Application 091184

Type: ANDA
Sponsor: ALKEM

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 1.

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	TE codes	Approval date
A091184-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01
A091184-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01
A091184-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091184-001	AB
A091184-002	AB
A091184-003	AB

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 · 123 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
2026-02-19 14:30 UTC	2026-02	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091184-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091184-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091184-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091184-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091184-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091184-001	AB	1	`8072bd15b7f6…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	0ff1ba75-3c86-4baf-a6b1-1bb883839866	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091184 application number: ANDA091184 ndc (product): 67877-218 ndc (product): 67877-221 ndc (product): 67877-217

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-5739	Metformin Hydrochloride	Metformin Hydrochloride	Liberty Pharmaceuticals, Inc.	ANDA	Current
0440-5745	Metformin Hydrochloride	Metformin Hydrochloride	Liberty Pharmaceuticals, Inc.	ANDA	Current
0440-5746	Metformin Hydrochloride	Metformin Hydrochloride	Liberty Pharmaceuticals, Inc.	ANDA	Current
0904-6326	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6327	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6328	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
12634-756	Metformin Hydrochloride	Metformin Hydrochloride	Apotheca Inc.	ANDA	Current
12634-757	Metformin Hydrochloride	Metformin Hydrochloride	Apotheca Inc.	ANDA	Current
12634-789	Metformin Hydrochloride	Metformin Hydrochloride	Apotheca Inc.	ANDA	Current
42708-117	Metformin Hydrochloride	Metformin Hydrochloride	QPharma Inc	ANDA	Current
42708-117	Metformin Hydrochloride	Metformin Hydrochloride	QPharma Inc	ANDA	Current
43353-128	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-2410	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2612	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2635	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3088	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
53808-1033	Metformin Hydrochloride	Metformin Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5888	Metformin Hydrochloride	Metformin Hydrochloride	Cardinal Health	ANDA	Current
55154-5888	Metformin Hydrochloride	Metformin Hydrochloride	Cardinal Health	ANDA	Current
55700-475	Metformin Hydrochloride	Metformin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
67877-217	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-217	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-217	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-218	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-218	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-218	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-221	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-221	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-221	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
68788-6982	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6982	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6982	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7069	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7069	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7069	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0672	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70882-125	Metformin Hydrochloride	Metformin Hydrochloride	Cambridge Therapeutics Technologies, LLC	ANDA	Current