Glipizide

Product NDC: 68788-8138
Requested package NDC: 68788-8138-1
11-digit product format: 687888138
Labeler code: 68788
Product ID: 68788-8138_a2c8fccf-2431-4e3e-ba37-920df8ea189b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc..
Application: ANDA074223
Marketing category: ANDA
Marketing start: 2022-02-11
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 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
A074223-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB		1995-02-27
A074223-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB		1995-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074223-001	AB
A074223-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-02-27	`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	A074223-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074223-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074223-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074223-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074223-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074223-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074223-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074223-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074223-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074223-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074223-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074223-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074223-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074223-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074223-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074223-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074223-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074223-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074223-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074223-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074223-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074223-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074223-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074223-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074223-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074223-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074223-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074223-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074223-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074223-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074223-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074223-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074223-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074223-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074223-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074223-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074223-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074223-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074223-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074223-002	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
02857195-33e9-4c1f-9e5f-7cc62f283649	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
68788-8138-1	Glipizide	100 in 1 BOTTLE, PLASTIC	TABLET	100	5
68788-8138-3	Glipizide	30 in 1 BOTTLE, PLASTIC	TABLET	30	5
68788-8138-6	Glipizide	60 in 1 BOTTLE, PLASTIC	TABLET	60	5
68788-8138-8	Glipizide	180 in 1 BOTTLE, PLASTIC	TABLET	180	5
68788-8138-9	Glipizide	90 in 1 BOTTLE, PLASTIC	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8138-1	EA - Each	68788-8138	36e2282e-742e-40f9-9823-d59a77fd6afd	1	2022-03-09
68788-8138-3	EA - Each	68788-8138	18af44bd-7a9c-4082-a128-1c425f707340	1	2022-03-09
68788-8138-6	EA - Each	68788-8138	fa7628f1-0ec4-4537-9d81-c02ec9c22eb3	1	2022-03-09
68788-8138-8	EA - Each	68788-8138	12e28a42-cde5-4be6-9389-908cc0b00965	1	2022-03-09
68788-8138-9	EA - Each	68788-8138	7e157b82-8e1c-4e18-8099-080c868de7f7	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8138	GLIPIZIDE TABLET [PREFERRED PHARMACEUTICALS INC..]	3	Current NDC, Legacy NDC, 5 package rows	20240516_02857195-33e9-4c1f-9e5f-7cc62f283649.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc..	02857195-33e9-4c1f-9e5f-7cc62f283649	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223 ndc (package): 68788-8138-1 ndc (product): 68788-8138 ndc11 (package): 68788813801
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	65ddb8b3-19d4-482f-8aec-49dc167a4c40	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	A-S Medication Solutions	99af53db-e102-427a-a5a2-be1e69b3152d	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	3bb3b80a-30e8-62fe-e054-00144ff8d46c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	c829b7bf-1a12-44b2-b5ce-fd44a1f0d333	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	Proficient Rx LP	d5398166-5698-4ee5-bd41-3c24e4445b53	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	5c627a52-e4ca-7103-e053-2a91aa0ae13f	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	A-S Medication Solutions	b31ab6dd-0277-43ee-a054-f20c462f0c56	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	afb65cc1-a4fb-4771-b09c-dcf6e8c5786e	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	589dc76d-c347-0589-e053-2991aa0a2520	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	8c27962d-626b-30e6-e053-2a95a90a49c6	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	7c21db4d-6b9b-36c3-e053-2991aa0a0fd9	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	Actavis Pharma, Inc.	ad55dfd7-ffb5-478a-aa84-1009fa921e22	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	A-S Medication Solutions	0874340a-75a1-4ac9-b224-80c5c24e1b41	2023-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	bf5ff427-3ee4-4064-a55e-35daa2f12a06	2023-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	Aphena Pharma Solutions - Tennessee, LLC	d6c016f7-bf93-4322-a179-d4798234b381	2017-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223

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	02857195-33e9-4c1f-9e5f-7cc62f283649	5
310488	glipizide 10 MG Oral Tablet	SCD	02857195-33e9-4c1f-9e5f-7cc62f283649	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8138-1	68788813801	100 TABLET in 1 BOTTLE, PLASTIC (68788-8138-1)	100 tablet	2022-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
glipiZIDE Tablets, USP for oral use Rx only	Preferred Pharmaceuticals Inc..	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	5