Glipizide

Product NDC: 67544-097
11-digit product format: 675440097
Labeler code: 67544
Product ID: 67544-097_4458c829-ec73-4861-9ff6-3839cdc60643
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA074305
Marketing category: ANDA
Marketing start: 1995-04-07
Marketing end: 0000-00-00
Substance: GLIPIZIDE
Active strength: 10 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-097		D	Discontinued by firm	2026-10-23
excluded package	package	67544-097	67544-097-53	D	Discontinued by firm	2026-10-23
excluded package	package	67544-097	67544-097-60	D	Discontinued by firm	2026-10-23
excluded package	package	67544-097	67544-097-70	D	Discontinued by firm	2026-10-23
excluded package	package	67544-097	67544-097-80	D	Discontinued by firm	2026-10-23
excluded package	package	67544-097	67544-097-92	D	Discontinued by firm	2026-10-23
excluded package	package	67544-097	67544-097-94	D	Discontinued by firm	2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-097-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-097-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-097-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-097-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-097-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-097-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-097-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-097-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-097-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-097-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-097-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-097-80	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074305-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07
A074305-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07
A074305-003	GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET / ORAL	AB	2026-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074305-001	AB
A074305-002	AB
A074305-003	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 3 · 89 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
2026-10-15 13:18:30	2026-09	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074305-003	GLIPIZIDE	2.5MG	TABLET / ORAL	AB	2026-09-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL		1995-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL		1995-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074305-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1995-04-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074305-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1995-04-07	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A074305-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074305-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074305-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074305-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074305-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074305-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074305-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074305-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074305-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074305-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074305-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074305-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074305-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074305-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074305-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074305-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074305-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074305-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A074305-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074305-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A074305-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074305-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074305-002	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-097-53	EA - Each	67544-097	ed217f0a-b4c3-426a-8857-cd9928dd5be3	1	2013-06-04
67544-097-60	EA - Each	67544-097	cdcc40b6-e437-47fb-9951-3c9e1915d3b4	1	2013-06-04
67544-097-70	EA - Each	67544-097	2f3007b4-8e4a-4ab0-bb02-d9681040b3c5	1	2013-06-04
67544-097-80	EA - Each	67544-097	3eb492d3-10fa-43e7-8925-20190c7b4388	1	2013-06-04
67544-097-92	EA - Each	67544-097	0897863a-132b-4000-ae17-aaf54031d6e1	1	2014-07-02
67544-097-94	EA - Each	67544-097	e07cb483-8ff1-4e2f-88a2-0ad25577d5e2	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLIPIZIDE	ACTIVE INGREDIENT	X7WDT95N5C	GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
GLIPIZIDE	ACTIVE MOIETY	X7WDT95N5C	GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-097	GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC	20171018_4293c145-9fec-4c4f-b71e-1594ae106321.zip

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	Marketing end	Sample	Exclude flag	Status
67544-097-53	67544009753	60 TABLET in 1 BOTTLE, PLASTIC (67544-097-53)	60 tablet	2010-02-23	0000-00-00	No	No	Current
67544-097-60	67544009760	90 TABLET in 1 BOTTLE, PLASTIC (67544-097-60)	90 tablet	2006-12-22	0000-00-00	No	No	Current
67544-097-70	67544009770	120 TABLET in 1 BOTTLE, PLASTIC (67544-097-70)	120 tablet	2010-02-23	0000-00-00	No	No	Current
67544-097-80	67544009780	180 TABLET in 1 BOTTLE, PLASTIC (67544-097-80)	180 tablet	2008-04-25	0000-00-00	No	No	Current
67544-097-92	67544009792	270 TABLET in 1 BOTTLE, PLASTIC (67544-097-92)	270 tablet	2010-02-23	0000-00-00	No	No	Current
67544-097-94	67544009794	360 TABLET in 1 BOTTLE, PLASTIC (67544-097-94)	360 tablet	2010-02-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GlipiZIDE Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2017-09-15	HUMAN PRESCRIPTION DRUG LABEL	3