Application 075978

Type: ANDA
Sponsor: HERITAGE PHARMA

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
A075978-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25
A075978-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25
A075978-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075978-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075978-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075978-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075978-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075978-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075978-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075978-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075978-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075978-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075978-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075978-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075978-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075978-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075978-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075978-003	AB	1	`ea99ee380514…`

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 14 of 14 · 261 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Metcure Pharmaceuticals, Inc.	5df6adc9-79fd-66ef-e053-2991aa0a75ce	2018-01-22	Boxed warning, 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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1048	Metformin Hydrochloride	Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1049	Metformin Hydrochloride	Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7214	Metformin Hydrochloride	Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0615-7661	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7662	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7663	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-058	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-067	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-068	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
48433-326	Metformin Hydrochloride	Metformin Hydrochloride	Safecor Health, LLC	ANDA	Current
63629-6794	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
66116-370	Metformin Hydrochloride	Metformin Hydrochloride	MedVantx, Inc.	ANDA	Current
66116-378	Metformin Hydrochloride	Metformin Hydrochloride	MedVantx, Inc.	ANDA	Current
68071-3226	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current