Application 090888

Type: ANDA
Sponsor: MARKSANS 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 42.

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
A090888-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12
A090888-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12
A090888-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090888-001	AB
A090888-002	AB
A090888-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090888-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2012-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090888-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2012-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090888-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2012-03-12	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090888-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090888-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090888-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090888-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090888-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090888-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090888-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090888-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090888-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090888-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090888-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090888-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090888-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090888-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090888-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090888-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090888-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090888-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090888-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090888-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090888-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090888-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090888-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090888-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090888-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090888-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090888-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090888-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090888-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090888-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090888-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090888-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090888-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090888-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090888-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090888-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090888-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090888-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090888-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090888-001	AB	1	`1e350fbaab3a…`

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 · 2 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	b8004451-7b26-425b-b5ea-cbb1b08e30e3	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090888 application number: ANDA090888 ndc (product): 25000-132 ndc (product): 25000-134 ndc (product): 25000-131
Metformin HCl	METFORMIN HCL	TIME CAP LABORATORIES, INC	542cec22-eeae-4704-9bb6-4176640e5ea8	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090888 application number: ANDA090888 ndc (product): 49483-621 ndc (product): 49483-620 ndc (product): 49483-622

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25000-131	Metformin Hydrochloride	Metformin Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-131	Metformin Hydrochloride	Metformin Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-132	Metformin Hydrochloride	Metformin Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-132	Metformin Hydrochloride	Metformin Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-134	Metformin Hydrochloride	Metformin Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-134	Metformin Hydrochloride	Metformin Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
43547-320	Metformin Hydrochloride	Metformin Hydrochloride	Solco healthcare U.S., LLC	ANDA	Current
43547-321	Metformin Hydrochloride	Metformin Hydrochloride	Solco healthcare U.S., LLC	ANDA	Current
43547-322	Metformin Hydrochloride	Metformin Hydrochloride	Solco healthcare U.S., LLC	ANDA	Current
49483-620	METFORMIN HCL	METFORMIN HCL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-620	METFORMIN HCL	METFORMIN HCL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-621	METFORMIN HCL	METFORMIN HCL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-621	METFORMIN HCL	METFORMIN HCL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-622	METFORMIN HCL	METFORMIN HCL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-622	METFORMIN HCL	METFORMIN HCL	TIME CAP LABORATORIES, INC	ANDA	Current