Glipizide

Product NDC: 82804-174
Requested package NDC: 82804-174-90
11-digit product format: 828040174
Labeler code: 82804
Product ID: 82804-174_abe14fb1-e2fa-4c89-8007-fa4c18fd70a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA214874
Marketing category: ANDA
Marketing start: 2023-10-03
Substance: GLIPIZIDE
Active strength: 5 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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214874-001	GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03
A214874-002	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03
A214874-003	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03
A214874-004	GLIPIZIDE	GLIPIZIDE	15MG	TABLET / ORAL		RS	2026-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214874-002	AB
A214874-003	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 2 · 70 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
2026-09-14 22:38:34	2026-08	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214874-004	GLIPIZIDE	15MG	TABLET / ORAL		RS	2026-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214874-004	GLIPIZIDE	15MG	TABLET / ORAL		RS	2026-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214874-004	GLIPIZIDE	15MG	TABLET / ORAL		RS	2026-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214874-002	GLIPIZIDE	5MG	TABLET / ORAL	AB		2023-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214874-003	GLIPIZIDE	10MG	TABLET / ORAL	AB		2023-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214874-001	GLIPIZIDE	2.5MG	TABLET / ORAL			2023-10-03	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A214874-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214874-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214874-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214874-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214874-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214874-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214874-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214874-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214874-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214874-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214874-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214874-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214874-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214874-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214874-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214874-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214874-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214874-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214874-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214874-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214874-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214874-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214874-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214874-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214874-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214874-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214874-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214874-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214874-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214874-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214874-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214874-003	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214874-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214874-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214874-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214874-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214874-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214874-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214874-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214874-003	AB	1	`a72a2bbeb626…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214874-001	CGT	2024-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214874-001	CGT	2024-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214874-001	CGT	2024-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214874-001	CGT	2024-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214874-001	CGT	2024-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214874-001	CGT	2024-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214874-001	CGT	2024-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214874-001	CGT	2024-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214874-001	CGT	2024-04-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214874-001	CGT	2024-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214874-001	CGT	2024-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214874-001	CGT	2024-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214874-001	CGT	2024-04-15	`a72a2bbeb626…`

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: 2027-12-31

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
310490	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
6427db20-6783-439f-8c2d-64d1a6fcb9fc	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
82804-174-30	Glipizide	30 in 1 BOTTLE	TABLET	30		2
82804-174-90	Glipizide	90 in 1 BOTTLE	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-174-30	EA - Each	82804-174	3b61db3a-c01a-4e80-949e-5b7db3895f7b	1	2025-05-14
82804-174-90	EA - Each	82804-174	6c9574dc-7ab6-4842-a54a-1b198716a715	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-174	GLIPIZIDE TABLET [PROFICIENT RX LP]	2	Current NDC, 2 package rows	20250210_6427db20-6783-439f-8c2d-64d1a6fcb9fc.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	d9b6464f-6fe6-446e-8150-d0c15c46fee8	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	3de8b0a7-b848-40af-8406-fe6924ff41db	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals, Inc.	4c4dfe64-d1c5-65ec-e063-6394a90aead5	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	06fb6c56-5609-41d9-8389-eba81432218d	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	5ca7e38b-84cb-4043-b97e-e2f5cd82b442	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	c8cfd137-7b41-460f-a463-141c9d1985ff	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	A-S Medication Solutions	69a21bd3-3364-4035-b098-3808cc8cf8b2	2026-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	A-S Medication Solutions	c582d7d0-4db0-4296-8131-baefd1a671b2	2026-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	Advagen Pharma Limited	e954afb8-52eb-416a-8f1b-14b0fcb3bac2	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	A-S Medication Solutions	3b111484-78ef-4db9-95ee-6cc4b6acdd59	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	A-S Medication Solutions	155216cf-4bad-479a-83b6-032d4bd11c2e	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	Advanced Rx of Tennessee, LLC	3d87cc75-7a0d-46a2-e063-6294a90a6d49	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	4d490a3a-abdc-4ff4-83fb-f302f51e3023	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874
Glipizide	GLIPIZIDE	Proficient Rx LP	6427db20-6783-439f-8c2d-64d1a6fcb9fc	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874 ndc (package): 82804-174-90 ndc (product): 82804-174 ndc11 (package): 82804017490
Glipizide	GLIPIZIDE	TruPharma LLC	95ea4c96-84b9-4515-9494-a93d26820f70	2023-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214874 application number: ANDA214874

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
310490	glipiZIDE 5 MG Oral Tablet	PSN	6427db20-6783-439f-8c2d-64d1a6fcb9fc	2
310490	glipizide 5 MG Oral Tablet	SCD	6427db20-6783-439f-8c2d-64d1a6fcb9fc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-174-90	82804017490	90 TABLET in 1 BOTTLE (82804-174-90)	90 tablet	2025-01-20	No	No	Current