Glipizide

Product NDC: 82868-025
11-digit product format: 828680025
Labeler code: 82868
Product ID: 82868-025_46dc8f32-692a-a243-e063-6394a90a19f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA206928
Marketing category: ANDA
Marketing start: 2023-11-08
Substance: GLIPIZIDE
Active strength: 5 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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	Approval date
A206928-001	GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12
A206928-002	GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12
A206928-003	GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206928-001	AB
A206928-002	AB
A206928-003	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`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	A206928-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206928-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206928-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206928-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206928-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206928-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206928-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206928-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206928-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206928-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206928-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206928-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206928-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206928-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206928-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206928-001	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLIPIZIDE	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
314006	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
0a1e1152-ade7-2092-e063-6394a90a99e7	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
b1de1ca9-d9db-4f4b-2103-09e2014d30d5	Product name	5	20180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82868-025-30	Glipizide	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30		3
82868-025-90	Glipizide	90 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82868-025	GLIPIZIDE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	2	Current NDC, 2 package rows	20240127_0a1e1152-ade7-2092-e063-6394a90a99e7.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 · 13 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	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	St. Mary's Medical Park Pharmacy	1b2ef6e2-5e7c-761e-e063-6294a90addd0	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	0df8f606-97b3-463c-a132-338cf4630a71	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	St. Mary's Medical Park Pharmacy	0ccc17ca-fff8-0449-e063-6294a90af36d	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	2aa01a7e-a703-426f-9cd3-70b88d0a8e7f	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	ceb86ebb-d00a-4261-90ad-8751e799d93c	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	4afa67b2-7f86-4189-93a5-6a605f74540d	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Aurobindo Pharma Limited	84794a52-b717-488c-8533-6425c83d405f	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0a1e1152-ade7-2092-e063-6394a90a99e7	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928 ndc (product): 82868-025
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0effd04d-172c-5d8c-e063-6294a90a93f4	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	American Health Packaging	aaf029d3-027e-4ae8-8ec5-3a4c16f9bd28	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	A-S Medication Solutions	08b01608-73c2-45e0-8de4-c6c401261152	2023-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	A-S Medication Solutions	695c178f-77f0-451e-b718-72b65e495b7e	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928

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
314006	glipiZIDE 5 MG 24HR Extended Release Oral Tablet	PSN	0a1e1152-ade7-2092-e063-6394a90a99e7	3
314006	24 HR glipizide 5 MG Extended Release Oral Tablet	SCD	0a1e1152-ade7-2092-e063-6394a90a99e7	3
314006	glipizide ER 5 MG 24 HR Extended Release Oral Tablet	SY	0a1e1152-ade7-2092-e063-6394a90a99e7	3
314006	glipizide XL 5 MG 24 HR Extended Release Oral Tablet	SY	0a1e1152-ade7-2092-e063-6394a90a99e7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82868-025-30	82868002530	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-025-30)	2024-01-03	No	No	Current
82868-025-90	82868002590	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-025-90)	2023-11-08	No	No	Current