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 3 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	MARKSANS PHARMA LIMITED	d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE TABLET	Granules India Ltd	8cd5555c-f6b2-28d8-e053-2a95a90a5f1e	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	552ad61d-bafd-478d-e063-6294a90a02f9	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	3d6f397b-e909-bee9-e063-6294a90aba17	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Viona Pharmaceuticals Inc	85027e6c-d35b-49eb-a234-dd71aa77aee0	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS	AiPing Pharmaceutical, Inc.	96c8a89d-99db-24b1-e053-2a95a90ac2b8	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	41a8bb80-7b0b-476c-8134-5d161c3239c8	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	8d4b8620-5e99-4d12-b4f2-e9967b627b57	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Major Pharmaceuticals	5e783025-bf6d-465e-bf58-bcd253afad2c	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4182bcf0-1f9a-4f3a-9428-86b5d757954f	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c3	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	14450912-54b5-4fc3-ba65-77ece864b2e7	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	902d1bc4-3f1f-4a1a-86d7-cf98c56a3684	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	33550b88-d4bb-4ce6-a7db-07c966f6984f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	14238afd-200d-4a05-b731-647c43cecbc3	2026-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	104b5f5b-cc83-450d-82ec-1fd20c4f7119	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	11d52559-bfde-4c2a-9602-f18fb3187617	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN	Mylan Pharmaceuticals Inc.	7e41818c-60e9-4bcf-9586-7bb8d33d5e89	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f4fc759a-057e-4b5d-b8ab-13bc5eeb24e4	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	400ff9dc-9789-44ac-afb5-730b632a1667	2026-06-12	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