Glipizide

Product NDC: 68788-8487
Requested package NDC: 68788-8487-9
11-digit product format: 687888487
Labeler code: 68788
Product ID: 68788-8487_65b42af8-9841-464c-b72e-d3a9f84523cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA204720
Marketing category: ANDA
Marketing start: 2023-07-19
Substance: GLIPIZIDE
Active strength: 2.5 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204720-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204720-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204720-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-12-29	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204720-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204720-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204720-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204720-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204720-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204720-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Glipizide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLIPIZIDE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X7WDT95N5C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310489	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4632b4ec-d2f1-40cc-8ef4-256413d8dbec	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09	Product name	2	20250625
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
b1de1ca9-d9db-4f4b-2103-09e2014d30d5	Product name	5	20180912
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-8487-1	Glipizide	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	100	4
68788-8487-3	Glipizide	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30	4
68788-8487-6	Glipizide	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60	4
68788-8487-9	Glipizide	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8487-1	EA - Each	68788-8487	8223b2cd-2733-48dd-860c-39cee6bbf5a1	1	2023-09-05
68788-8487-3	EA - Each	68788-8487	a59e9d46-be1a-4a3d-accc-e119ec4810c9	1	2023-09-05
68788-8487-6	EA - Each	68788-8487	80a3b846-bfda-42c6-8be2-34998128e1cf	1	2023-09-05
68788-8487-9	EA - Each	68788-8487	61c108f6-b041-41e7-a947-a796e05eafdb	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8487	GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]	2	Current NDC, 4 package rows	20240514_4632b4ec-d2f1-40cc-8ef4-256413d8dbec.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 · 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 ndc (package): 68788-8487-9 ndc (product): 68788-8487 ndc11 (package): 68788848709
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310489	glipiZIDE 2.5 MG 24HR Extended Release Oral Tablet	PSN	4632b4ec-d2f1-40cc-8ef4-256413d8dbec	4
310489	24 HR glipizide 2.5 MG Extended Release Oral Tablet	SCD	4632b4ec-d2f1-40cc-8ef4-256413d8dbec	4
310489	glipizide ER 2.5 MG 24 HR Extended Release Oral Tablet	SY	4632b4ec-d2f1-40cc-8ef4-256413d8dbec	4
310489	glipizide XL 2.5 MG 24 HR Extended Release Oral Tablet	SY	4632b4ec-d2f1-40cc-8ef4-256413d8dbec	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68788-8487-9	68788848709	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-8487-9)	2023-07-19	No	No	Current