Application 079148

Type: ANDA
Sponsor: INDICUS 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
A079148-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25
A079148-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25
A079148-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25

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	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`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	A079148-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079148-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079148-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079148-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079148-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079148-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079148-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079148-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079148-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079148-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079148-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079148-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079148-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079148-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079148-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079148-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079148-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079148-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079148-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079148-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079148-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079148-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079148-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079148-003	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 9 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	Coupler, LLC	32ff33ed-89ed-c391-e063-6294a90ae414	2025-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	d7c1ff9e-4faa-4f65-9c87-e8108499791f	2025-03-28	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	3e55944a-ed5b-4892-804f-abbe15b0d70c	2025-03-28	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	de4a660b-172b-4c72-9e38-5634fd03cfa7	2025-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Coupler LLC	2d7d9364-e71d-4ef6-e063-6394a90af841	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	4db5551b-04f6-4921-9dee-68acb41f7f71	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0865f83f-0f34-0690-e063-6294a90abf04	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0b3d5420-d60c-8385-e063-6394a90abb6c	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Proficient Rx LP	f1530d4f-21d9-4a4f-a814-07b180828ecd	2025-02-01	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	7cb47c3e-6657-4c11-8aa2-ae172e5a8529	2025-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Lifsa Drugs, LLC	a2385bcd-0943-4411-8658-c22b50360385	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	RedPharm Drug, Inc.	fc61bafa-a506-14ae-e053-6394a90a9c7d	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	direct rx	a84cf1a3-3820-cd1b-e053-2995a90acf45	2025-01-22	Warnings	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4adeddf2-f449-4a61-9658-dfbff7c50230	2025-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride ER	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	27d6fdbc-27a8-c599-e063-6394a90a2233	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	0f251f2c-97f3-4048-84f2-81fea03685aa	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Oral Solution	METFORMIN HYDROCHLORIDE	TRUPHARMA, LLC	73691c6c-8841-4c5d-b4a5-c3ed3b5effa1	2024-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Oral Solution	METFORMIN HYDROCHLORIDE	Saptalis Pharmaceuticals, LLC.	df61d56e-18ff-404c-b671-42b39aa23574	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	286d959a-51cb-4dbd-a3e8-1ea2f00b54c7	2024-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	289dc8ec-42c8-1d09-e063-6394a90a97f0	2024-12-06	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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7626	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7627	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7628	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-253	Metformin hydrochloride	Metformin hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-255	Metformin hydrochloride	Metformin hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
24724-014	Metformin hydrochloride	Metformin hydrochloride	INDICUS PHARMA LLC	ANDA	Current
24724-014	Metformin hydrochloride	Metformin hydrochloride	INDICUS PHARMA LLC	ANDA	Current
24724-015	Metformin hydrochloride	Metformin hydrochloride	INDICUS PHARMA LLC	ANDA	Current
24724-015	Metformin hydrochloride	Metformin hydrochloride	INDICUS PHARMA LLC	ANDA	Current
24724-016	Metformin hydrochloride	Metformin hydrochloride	INDICUS PHARMA LLC	ANDA	Current
24724-016	Metformin hydrochloride	Metformin hydrochloride	INDICUS PHARMA LLC	ANDA	Current
43547-248	Metformin hydrochloride	Metformin hydrochloride	Solco healthcare U.S., LLC	ANDA	Current
43547-249	Metformin hydrochloride	Metformin hydrochloride	Solco healthcare U.S., LLC	ANDA	Current
43547-250	Metformin hydrochloride	Metformin hydrochloride	Solco healthcare U.S., LLC	ANDA	Current
63629-1396	Metformin hydrochloride	Metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1396	Metformin hydrochloride	Metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current