Metformin Hydrochloride

Product NDC: 51224-120
11-digit product format: 512240120
Labeler code: 51224
Product ID: 51224-120_62d835b1-e8f8-439a-bfb1-d42a18c431bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: TAGI Pharma, Inc.
Application: ANDA205096
Marketing category: ANDA
Marketing start: 2019-05-01
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 850 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51224-120		D	Discontinued by firm	2026-08-03
excluded package	package	51224-120	51224-120-50	D	Discontinued by firm	2026-08-03
excluded package	package	51224-120	51224-120-60	D	Discontinued by firm	2026-08-03
excluded package	package	51224-120	51224-120-70	D	Discontinued by firm	2026-08-03

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 · 6 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	51224-120-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51224-120-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51224-120-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51224-120-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51224-120-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A205096-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11
A205096-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11
A205096-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205096-001	AB
A205096-002	AB
A205096-003	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	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`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	A205096-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205096-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205096-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205096-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51224-120-50	EA - Each	51224-120	f3436f91-d596-418d-b3a9-8e678ad89b50	1	2019-08-06
51224-120-60	EA - Each	51224-120	43f131c1-a042-40af-9430-733a9b10e636	1	2019-08-06
51224-120-70	EA - Each	51224-120	798b54ff-ef4a-47f8-801f-9af516dc3a49	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51224-120	METFORMIN HYDROCHLORIDE TABLET, COATED [TAGI PHARMA, INC.]	1	Legacy NDC	20190501_9e8686e9-cc6e-41a5-8709-215a6670575a.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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4d4021ba-4b28-6b81-e063-6294a90a5ea7	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	37ff1b8e-a434-41c0-82e1-4583842921a5	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Mullan Pharmaceutical Inc.	082b4de9-e452-fe71-e063-6394a90ac863	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f6581ce6-0f9f-4887-ae83-4c6ecde619f3	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler, LLC	32ff33ed-89ed-c391-e063-6294a90ae414	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	565610b8-a9a0-4e5e-866d-81d9501a817d	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2d2ebf52-3d5e-4fad-b7f7-c9280957574c	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c2bbaa0c-5b05-4335-882f-14f1b443edd7	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	54ca16e6-1213-4877-8ace-477c764c8e76	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	583dac53-65e7-4710-912a-ecd89d07ad03	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096

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
51224-120-50	51224012050	100 TABLET, COATED in 1 BOTTLE (51224-120-50)	2019-05-01	0000-00-00	No	No	Current
51224-120-60	51224012060	500 TABLET, COATED in 1 BOTTLE (51224-120-60)	2019-05-01	0000-00-00	No	No	Current
51224-120-70	51224012070	1000 TABLET, COATED in 1 BOTTLE (51224-120-70)	2019-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride	TAGI Pharma, Inc. \| CSPC Ouyi Pharmaceutical Co., Ltd	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	3
Metformin Hydrochloride	Bryant Ranch Prepack	2024-09-27	HUMAN PRESCRIPTION DRUG LABEL	6