Glipizide and Metformin Hydrochloride

Product NDC: 71335-1778
Requested package NDC: 71335-1778-3
11-digit product format: 713351778
Labeler code: 71335
Product ID: 71335-1778_a9b480a1-42e4-424b-9563-27c01f06b7c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide and Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078905
Marketing category: ANDA
Marketing start: 2016-05-05
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: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-1778	71335-1778-3	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31
A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31
A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078905-001	AB
A078905-002	AB
A078905-003	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`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	A078905-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078905-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078905-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078905-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078905-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078905-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078905-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078905-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078905-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078905-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078905-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078905-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078905-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078905-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078905-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078905-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

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 · 3 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	Zydus Pharmaceuticals USA Inc.	1b18b903-eb52-4d08-b4a5-f984957eb116	2026-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078905 application number: ANDA078905
Glipizide and Metformin Hydrochloride	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	A-S Medication Solutions	4a2d814b-93a1-4487-b789-dbafe9f0ffd3	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078905 application number: ANDA078905
Glipizide and Metformin Hydrochloride	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	bd2e1c06-424b-4222-b723-90ffdcc3983c	2024-11-30		Exact identifier application applno (ANDA): 078905 application number: ANDA078905

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1778-3	71335177803	90 TABLET, FILM COATED in 1 BOTTLE (71335-1778-3)	2021-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glipizide and Metformin Hydrochloride Tablets, USP	Bryant Ranch Prepack	2021-03-11	HUMAN PRESCRIPTION DRUG LABEL	100