Glipizide

Product NDC: 51655-361
11-digit product format: 516550361
Labeler code: 51655
Product ID: 51655-361_d4792b1b-f6c4-5b55-e053-2a95a90a0d35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glipizide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Northwind Pharmaceuticals
Application: NDA020329
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-05-28
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51655-361		D	Discontinued by firm		2026-08-17
excluded package	package	51655-361	51655-361-26	D	Discontinued by firm		2026-08-17

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51655-361-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51655-361-26	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020329-001	GLUCOTROL XL	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26
N020329-002	GLUCOTROL XL	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26
N020329-003	GLUCOTROL XL	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1999-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020329-001	AB
N020329-002	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 4 · 126 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
2026-08-18 06:07:40	2026-07	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1999-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1999-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1999-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1999-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1994-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1994-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1994-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1994-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	N020329-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020329-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020329-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020329-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020329-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020329-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020329-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020329-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020329-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020329-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020329-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020329-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020329-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020329-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020329-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020329-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020329-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020329-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020329-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020329-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020329-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020329-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020329-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020329-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020329-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020329-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020329-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020329-003	AB	1	`5c6f7cd8ea54…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020329-001	RE44459	2019-03-26	U-1431	2013-09-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020329-002	RE44459	2019-03-26	U-1431	2013-09-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020329-003	RE44459	2019-03-26	U-1431	2013-09-20	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020329-001	RE44459	2019-03-26	U-1431	2013-09-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020329-002	RE44459	2019-03-26	U-1431	2013-09-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020329-003	RE44459	2019-03-26	U-1431	2013-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020329-001	RE44459	2019-03-26	U-1431	2013-09-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020329-002	RE44459	2019-03-26	U-1431	2013-09-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020329-003	RE44459	2019-03-26	U-1431	2013-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020329-001	RE44459	2019-03-26	U-1431	2013-09-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020329-002	RE44459	2019-03-26	U-1431	2013-09-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020329-003	RE44459	2019-03-26	U-1431	2013-09-20	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-361-26	2023-12-18	C162847	48780-1	f386c649-9de0-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GLIPIZIDE XL safely and effectively. See full prescribing information for GLIPIZIDE XL. GLIPIZIDE XL ® (glipizide) extended release tablets, for oral use Initial U.S. Approval: 1994
51655-361-26	2023-01-30	C162847	48780-1	f386c649-9de0-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GLIPIZIDE XL safely and effectively. See full prescribing information for GLIPIZIDE XL. GLIPIZIDE XL ® (glipizide) extended release tablets, for oral use Initial U.S. Approval: 1994

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-361	GLIPIZIDE XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	3	Legacy NDC	20231219_ab6e676b-577d-79a4-e053-2995a90acda8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glucotrol XL	GLIPIZIDE	Roerig	eed99b60-d043-4249-9b2a-f05e46fb588d	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020329 application number: NDA020329

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
51655-361-26	51655036126	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-361-26)	2020-05-28	0000-00-00	No	No	Current