Glipizide

Product NDC: 53002-4462
11-digit product format: 530024462
Labeler code: 53002
Product ID: 53002-4462_eeb762f9-917d-4697-b650-1371ada361e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA075795
Marketing category: ANDA
Marketing start: 2002-09-25
Marketing end: 0000-00-00
Substance: GLIPIZIDE
Active strength: 5 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-4462		I	Inactivated by FDA	2026-08-07
excluded package	package	53002-4462	53002-4462-0	I	Inactivated by FDA	2026-08-07
excluded package	package	53002-4462	53002-4462-3	I	Inactivated by FDA	2026-08-07
excluded package	package	53002-4462	53002-4462-6	I	Inactivated by FDA	2026-08-07

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-4462-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-4462-0	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-4462-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-4462-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-4462-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-4462-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-4462-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-4462-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-4462-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-4462-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-4462-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-4462-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-4462-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-4462-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-4462-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-4462-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-4462-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-4462-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-4462-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-4462-0	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-4462-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-4462-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-4462-0	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-4462-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-4462-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-4462-0	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-4462-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-4462-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-4462-0	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-4462-6	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-4462-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-4462-0	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-4462-6	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A075795-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13
A075795-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075795-001	AB
A075795-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		2001-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		2001-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		2001-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		2001-06-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		2001-06-13	`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	A075795-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075795-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075795-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075795-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075795-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075795-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075795-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075795-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075795-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075795-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075795-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075795-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075795-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075795-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075795-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075795-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075795-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075795-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075795-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075795-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075795-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075795-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075795-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075795-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075795-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075795-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075795-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075795-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075795-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075795-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075795-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075795-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075795-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075795-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075795-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075795-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075795-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075795-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075795-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075795-002	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-4462-0	2025-01-30	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-3	2025-01-30	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-6	2025-01-30	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-0	2023-06-07	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-3	2023-06-07	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-6	2023-06-07	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-0	2020-12-17	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-3	2020-12-17	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-6	2020-12-17	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-0	2020-01-31	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-3	2020-01-31	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
53002-4462-6	2020-01-31	GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-4462-0	Glipizide	100 in 1 BOTTLE	TABLET	100	8
53002-4462-3	Glipizide	30 in 1 BOTTLE	TABLET	30	8
53002-4462-6	Glipizide	60 in 1 BOTTLE	TABLET	60	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-4462	GLIPIZIDE TABLET [RPK PHARMACEUTICALS, INC.]	8	Legacy NDC, 3 package rows	20230609_fdccb7bd-6eb5-4bc2-b4f5-b49608df479f.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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	376ce3cf-4e1b-4b5f-b3e7-cc9fc4a5aeb4	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	212897cb-7de7-4711-aaf4-44234f950e9f	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	American Health Packaging	ff6805bb-b5f0-46d3-bf1d-3333b63ff1ae	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Coupler LLC	53e650f1-f755-e3ad-e063-6294a90ae309	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Coupler LLC	51b35391-7672-c02f-e063-6294a90af54e	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Cardinal Health 107, LLC	bf1f5a5d-79b0-4fc5-96f2-bd5119b56e2a	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals, Inc.	097424ef-612f-4bc2-809a-e5bb8eeae244	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Major Pharmaceuticals	d3b5677c-2265-47c8-beeb-bf12106056ba	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Legacy Pharmaceutical Packaging, LLC	116ffc6a-735c-49e0-a9d5-69b6bc3e3706	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	9c9a3688-6de9-41db-af82-c4aa9b5b3f92	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	f60b0690-aca9-40ec-956e-bd2ecc35ec54	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	383540fd-2931-49bf-8009-25e8f7fc9bda	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	a38cfe61-4aa5-498c-bca5-03a8213303bb	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0ed5ed22-dd53-495d-bc10-0bede4d87926	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	6282c653-9e9c-6810-e053-2991aa0a4a8e	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	AvPAK	aa1b16bf-e01c-d539-e053-2995a90a2735	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	c16edad6-4271-6ff0-e053-2a95a90a0240	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	16fb8bc7-1db1-477e-a201-b3b678b8a84c	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	1b2e5656-9da9-4fab-bf01-ed75896b836a	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Apotex Corp.	dcf426b8-bcdc-8214-a1b6-6388bd3399a0	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795

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	fdccb7bd-6eb5-4bc2-b4f5-b49608df479f	8
310490	glipiZIDE 5 MG Oral Tablet	PSN	fdccb7bd-6eb5-4bc2-b4f5-b49608df479f	8
310488	glipizide 10 MG Oral Tablet	SCD	fdccb7bd-6eb5-4bc2-b4f5-b49608df479f	8
310490	glipizide 5 MG Oral Tablet	SCD	fdccb7bd-6eb5-4bc2-b4f5-b49608df479f	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-4462-0	53002446200	100 TABLET in 1 BOTTLE (53002-4462-0)	100 tablet	2018-10-01	0000-00-00	No	No	Current
53002-4462-3	53002446203	30 TABLET in 1 BOTTLE (53002-4462-3)	30 tablet	2018-10-01	0000-00-00	No	No	Current
53002-4462-6	53002446206	60 TABLET in 1 BOTTLE (53002-4462-6)	60 tablet	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	8