glipizide and metformin hcl

Product NDC: 70518-1594
11-digit product format: 705181594
Labeler code: 70518
Product ID: 70518-1594_c07ba8a3-cd0a-6072-e053-2a95a90ab319
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glipizide and metformin hcl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078728
Marketing category: ANDA
Marketing start: 2018-10-26
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-1594		D	Discontinued by firm	2026-08-03
excluded package	package	70518-1594	70518-1594-0	D	Discontinued by firm	2026-08-03
excluded package	package	70518-1594	70518-1594-1	D	Discontinued by firm	2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23
A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23
A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078728-001	AB
A078728-002	AB
A078728-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2010-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2010-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078728-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2010-06-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A078728-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078728-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078728-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078728-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078728-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078728-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078728-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078728-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078728-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078728-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078728-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078728-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078728-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078728-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078728-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078728-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078728-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078728-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078728-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078728-001	AB	1	`8072bd15b7f6…`

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1594	GLIPIZIDE AND METFORMIN HCL TABLET, FILM COATED [REMEDYREPACK INC.]	11	Legacy NDC	20250523_b64517f9-f3b7-4254-9713-e68a4d98da90.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide and Metformin HCl	GLIPIZIDE AND METFORMIN HCL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	94a7f96e-2ed1-432d-bc6a-5840863816e1	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078728 application number: ANDA078728
Glipizide and metformin hcl	GLIPIZIDE AND METFORMIN HCL	Chartwell RX, LLC	ac018f64-fd9d-4b3c-b0ac-ca305b8df635	2025-12-10	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 078728 application number: ANDA078728
Glipizide and Metformin HCl	GLIPIZIDE AND METFORMIN HCL	Proficient Rx LP	be4d2552-c964-4d09-ba7a-0d94320f968c	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078728 application number: ANDA078728

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
70518-1594-0	70518159400	180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1594-0)	2018-10-26	0000-00-00	No	No	Current
70518-1594-1	70518159401	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1594-1)	2019-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glipizide and Metformin HCl Tablets USP 2.5 mg/250 mg 2.5 mg/500 mg 5 mg/500 mg Rx Only	REMEDYREPACK INC.	2026-01-26	HUMAN PRESCRIPTION DRUG LABEL	13