Application 074305

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLIPIZIDE	GLIPIZIDE	TABLET;ORAL	5MG	No	No
002	GLIPIZIDE	GLIPIZIDE	TABLET;ORAL	10MG	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
A074305-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB		1995-04-07
A074305-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB		1995-04-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074305-001	AB
A074305-002	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 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	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074305-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074305-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074305-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074305-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074305-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074305-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074305-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074305-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074305-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074305-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074305-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074305-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074305-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074305-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074305-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A074305-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074305-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A074305-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074305-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074305-002	AB	1	`cb3db0bc1861…`

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 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	667dd68a-d3e7-4b50-bd0a-d17783a090d5	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	00729e82-150a-464a-abe7-a3319721fbdb	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	a59e2aaf-692c-4696-817b-3fed7a9dc52c	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	c0db4c38-6eed-49ca-84ab-7ed89e476822	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
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
Glipizide	GLIPIZIDE	Golden State Medical Supply, Inc.	d91d021f-f644-eac7-e053-2995a90a81c4	2026-07-27	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	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

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1452	Glipizide	Glipizide	Sandoz Inc	ANDA	Current
0781-1453	Glipizide	Glipizide	Sandoz Inc	ANDA	Current
35356-899	Glipizide	Glipizide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-108	Glipizide	Glipizide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
53808-0258	Glipizide	Glipizide	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0259	Glipizide	Glipizide	State of Florida DOH Central Pharmacy	ANDA	Current
63187-234	Glipizide	Glipizide	Proficient Rx LP	ANDA	Current
63629-6476	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
63629-6476	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current
67046-237	Glipizide	Glipizide	Contract Pharmacy Services-PA	ANDA	Current
67296-0894	Glipizide	Glipizide	RedPharm Drug, Inc.	ANDA	Current
67296-0894	Glipizide	Glipizide	RedPharm Drug, Inc.	ANDA	Current
67544-097	Glipizide	Glipizide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-302	Glipizide	Glipizide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68645-150	Glipizide	Glipizide	Legacy Pharmaceutical Pac	ANDA	Current
68645-151	Glipizide	Glipizide	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68788-9176	Glipizide	Glipizide	Preferred Pharmaceuticals,Inc.	ANDA	Current
68788-9918	Glipizide	Glipizide	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0029	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70518-0029	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70518-0358	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current