Application 078170

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	850MG	No	No
003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	1GM	No	No

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	Approval date
A078170-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-05-23
A078170-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-05-23
A078170-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-05-23

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	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2008-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2008-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2008-05-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2008-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2008-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2008-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2008-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2008-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2008-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2008-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2008-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2008-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2008-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2008-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2008-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2008-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2008-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2008-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2008-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2008-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2008-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2008-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2008-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2008-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2008-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2008-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2008-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2008-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2008-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2008-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2008-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2008-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2008-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2008-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2008-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2008-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2008-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078170-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2008-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078170-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2008-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078170-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2008-05-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A078170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078170-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078170-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078170-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078170-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078170-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078170-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078170-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078170-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078170-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078170-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078170-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078170-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078170-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078170-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078170-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078170-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078170-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078170-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078170-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078170-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078170-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078170-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078170-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078170-001	AB	1	`5d02ea3f76ae…`

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 11 of 14 · 261 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4a53ea53-3052-614b-e054-00144ff8d46c	2024-07-19	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Granules Pharmaceuticals Inc.	a5980bc8-8de8-c456-e053-2a95a90a792e	2024-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1ef6c527-89f5-4830-8900-7532b0a7ef26	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Epic Pharma, LLC	a9e7608f-540c-d90c-e053-2a95a90a4f98	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1a047fc0-196e-79af-e063-6394a90a1e0d	2024-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1c046303-993c-4111-ac9a-40a0d97ca6a2	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f6	2024-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	afb183f6-a13c-4f00-82d5-9fe336173d34	2024-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	d5dbf0d9-9673-4aae-9e28-da9b90bac038	2024-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c2783b59-7b20-4d4c-a3ca-03ed60dcf2c3	2024-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2be73d5e-7682-4ad3-831b-8c1ea73e38de	2024-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	928ef685-80cb-42a9-a155-3c21c9b1dd67	2024-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1182bf60-3578-a0ed-e063-6394a90aa50f	2024-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	9c33414b-5dbb-4ce9-910b-9480d45e50ee	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	f9e78e0f-6a0a-4db3-bc09-5500748f9c84	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	3c607f04-d36f-4cf8-9cc9-7f2af08b4098	2024-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	7cc82387-8bb0-4bee-9967-cb13eab1d801	2024-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	b090b18b-b53c-4c92-892f-d11551cfedc3	2023-12-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	38687872-ca68-4965-b317-637c25ba041e	2023-11-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	d0bc43a4-301f-4002-9b58-bd81dddf2790	2023-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-0381	Metformin Hydrochloride	Metformin Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0712	Metformin Hydrochloride	Metformin Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0717	Metformin Hydrochloride	Metformin Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
68462-159	Metformin Hydrochloride	Metformin Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-160	Metformin Hydrochloride	Metformin Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-161	Metformin Hydrochloride	Metformin Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current