Glipizide

Product NDC: 68788-8192
11-digit product format: 687888192
Labeler code: 68788
Product ID: 68788-8192_426f1221-b86d-4ccf-995e-9bf78337ce6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA074497
Marketing category: ANDA
Marketing start: 2022-05-16
Marketing end: 0000-00-00
Substance: GLIPIZIDE
Active strength: 10 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-8192		D	Discontinued by firm	2026-08-17
excluded package	package	68788-8192	68788-8192-1	D	Discontinued by firm	2026-08-17
excluded package	package	68788-8192	68788-8192-3	D	Discontinued by firm	2026-08-17
excluded package	package	68788-8192	68788-8192-6	D	Discontinued by firm	2026-08-17
excluded package	package	68788-8192	68788-8192-8	D	Discontinued by firm	2026-08-17
excluded package	package	68788-8192	68788-8192-9	D	Discontinued by firm	2026-08-17

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
A074497-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB		1995-08-31
A074497-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB		1995-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074497-001	AB
A074497-002	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 · 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	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074497-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074497-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074497-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074497-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074497-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074497-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074497-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074497-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074497-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074497-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074497-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074497-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074497-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074497-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074497-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074497-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074497-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074497-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074497-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074497-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074497-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074497-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074497-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074497-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074497-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074497-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074497-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074497-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074497-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074497-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074497-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074497-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074497-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074497-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074497-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074497-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074497-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074497-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074497-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074497-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8192-1	EA - Each	68788-8192	1ac66461-815c-4477-8ce1-075497a3192a	1	2022-07-06
68788-8192-3	EA - Each	68788-8192	9b29675e-a90c-45bd-b7c8-0fd097b93413	1	2022-07-06
68788-8192-6	EA - Each	68788-8192	2b0aa6d8-52ab-473c-9878-3f643dcc1d17	1	2022-07-06
68788-8192-8	EA - Each	68788-8192	586864bb-9d54-4a99-9b5e-99da34d200c1	1	2022-07-06
68788-8192-9	EA - Each	68788-8192	0884e675-f104-4f45-bd34-d64c76e1b130	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8192	GLIPIZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3	Legacy NDC	20240516_426f1221-b86d-4ccf-995e-9bf78337ce6b.zip

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	ANI Pharmaceuticals, Inc.	252ba4e0-8dc3-43e3-be00-32570dc095bd	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	a59e2aaf-692c-4696-817b-3fed7a9dc52c	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	00729e82-150a-464a-abe7-a3319721fbdb	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	Golden State Medical Supply, Inc.	d91d021f-f644-eac7-e053-2995a90a81c4	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	0b29837b-c39b-16d2-e063-6394a90abe61	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	c0db4c38-6eed-49ca-84ab-7ed89e476822	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	A-S Medication Solutions	de67216c-4579-434e-b388-5e9b104f127a	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	A-S Medication Solutions	8948b81f-401c-478e-bb3d-3b0368f5ed8b	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	Advanced Rx of Tennessee, LLC	213c4e61-9bb7-9d1b-e063-6394a90a7339	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	Aphena Pharma Solutions - Tennessee, LLC	64c2a82f-014c-47d7-b303-23531e6bb723	2023-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8192-1	68788819201	100 TABLET in 1 BOTTLE (68788-8192-1)	100 tablet	2022-05-16	0000-00-00	No	No	Current
68788-8192-3	68788819203	30 TABLET in 1 BOTTLE (68788-8192-3)	30 tablet	2022-05-16	0000-00-00	No	No	Current
68788-8192-6	68788819206	60 TABLET in 1 BOTTLE (68788-8192-6)	60 tablet	2022-05-16	0000-00-00	No	No	Current
68788-8192-8	68788819208	180 TABLET in 1 BOTTLE (68788-8192-8)	180 tablet	2022-05-16	0000-00-00	No	No	Current
68788-8192-9	68788819209	90 TABLET in 1 BOTTLE (68788-8192-9)	90 tablet	2022-05-16	0000-00-00	No	No	Current