Metformin

Product NDC: 70010-491
11-digit product format: 700100491
Labeler code: 70010
Product ID: 70010-491_451bc376-d523-ee84-e063-6394a90a4743
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin ER 500 mg
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA209313
Marketing category: ANDA
Marketing start: 2018-07-31
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209313-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-03-16
A209313-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209313-001	AB1
A209313-002	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 · 84 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	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-03-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A209313-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209313-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209313-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209313-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209313-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209313-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209313-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209313-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209313-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209313-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209313-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209313-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209313-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209313-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209313-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209313-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209313-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209313-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209313-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209313-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209313-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209313-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209313-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209313-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209313-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209313-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209313-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209313-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209313-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209313-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209313-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209313-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209313-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209313-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209313-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209313-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209313-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209313-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209313-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209313-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metformin
Listing expiration: 2027-12-31

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
6d6ee6f8-9650-ff4f-e053-2991aa0acf19	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
70010-491-01	Metformin	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	19
70010-491-05	Metformin	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	19
70010-491-09	Metformin	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	19
70010-491-10	Metformin	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	19
70010-491-18	Metformin	5000 in 1 POUCH	TABLET, EXTENDED RELEASE	5000	19
70010-491-19	Metformin	25000 in 1 CARTON	TABLET, EXTENDED RELEASE	25000	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-491-01	EA - Each	70010-491	b67f0f6c-3e17-4980-902e-fb0a67518209	1	2019-02-13
70010-491-05	EA - Each	70010-491	10646451-2fb5-4fc1-8b3e-a2151b7ce207	1	2019-02-13
70010-491-09	EA - Each	70010-491	fb51e19d-32de-4ba0-954f-e3faf0ab8fca	1	2020-08-06
70010-491-10	EA - Each	70010-491	16eba94e-3cda-4acc-9d9f-3f24f2d75fcb	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-491	METFORMIN (METFORMIN ER 500 MG) TABLET, EXTENDED RELEASE METFORMIN (METFORMIN ER 750 MG) TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]	18	Current NDC, Legacy NDC, 6 package rows	20240704_6d6ee6f8-9650-ff4f-e053-2991aa0acf19.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin ER 500 mg	METFORMIN ER 500 MG	Granules India Ltd	b857eccf-b9ff-45ba-8241-f47f5caada2a	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Coupler LLC	54620ea3-da64-c5d7-e063-6394a90ad14a	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Granules Pharmaceuticals Inc.	6d6ee6f8-9650-ff4f-e053-2991aa0acf19	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313 ndc (product): 70010-491
Metformin	METFORMIN ER 500 MG	Bryant Ranch Prepack	c047cf64-467a-40f3-be46-a1926b3b8d56	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Legacy Pharmaceutical Packaging, LLC	d9e0816d-fd61-1ac2-e053-2995a90a4054	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin ER 500 mg	METFORMIN ER 500 MG	Quallent Pharmaceuticals Health LLC	ff196435-14f4-8b9d-e053-6294a90a4ee8	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	REMEDYREPACK INC.	05999192-ebc6-4198-bd1e-f46abbfb4f8a	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	A-S Medication Solutions	fdd3481c-aaec-47ac-9790-01de68b2e253	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 750 MG	Bryant Ranch Prepack	f1058475-1318-49a0-89ce-da06692b0e5b	2024-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Proficient Rx LP	92855c8d-59be-458b-97f1-2ff11b9bf6b0	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 750 MG	A-S Medication Solutions	9e3791fb-9a34-4982-8164-0502fa398b01	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 750 MG	A-S Medication Solutions	953404a4-0f03-42f1-8136-43238dad11f4	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Bryant Ranch Prepack	1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	A-S Medication Solutions	c6fddb05-6b9b-4088-8ce7-17fb94c13cc2	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Aphena Pharma Solutions - Tennessee, LLC	5c10eaa2-d6ba-446a-8f16-f5a8ca7223d7	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313

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	c047cf64-467a-40f3-be46-a1926b3b8d56	101
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4	101
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4	101
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	c047cf64-467a-40f3-be46-a1926b3b8d56	101
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4	101
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	c047cf64-467a-40f3-be46-a1926b3b8d56	101
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	d9e0816d-fd61-1ac2-e053-2995a90a4054	19
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	6d6ee6f8-9650-ff4f-e053-2991aa0acf19	19
860981	metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet	PSN	6d6ee6f8-9650-ff4f-e053-2991aa0acf19	19
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	d9e0816d-fd61-1ac2-e053-2995a90a4054	19
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	6d6ee6f8-9650-ff4f-e053-2991aa0acf19	19
860981	24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet	SCD	6d6ee6f8-9650-ff4f-e053-2991aa0acf19	19
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	d9e0816d-fd61-1ac2-e053-2995a90a4054	19
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	6d6ee6f8-9650-ff4f-e053-2991aa0acf19	19
860981	metformin HCl 750 MG 24 HR Extended Release Oral Tablet	SY	6d6ee6f8-9650-ff4f-e053-2991aa0acf19	19
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	c6fddb05-6b9b-4088-8ce7-17fb94c13cc2	6
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	c6fddb05-6b9b-4088-8ce7-17fb94c13cc2	6
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	c6fddb05-6b9b-4088-8ce7-17fb94c13cc2	6
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	fdd3481c-aaec-47ac-9790-01de68b2e253	4
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	92855c8d-59be-458b-97f1-2ff11b9bf6b0	4
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	5c10eaa2-d6ba-446a-8f16-f5a8ca7223d7	4
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	05999192-ebc6-4198-bd1e-f46abbfb4f8a	4
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	92855c8d-59be-458b-97f1-2ff11b9bf6b0	4
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	5c10eaa2-d6ba-446a-8f16-f5a8ca7223d7	4
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	05999192-ebc6-4198-bd1e-f46abbfb4f8a	4
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	fdd3481c-aaec-47ac-9790-01de68b2e253	4
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	05999192-ebc6-4198-bd1e-f46abbfb4f8a	4
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	92855c8d-59be-458b-97f1-2ff11b9bf6b0	4
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	fdd3481c-aaec-47ac-9790-01de68b2e253	4
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	5c10eaa2-d6ba-446a-8f16-f5a8ca7223d7	4
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	f29892f8-142e-4d24-9ccd-5d6b408328cd	3
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	f29892f8-142e-4d24-9ccd-5d6b408328cd	3
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	f29892f8-142e-4d24-9ccd-5d6b408328cd	3
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	e2c52c13-2206-6c71-e053-2a95a90aef0a	1
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	e2c52c13-2206-6c71-e053-2a95a90aef0a	1
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	e2c52c13-2206-6c71-e053-2a95a90aef0a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70010-491-01	70010049101	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-01)	2018-07-31	0000-00-00	No	No	Current
70010-491-05	70010049105	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-05)	2018-07-31	0000-00-00	No	No	Current
70010-491-09	70010049109	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-09)	2020-04-16	0000-00-00	No	No	Current
70010-491-10	70010049110	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-10)	2018-07-31	0000-00-00	No	No	Current
70010-491-18	70010049118	5000 TABLET, EXTENDED RELEASE in 1 POUCH (70010-491-18)	2019-06-14	0000-00-00	No	No	Current
70010-491-19	70010049119	25000 TABLET, EXTENDED RELEASE in 1 CARTON (70010-491-19)	2019-06-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin	Coupler LLC	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	1
Metformin	Granules Pharmaceuticals Inc.	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	20
Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mg	Bryant Ranch Prepack	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	101
Metformin - Legacy Pharmaceutical Packaging, LLC	Legacy Pharmaceutical Packaging, LLC	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	19
Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mg	REMEDYREPACK INC.	2025-08-22	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mg	Preferred Pharmaceuticals Inc.	2025-08-06	HUMAN PRESCRIPTION DRUG LABEL	3
Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mg	A-S Medication Solutions	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mg	REMEDYREPACK INC.	2024-11-19	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride Extended-Release Tablets 500 mg	Proficient Rx LP	2024-11-01	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mg	Bryant Ranch Prepack	2024-08-26	HUMAN PRESCRIPTION DRUG LABEL	101
Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mg	A-S Medication Solutions	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	6
Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mg	Aphena Pharma Solutions - Tennessee, LLC	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride Extended-Release Tablets 500 mg	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	2
Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mg	NuCare Pharmaceuticals,Inc.	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	1