Glipizide

Product NDC: 51655-966
11-digit product format: 516550966
Labeler code: 51655
Product ID: 51655-966_4bc1b84a-aaee-d6e6-e063-6294a90a0762
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA204720
Marketing category: ANDA
Marketing start: 2023-06-27
Substance: GLIPIZIDE
Active strength: 10 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 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
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 · 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	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…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	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…`
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLIPIZIDE	10 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
315107	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
ff9b3b7a-5ab1-45ec-e053-6294a90af426	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
51655-966-26	Glipizide	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90		5
51655-966-52	Glipizide	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-966	GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	2	Current NDC, 2 package rows	20240127_ff9b3b7a-5ab1-45ec-e053-6294a90af426.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
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 ndc (product): 51655-966
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
315107	glipiZIDE 10 MG 24HR Extended Release Oral Tablet	PSN	ff9b3b7a-5ab1-45ec-e053-6294a90af426	5
315107	24 HR glipizide 10 MG Extended Release Oral Tablet	SCD	ff9b3b7a-5ab1-45ec-e053-6294a90af426	5
315107	glipizide ER 10 MG 24 HR Extended Release Oral Tablet	SY	ff9b3b7a-5ab1-45ec-e053-6294a90af426	5
315107	glipizide XL 10 MG 24 HR Extended Release Oral Tablet	SY	ff9b3b7a-5ab1-45ec-e053-6294a90af426	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51655-966-26	51655096626	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-966-26)	2023-07-31	No	No	Current
51655-966-52	51655096652	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-966-52)	2023-06-27	No	No	Current