METFORMIN HYDROCHLORIDE

Product NDC: 0615-8289
11-digit product format: 006158289
Labeler code: 0615
Product ID: 0615-8289_e3d84126-2927-4507-aaef-6fc37fc5b105
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metformin hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA201991
Marketing category: ANDA
Marketing start: 2013-03-01
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201991-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2012-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201991-001	AB1

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 2 · 41 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	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A201991-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201991-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201991-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201991-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201991-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201991-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201991-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201991-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201991-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201991-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201991-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201991-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201991-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201991-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201991-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201991-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201991-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201991-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201991-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201991-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201991-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201991-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201991-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201991-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201991-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201991-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201991-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201991-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201991-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201991-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201991-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201991-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201991-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201991-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201991-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201991-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201991-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201991-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201991-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201991-001	AB1	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: METFORMIN HYDROCHLORIDE
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860975	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
5bb945c1-954a-4d43-aa24-33767d19c57c	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	Strength	SPL version
0615-8289-28	METFORMIN HYDROCHLORIDE	28 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	28		7
0615-8289-39	METFORMIN HYDROCHLORIDE	30 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	30		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8289	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	7	Current NDC, Legacy NDC, 2 package rows	20240828_5bb945c1-954a-4d43-aa24-33767d19c57c.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 HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9171d369-d35a-40e4-a9ad-26484e66fc5e	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE ER	METFORMIN HYDROCHLORIDE	Leading Pharma, LLC	3dca884d-ec44-496f-9eeb-31fd8fa3f574	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	a944a167-e3ac-4084-af1c-22b48713471c	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	QPharma Inc	5269e91f-7e93-9405-e063-6294a90a3217	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	3ba957ea-28ed-4a61-a318-98064ea4944d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	07d8a69f-30d9-7511-e063-6394a90a95ca	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4be72741-4f6d-6689-e054-00144ff8d46c	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	f2318509-9a49-4c99-a08b-22381f17aacd	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f55a245b-a786-4a4a-b11c-c61d48294b01	2025-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	0cd086d6-3ae2-476e-b93e-29055e67e8fc	2025-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	a434b937-2648-4509-8ce8-94a28582ec77	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	784a6bbd-4f13-45ed-89c1-154b06721ed0	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4adeddf2-f449-4a61-9658-dfbff7c50230	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5bb945c1-954a-4d43-aa24-33767d19c57c	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991 ndc (product): 0615-8289
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1a047fc0-196e-79af-e063-6394a90a1e0d	2024-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991

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	5bb945c1-954a-4d43-aa24-33767d19c57c	7
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	5bb945c1-954a-4d43-aa24-33767d19c57c	7
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	5bb945c1-954a-4d43-aa24-33767d19c57c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8289-28	00615828928	28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-28)	2024-03-28		No	No	Current
0615-8289-39	00615828939	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-39)	2019-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-23	HUMAN PRESCRIPTION DRUG LABEL	7