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 42.

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 · 84 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
2026-08-18 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…`
2022-03-09 01:35 UTC	2022-03	A076159-001	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076159-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2013-09-20	`bb7c543d1eb4…`

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 1 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	e4831ddb-9680-40cb-a060-4ba77c52d0aa	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	03151cb5-d32b-4484-8f2a-8c5d24c7f6f1	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	d9b6464f-6fe6-446e-8150-d0c15c46fee8	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	3de8b0a7-b848-40af-8406-fe6924ff41db	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	e0de2d19-b24b-46af-a10e-0b78c51350a4	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glucotrol XL	GLIPIZIDE	Roerig	eed99b60-d043-4249-9b2a-f05e46fb588d	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	ANI Pharmaceuticals, Inc.	252ba4e0-8dc3-43e3-be00-32570dc095bd	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	c2aadc88-22d2-467c-b2cb-03efb5a1f1c1	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	376ce3cf-4e1b-4b5f-b3e7-cc9fc4a5aeb4	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	212897cb-7de7-4711-aaf4-44234f950e9f	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	American Health Packaging	ff6805bb-b5f0-46d3-bf1d-3333b63ff1ae	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	St. Mary's Medical Park Pharmacy	1b2ef6e2-5e7c-761e-e063-6294a90addd0	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals, Inc.	4c4dfe64-d1c5-65ec-e063-6394a90aead5	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	06fb6c56-5609-41d9-8389-eba81432218d	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	5ca7e38b-84cb-4043-b97e-e2f5cd82b442	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Coupler LLC	53e650f1-f755-e3ad-e063-6294a90ae309	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	0df8f606-97b3-463c-a132-338cf4630a71	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	c8cfd137-7b41-460f-a463-141c9d1985ff	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	St. Mary's Medical Park Pharmacy	0ccc17ca-fff8-0449-e063-6294a90af36d	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	9b405ff3-6ce5-460a-9406-db92e0e6ab1b	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE

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