Glipizide and Metformin Hydrochloride

Product NDC: 21695-894
11-digit product format: 216950894
Labeler code: 21695
Product ID: 21695-894_43fb007c-19bb-4a04-b47b-288a4f464c81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide and Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA077270
Marketing category: ANDA
Marketing start: 2010-03-12
Marketing end: 0000-00-00
Substance: GLIPIZIDE; METFORMIN HYDROCHLORIDE
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-894		I	Inactivated by FDA		2026-10-05
excluded package	package	21695-894	21695-894-00	I	Inactivated by FDA		2026-10-05

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	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	21695-894-00	`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	21695-894-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-894-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-894-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-894-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-894-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-894-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-894-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-894-00	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-894-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-894-00	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-894-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-894-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-894-00	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-894-00	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-894-00	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-894-00	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-894-00	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-894-00	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-894-00	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-894-00	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-894-00	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28
A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28
A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077270-001	AB
A077270-002	AB
A077270-003	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 4 · 129 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	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A077270-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077270-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077270-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077270-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077270-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077270-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077270-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077270-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077270-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077270-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077270-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077270-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077270-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077270-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077270-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077270-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09	Product name	2	20250625
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
b1de1ca9-d9db-4f4b-2103-09e2014d30d5	Product name	5	20180912
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-894-00	2019-09-24	C162847	48780-1	934fe258-4b90-48b1-e053-8cdaa90a720a	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLETS 7455 7456 7457 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-894-00	Glipizide and Metformin Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-894-00	EA - Each	21695-894	dd462ac2-17d9-4284-b6b8-f96261db235f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLIPIZIDE	ACTIVE INGREDIENT	X7WDT95N5C	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
GLIPIZIDE	ACTIVE MOIETY	X7WDT95N5C	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
METFORMIN	ACTIVE MOIETY	9100L32L2N	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-894	GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110414_43fb007c-19bb-4a04-b47b-288a4f464c81.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide and Metformin Hydrochloride	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	03d9ce02-0559-494c-a53d-de9b9a64b606	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077270 application number: ANDA077270
Glipizide and Metformin Hydrochloride	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	AvKARE	13be49d2-0ce9-a78a-e557-ded85ddc808f	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077270 application number: ANDA077270

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X7WDT95N5C	GLIPIZIDE	29094-61-9	GLIPIZIDE
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861740	glipiZIDE 5 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	43fb007c-19bb-4a04-b47b-288a4f464c81	1
861740	glipizide 5 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	43fb007c-19bb-4a04-b47b-288a4f464c81	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-894-00	21695089400	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLETS 7455 7456 7457 Rx only	Rebel Distributors Corp	2011-04-13	HUMAN PRESCRIPTION DRUG LABEL	1