Glipizide

Product NDC: 80425-0437
11-digit product format: 804250437
Labeler code: 80425
Product ID: 80425-0437_213c486b-f952-bffc-e063-6394a90a164e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA074497
Marketing category: ANDA
Marketing start: 2024-09-03
Substance: GLIPIZIDE
Active strength: 10 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074497-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB		1995-08-31
A074497-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB		1995-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074497-001	AB
A074497-002	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 · 86 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	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074497-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-08-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074497-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-08-31	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A074497-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074497-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074497-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074497-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074497-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074497-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074497-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074497-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074497-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074497-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074497-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074497-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074497-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074497-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074497-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074497-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074497-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074497-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074497-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074497-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074497-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074497-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074497-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074497-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074497-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074497-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074497-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074497-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074497-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074497-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074497-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074497-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074497-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074497-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074497-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074497-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074497-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074497-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074497-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074497-002	AB	1	`74a2ff9319b5…`

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	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
213c4e61-9bb7-9d1b-e063-6394a90a7339	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	SPL version
80425-0437-1	Glipizide	30 in 1 BOTTLE	TABLET	30	1
80425-0437-2	Glipizide	60 in 1 BOTTLE	TABLET	60	1
80425-0437-3	Glipizide	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0437-1	EA - Each	80425-0437	dda24d86-a621-473f-8bd4-8efa7f078856	1	2024-10-04
80425-0437-2	EA - Each	80425-0437	58d1cf56-3c82-43e4-b33d-a38eeb994140	1	2024-10-04
80425-0437-3	EA - Each	80425-0437	0e4231a0-6df4-433a-8f17-427483877c56	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0437	GLIPIZIDE TABLET [ADVANCED RX OF TENNESSEE, LLC]	1	Current NDC, 3 package rows	20240910_213c4e61-9bb7-9d1b-e063-6394a90a7339.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	00729e82-150a-464a-abe7-a3319721fbdb	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	a59e2aaf-692c-4696-817b-3fed7a9dc52c	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	c0db4c38-6eed-49ca-84ab-7ed89e476822	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	Golden State Medical Supply, Inc.	d91d021f-f644-eac7-e053-2995a90a81c4	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	ANI Pharmaceuticals, Inc.	252ba4e0-8dc3-43e3-be00-32570dc095bd	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	0b29837b-c39b-16d2-e063-6394a90abe61	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	A-S Medication Solutions	de67216c-4579-434e-b388-5e9b104f127a	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	A-S Medication Solutions	8948b81f-401c-478e-bb3d-3b0368f5ed8b	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497
Glipizide	GLIPIZIDE	Advanced Rx of Tennessee, LLC	213c4e61-9bb7-9d1b-e063-6394a90a7339	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497 ndc (product): 80425-0437
Glipizide	GLIPIZIDE	Aphena Pharma Solutions - Tennessee, LLC	64c2a82f-014c-47d7-b303-23531e6bb723	2023-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074497 application number: ANDA074497

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
310488	glipiZIDE 10 MG Oral Tablet	PSN	213c4e61-9bb7-9d1b-e063-6394a90a7339	1
310488	glipizide 10 MG Oral Tablet	SCD	213c4e61-9bb7-9d1b-e063-6394a90a7339	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0437-1	80425043701	30 TABLET in 1 BOTTLE (80425-0437-1)	30 tablet	2024-09-03	No	No	Current
80425-0437-2	80425043702	60 TABLET in 1 BOTTLE (80425-0437-2)	60 tablet	2024-09-03	No	No	Current
80425-0437-3	80425043703	90 TABLET in 1 BOTTLE (80425-0437-3)	90 tablet	2024-09-03	No	No	Current