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 2 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	PD-Rx Pharmaceuticals, Inc.	1d0b74de-ef4c-4dd2-8019-2ddb409c60b4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	59a4ccda-5487-4ac4-9373-0c0fc8b7c88b	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f55a245b-a786-4a4a-b11c-c61d48294b01	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	41408f64-d366-403e-9595-464ab25c6f97	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68d0b1a6-c99e-42cf-afdf-b71ee73c4424	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9171d369-d35a-40e4-a9ad-26484e66fc5e	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	30658e19-8e6e-49aa-a007-e414224797c5	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1503bbe4-0ac5-479b-9900-d38e49236bf0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Cardinal Health 107, LLC	46cb7e3f-c739-433d-9dbe-427c2d95bef1	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Chartwell RX, LLC	4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	13235d8e-ac3a-45b4-9c5d-9a9012951dfe	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c82a10fa-1e8e-46b6-890a-737de3f34ee1	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5aa1c86c-f2c8-49b1-8f81-47b11386c5d3	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	4ac6d01a-af26-44e7-ae2e-3618de0080aa	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	5647230e-5bc6-1802-e063-6394a90a2724	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	fc466c46-abaa-4675-aef2-4b1a1adfd912	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	14f3091c-f243-4364-b433-727c7d4ef8d5	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	17050df5-9e95-4e1b-ac75-34add289b139	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Amneal Pharmaceuticals LLC	dc65065b-cba0-46d7-8fb5-3368f3210b4d	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	9eebed09-2562-4d21-b3b3-c06562fe3f99	2026-07-01	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