Glipizide

Product NDC: 67046-0367
11-digit product format: 670460367
Labeler code: 67046
Product ID: 67046-0367_53e67073-8a11-c8b0-e063-6294a90a90cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA075795
Marketing category: ANDA
Marketing start: 2026-06-10
Substance: GLIPIZIDE
Active strength: 10 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS]; Sulfonylurea [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075795-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13
A075795-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075795-001	AB
A075795-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		2001-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		2001-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		2001-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		2001-06-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		2001-06-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075795-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075795-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075795-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075795-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075795-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075795-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075795-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075795-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075795-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075795-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075795-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075795-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075795-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075795-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075795-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075795-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075795-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075795-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075795-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075795-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075795-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075795-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075795-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075795-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075795-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075795-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075795-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075795-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075795-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075795-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075795-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075795-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075795-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075795-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075795-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075795-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075795-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075795-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075795-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075795-002	AB	1	`782e0a99824c…`

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
310488	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
53e650f1-f755-e3ad-e063-6294a90ae309	Available on FDA.report

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	376ce3cf-4e1b-4b5f-b3e7-cc9fc4a5aeb4	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	212897cb-7de7-4711-aaf4-44234f950e9f	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	American Health Packaging	ff6805bb-b5f0-46d3-bf1d-3333b63ff1ae	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Coupler LLC	53e650f1-f755-e3ad-e063-6294a90ae309	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795 ndc (product): 67046-0367
Glipizide	GLIPIZIDE	Coupler LLC	51b35391-7672-c02f-e063-6294a90af54e	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Cardinal Health 107, LLC	bf1f5a5d-79b0-4fc5-96f2-bd5119b56e2a	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals, Inc.	097424ef-612f-4bc2-809a-e5bb8eeae244	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Major Pharmaceuticals	d3b5677c-2265-47c8-beeb-bf12106056ba	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Legacy Pharmaceutical Packaging, LLC	116ffc6a-735c-49e0-a9d5-69b6bc3e3706	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	9c9a3688-6de9-41db-af82-c4aa9b5b3f92	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	f60b0690-aca9-40ec-956e-bd2ecc35ec54	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	383540fd-2931-49bf-8009-25e8f7fc9bda	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	a38cfe61-4aa5-498c-bca5-03a8213303bb	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0ed5ed22-dd53-495d-bc10-0bede4d87926	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	6282c653-9e9c-6810-e053-2991aa0a4a8e	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	AvPAK	aa1b16bf-e01c-d539-e053-2995a90a2735	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	c16edad6-4271-6ff0-e053-2a95a90a0240	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	16fb8bc7-1db1-477e-a201-b3b678b8a84c	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	1b2e5656-9da9-4fab-bf01-ed75896b836a	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Apotex Corp.	dcf426b8-bcdc-8214-a1b6-6388bd3399a0	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795

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	Sample	Status
67046-0367-3	67046036703	30 TABLET in 1 BLISTER PACK (67046-0367-3)	30 tablet	2026-06-10	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only	Coupler LLC \| Apotex Inc.	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	1