Metformin Hydrochloride

Product NDC: 43353-096
11-digit product format: 433530096
Labeler code: 43353
Product ID: 43353-096_ed6d6ba2-96b7-4149-a6b8-85fe75f6f95a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA203769
Marketing category: ANDA
Marketing start: 2014-02-01
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 1000 mg/1
Pharmacologic classes: Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43353-096		D	Discontinued by firm		2026-08-11
excluded package	package	43353-096	43353-096-80	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-096-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-096-80	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203769-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11
A203769-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11
A203769-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11
A203769-004	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2026-02-09
A203769-005	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2026-02-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A203769-001	AB
A203769-002	AB
A203769-003	AB
A203769-004	AB
A203769-005	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 · 127 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	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-004	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2026-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-005	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2026-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 127 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	A203769-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203769-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203769-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203769-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203769-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203769-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203769-002	AB	1	`1e350fbaab3a…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-096	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20160712_11c049a8-a209-414f-b67c-081b6f350014.zip

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	13235d8e-ac3a-45b4-9c5d-9a9012951dfe	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	836f3647-bfef-40d1-b475-c0d240241a67	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	388ee1e0-a0d2-324d-e063-6394a90a1664	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	direct rx	c33e24e9-0441-6b94-e053-2a95a90a9c68	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Method Pharmaceuticals, LLC.	4aa880a4-7ec0-9155-e063-6394a90a8f3e	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc	dfac4d9c-2f20-417c-a1be-4f1c2738f351	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	273d86b0-9d30-48c9-8918-c5e1ececa951	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	72dbc087-9a84-4126-bf54-c5254a8b129c	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3982b985-9184-0e17-e063-6394a90aae05	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3890b116-7c3c-e48e-e063-6294a90a0c8a	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	ec3a9070-3745-41fb-b610-8d06129d8fd9	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	51e1fe6e-a7fa-47a5-bbd5-73b275230c7f	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	32d6c5f4-0116-4e38-b179-e1967ae63e66	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	4670d280-53c3-4c51-b3c5-26d71e47bddc	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	928ef685-80cb-42a9-a155-3c21c9b1dd67	2024-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	9c33414b-5dbb-4ce9-910b-9480d45e50ee	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	f9e78e0f-6a0a-4db3-bc09-5500748f9c84	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	88af3365-1145-45a1-ab0f-1c794f0c13db	2023-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	8ce6b615-2abd-4a5b-997b-11aa1aec142d	2023-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	f86bda10-8b25-4125-8bb1-1b5917969ff0	2023-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-096-80	43353009680	180 TABLET, FILM COATED in 1 BOTTLE (43353-096-80)	2015-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE TABLETS USP	Aphena Pharma Solutions - Tennessee, LLC	2016-06-28	HUMAN PRESCRIPTION DRUG LABEL	1