Glipizide

Product NDC: 68071-5326
11-digit product format: 680715326
Labeler code: 68071
Product ID: 68071-5326_5ce323e4-ea8d-22b5-e063-6294a90a15bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA074378
Marketing category: ANDA
Marketing start: 2025-05-01
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 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
A074378-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB		1994-11-28
A074378-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB		1994-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074378-001	AB
A074378-002	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	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1994-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1994-11-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1994-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1994-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1994-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1994-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1994-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1994-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1994-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1994-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074378-001	GLIPIZIDE	5MG	TABLET / ORAL		1994-11-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074378-002	GLIPIZIDE	10MG	TABLET / ORAL		1994-11-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074378-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074378-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074378-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074378-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074378-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074378-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074378-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074378-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074378-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074378-002	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074378-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074378-002	AB	1	`a50c72e98297…`

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	10 mg/1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	e0de2d19-b24b-46af-a10e-0b78c51350a4	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074378 application number: ANDA074378
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	9b405ff3-6ce5-460a-9406-db92e0e6ab1b	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074378 application number: ANDA074378
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	410bf280-838d-45af-9b60-15f94ded7581	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074378 application number: ANDA074378
Glipizide	GLIPIZIDE	Proficient Rx LP	f5d7a98c-d1d4-43b9-8d7e-830a33ae0c24	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074378 application number: ANDA074378

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	Exclude flag	Status
68071-5326-6	68071532606	60 TABLET in 1 BOTTLE (68071-5326-6)	60 tablet	2026-10-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLIPIZIDE TABLETS, USP 5 mg and 10 mg for oral use Rx only	NuCare Pharmaceuticals, Inc.	2026-10-02	HUMAN PRESCRIPTION DRUG LABEL	1