Glipizide

Product NDC: 68071-4378
Requested package NDC: 68071-4378-6
11-digit product format: 680714378
Labeler code: 68071
Product ID: 68071-4378_bb7bdc98-4f5b-83d5-e053-2a95a90a7feb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA204720
Marketing category: ANDA
Marketing start: 2017-04-24
Marketing end: 0000-00-00
Substance: GLIPIZIDE
Active strength: 5 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-4378	68071-4378-6	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204720-001	GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29
A204720-002	GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29
A204720-003	GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204720-001	AB
A204720-002	AB
A204720-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204720-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204720-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204720-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204720-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204720-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204720-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204720-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204720-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204720-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204720-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204720-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204720-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204720-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204720-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204720-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204720-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204720-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204720-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204720-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204720-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-4378-2	2024-06-07	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-3	2024-06-07	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-6	2024-06-07	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-8	2024-06-07	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-9	2024-06-07	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-2	2023-01-30	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-3	2023-01-30	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-6	2023-01-30	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-8	2023-01-30	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-9	2023-01-30	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-2	2021-02-16	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-3	2021-02-16	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-6	2021-02-16	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-8	2021-02-16	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-9	2021-02-16	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-2	2021-01-29	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-3	2021-01-29	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-6	2021-01-29	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-8	2021-01-29	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994
68071-4378-9	2021-01-29	These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE EXTENDED-RELEASE TABLETS, for oral use Initial U.S. Approval: 1994

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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	03151cb5-d32b-4484-8f2a-8c5d24c7f6f1	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	c2aadc88-22d2-467c-b2cb-03efb5a1f1c1	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	548c1f50-dbf0-49cc-b58b-fcc5937affa8	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	4632b4ec-d2f1-40cc-8ef4-256413d8dbec	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	A-S Medication Solutions	a34b58ac-42b2-4a19-a28b-cb3144ea55cd	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	bde478e6-e290-47e0-9241-ce88d927633e	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Rising Pharma Holdings, Inc.	0ffe361a-c99b-4f68-a7e2-a67a71c0c496	2026-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	ab2f4ea6-46e8-268a-e053-2995a90a3977	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	ff9b3b7a-5ab1-45ec-e053-6294a90af426	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	0338aff9-29f9-405e-b516-06ef4b863863	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720
Glipizide	GLIPIZIDE	A-S Medication Solutions	4982f018-c53c-48ec-a4e8-4834228bcf2c	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204720 application number: ANDA204720

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X7WDT95N5C	GLIPIZIDE	29094-61-9	GLIPIZIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4378-6	68071437806	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-4378-6)	2018-04-05	0000-00-00	No	No	Current