Metformin Hydrochloride

Product NDC: 51224-007
11-digit product format: 512240007
Labeler code: 51224
Product ID: 51224-007_edb2d11c-e64f-4f34-9f13-98b4f9a834a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: TAGI Pharma, Inc.
Application: ANDA078321
Marketing category: ANDA
Marketing start: 2008-04-17
Marketing end: 2026-10-31
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Current FDA listing: Yes

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.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	51224-007-50
excluded package	package	51224-007-70
excluded package	package	51224-007-60

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078321-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-04-17
A078321-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078321-001	AB1
A078321-002	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 3 · 82 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	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078321-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078321-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078321-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078321-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078321-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078321-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078321-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078321-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078321-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078321-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078321-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078321-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078321-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078321-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078321-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078321-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078321-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078321-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metformin Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
786Z46389E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860975	Internal RxNorm lookup
860981	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dd0ee2bf-f658-42dc-976d-49af0b1f32b5	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51224-007-50	Metformin Hydrochloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	9
51224-007-60	Metformin Hydrochloride	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	9
51224-007-70	Metformin Hydrochloride	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51224-007-50	EA - Each	51224-007	f8e98f10-0d52-48bf-8bca-a91faaafa9be	1	2016-07-19
51224-007-60	EA - Each	51224-007	9a881fef-67f9-49b5-9558-25db0baf208e	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51224-007	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [TAGI PHARMA, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20250424_dd0ee2bf-f658-42dc-976d-49af0b1f32b5.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 · 21 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.	41408f64-d366-403e-9595-464ab25c6f97	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68d0b1a6-c99e-42cf-afdf-b71ee73c4424	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1503bbe4-0ac5-479b-9900-d38e49236bf0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	4d245bc3-0add-4651-b441-86b93c5ac681	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	60142fb2-16da-4f54-a542-74f9a70b9c8b	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1d0b74de-ef4c-4dd2-8019-2ddb409c60b4	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	AvPAK	d9bac244-1725-5bf3-e053-2a95a90ac823	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	AvPAK	de09f7a1-1e9f-60f4-e053-2a95a90a93d8	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	ab80521b-5014-cc2a-e053-2a95a90a2003	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	c568d49f-c040-4f1e-ad36-77b05ab659c3	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	bf918d78-3fb6-4d8d-b42d-538ea10bc3e4	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e55ee270-5eb9-4848-8529-9af2a79669c0	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	TAGI Pharma, Inc.	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	2025-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 51224-007
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	de4a660b-172b-4c72-9e38-5634fd03cfa7	2025-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	7cb47c3e-6657-4c11-8aa2-ae172e5a8529	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	RedPharm Drug, Inc.	fc61bafa-a506-14ae-e053-6394a90a9c7d	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	direct rx	a84cf1a3-3820-cd1b-e053-2995a90acf45	2025-01-22	Warnings	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride Extended-Release 500mg	METFORMIN HYDROCHLORIDE	Calvin Scott & Co., Inc.	e9cd0d23-56eb-40dd-abf4-9e681ec220f5	2023-02-07	Warnings	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	d80aa4af-a8ce-4cae-b71c-05e1de829551	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4d89a4ab-6cdd-4c39-92f9-a137fa27a070	2021-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	de4a660b-172b-4c72-9e38-5634fd03cfa7	10
860981	metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet	PSN	de4a660b-172b-4c72-9e38-5634fd03cfa7	10
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	de4a660b-172b-4c72-9e38-5634fd03cfa7	10
860981	24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet	SCD	de4a660b-172b-4c72-9e38-5634fd03cfa7	10
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	de4a660b-172b-4c72-9e38-5634fd03cfa7	10
860981	metformin HCl 750 MG 24 HR Extended Release Oral Tablet	SY	de4a660b-172b-4c72-9e38-5634fd03cfa7	10
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	9
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	96b40564-d7d6-655b-e053-2a95a90a1f95	9
860981	metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet	PSN	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	9
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	9
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	96b40564-d7d6-655b-e053-2a95a90a1f95	9
860981	24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet	SCD	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	9
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	9
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	96b40564-d7d6-655b-e053-2a95a90a1f95	9
860981	metformin HCl 750 MG 24 HR Extended Release Oral Tablet	SY	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	9
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	a84cf1a3-3820-cd1b-e053-2995a90acf45	8
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	a84cf1a3-3820-cd1b-e053-2995a90acf45	8
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	a84cf1a3-3820-cd1b-e053-2995a90acf45	8
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	14607665-093a-4f10-b1e6-f618e380408e	5
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	70a765db-7cf2-2958-e053-2991aa0adcb5	5
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	70a765db-7cf2-2958-e053-2991aa0adcb5	5
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	14607665-093a-4f10-b1e6-f618e380408e	5
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	70a765db-7cf2-2958-e053-2991aa0adcb5	5
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	14607665-093a-4f10-b1e6-f618e380408e	5
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	d80aa4af-a8ce-4cae-b71c-05e1de829551	4
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	d80aa4af-a8ce-4cae-b71c-05e1de829551	4
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	d80aa4af-a8ce-4cae-b71c-05e1de829551	4
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	a9dd42c0-8f4a-4254-a1bd-9c298060cb98	2
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	4d89a4ab-6cdd-4c39-92f9-a137fa27a070	2
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	fc61bafa-a506-14ae-e053-6394a90a9c7d	2
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	a9dd42c0-8f4a-4254-a1bd-9c298060cb98	2
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	4d89a4ab-6cdd-4c39-92f9-a137fa27a070	2
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	fc61bafa-a506-14ae-e053-6394a90a9c7d	2
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	a9dd42c0-8f4a-4254-a1bd-9c298060cb98	2
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	4d89a4ab-6cdd-4c39-92f9-a137fa27a070	2
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	fc61bafa-a506-14ae-e053-6394a90a9c7d	2
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	ceb4546d-2576-4b26-a5e5-120744f3c3dd	1
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	e9cd0d23-56eb-40dd-abf4-9e681ec220f5	1
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	ceb4546d-2576-4b26-a5e5-120744f3c3dd	1
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	e9cd0d23-56eb-40dd-abf4-9e681ec220f5	1
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	ceb4546d-2576-4b26-a5e5-120744f3c3dd	1
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	e9cd0d23-56eb-40dd-abf4-9e681ec220f5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51224-007-50	51224000750	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-007-50)	2016-06-01	2026-10-31	No	No	Current
51224-007-60	51224000760	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-007-60)	2016-06-01	2026-10-31	No	No	Current
51224-007-70	51224000770	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-007-70)	2019-01-01	2026-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride	TAGI Pharma, Inc. \| CSPC Ouyi Pharmaceutical Co., Ltd	2025-04-18	HUMAN PRESCRIPTION DRUG LABEL	9
Metformin Hydrochloride	Bryant Ranch Prepack	2025-03-10	HUMAN PRESCRIPTION DRUG LABEL	10
Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	18
Metformin ER 50mg	RedPharm Drug, Inc. \| Redpharm Drug	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	2
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	direct rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	8
Metformin Hydrochloride	REMEDYREPACK INC.	2025-01-10	HUMAN PRESCRIPTION DRUG LABEL	15
Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	2023-07-27	HUMAN PRESCRIPTION DRUG LABEL	6
Metformin Hydrochloride Extended-Release Tablets 500mg	Calvin Scott & Co., Inc.	2023-02-07	HUMAN PRESCRIPTION DRUG LABEL	1
Metformin Hydrochloride	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride	Bryant Ranch Prepack	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	2
Metformin Hydrochloride	Quality Care Products, LLC	2021-11-17	HUMAN PRESCRIPTION DRUG LABEL	5
Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2021-07-02	HUMAN PRESCRIPTION DRUG LABEL	2
Metformin Hydrochloride	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	5
Metformin Hydrochloride Extended-Release Tablets, USP	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	3
Metformin Hydrochloride Extended-Release Tablets, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-19	HUMAN PRESCRIPTION DRUG LABEL	5
Metformin ER 50mg	RedPharm Drug, Inc.	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL	9
Metformin Hydrochloride	A-S Medication Solutions	2020-02-26	HUMAN PRESCRIPTION DRUG LABEL	1
Metformin Hydrochloride Extended-Release Tablets, USP	Unit Dose Services	2018-09-27	HUMAN PRESCRIPTION DRUG LABEL	2