620559f-985b-421f-98df-bc2ca1cb0ece	2024-02-26	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Actavis Pharma, Inc.	ad55dfd7-ffb5-478a-aa84-1009fa921e22	2023-12-31	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	0874340a-75a1-4ac9-b224-80c5c24e1b41	2023-12-28	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c	2023-12-04	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	15308fc4-11e3-4cd5-8f04-ab8e3433cc7d	2023-12-04	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	4982f018-c53c-48ec-a4e8-4834228bcf2c	2023-11-24	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	08b01608-73c2-45e0-8de4-c6c401261152	2023-10-23	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	695c178f-77f0-451e-b718-72b65e495b7e	2023-10-18	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	TruPharma LLC	95ea4c96-84b9-4515-9494-a93d26820f70	2023-10-11	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Aphena Pharma Solutions - Tennessee, LLC	64c2a82f-014c-47d7-b303-23531e6bb723	2023-04-14	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	bf5ff427-3ee4-4064-a55e-35daa2f12a06	2023-02-27	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Proficient Rx LP	f280acc1-d912-4f2e-b131-440e708c7b1f	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Proficient Rx LP	31618a34-b87b-484c-8b65-1f77d8cd0f28	2022-04-01	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