METFORMIN HYDROCHLORIDE

Product NDC: 67877-159
11-digit product format: 678770159
Labeler code: 67877
Product ID: 67877-159_52665dfa-e57e-823b-e063-6294a90a74b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metformin hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Ascend Laboratories, LLC
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: 2027-12-31
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 · 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 · 42 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	A201991-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-01-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A201991-001	AB1	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: METFORMIN HYDROCHLORIDE
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 · 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
a944a167-e3ac-4084-af1c-22b48713471c	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
67877-159-01	METFORMIN HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	9
67877-159-05	METFORMIN HYDROCHLORIDE	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	9
67877-159-10	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
67877-159-01	EA - Each	67877-159	0f49d07c-02d4-404e-b49c-920880c765a7	1	2013-06-04
67877-159-05	EA - Each	67877-159	eaadf8a4-b0c2-4c66-a746-034d0d1a64fe	1	2013-06-04
67877-159-10	EA - Each	67877-159	4b4c7393-c039-4d27-9531-0e0beaa21789	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]	1
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-159	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]	5	Current NDC, Legacy NDC, 3 package rows	20210108_a944a167-e3ac-4084-af1c-22b48713471c.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.	f55a245b-a786-4a4a-b11c-c61d48294b01	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201991 application number: ANDA201991
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 ndc (product): 67877-159
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	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
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	88f1fd59-6906-9755-e053-2a95a90acc61	16
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	88f1fd59-6906-9755-e053-2a95a90acc61	16
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	88f1fd59-6906-9755-e053-2a95a90acc61	16
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	0cd086d6-3ae2-476e-b93e-29055e67e8fc	15
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	0cd086d6-3ae2-476e-b93e-29055e67e8fc	15
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	0cd086d6-3ae2-476e-b93e-29055e67e8fc	15
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	9171d369-d35a-40e4-a9ad-26484e66fc5e	14
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	9171d369-d35a-40e4-a9ad-26484e66fc5e	14
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	9171d369-d35a-40e4-a9ad-26484e66fc5e	14
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	a944a167-e3ac-4084-af1c-22b48713471c	9
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	a944a167-e3ac-4084-af1c-22b48713471c	9
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	a944a167-e3ac-4084-af1c-22b48713471c	9
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	5bb945c1-954a-4d43-aa24-33767d19c57c	7
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	f55a245b-a786-4a4a-b11c-c61d48294b01	7
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	5bb945c1-954a-4d43-aa24-33767d19c57c	7
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	f55a245b-a786-4a4a-b11c-c61d48294b01	7
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	f55a245b-a786-4a4a-b11c-c61d48294b01	7
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	5bb945c1-954a-4d43-aa24-33767d19c57c	7
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	3ba957ea-28ed-4a61-a318-98064ea4944d	6
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	3ba957ea-28ed-4a61-a318-98064ea4944d	6
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	3ba957ea-28ed-4a61-a318-98064ea4944d	6
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	f2318509-9a49-4c99-a08b-22381f17aacd	5
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	f2318509-9a49-4c99-a08b-22381f17aacd	5
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	f2318509-9a49-4c99-a08b-22381f17aacd	5
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	07d8a69f-30d9-7511-e063-6394a90a95ca	3
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	a434b937-2648-4509-8ce8-94a28582ec77	3
1807917	metFORMIN HCl 500 MG Osmotic 24HR Extended Release Oral Tablet	PSN	4be72741-4f6d-6689-e054-00144ff8d46c	3
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	07d8a69f-30d9-7511-e063-6394a90a95ca	3
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	a434b937-2648-4509-8ce8-94a28582ec77	3
1807917	Osmotic 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	4be72741-4f6d-6689-e054-00144ff8d46c	3
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	a434b937-2648-4509-8ce8-94a28582ec77	3
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	07d8a69f-30d9-7511-e063-6394a90a95ca	3
1807917	metformin HCl 500 MG Osmotic 24HR Extended Release Oral Tablet	SY	4be72741-4f6d-6689-e054-00144ff8d46c	3
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	1ea02753-c9d0-3b4c-e054-00144ff8d46c	2
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	1ea02753-c9d0-3b4c-e054-00144ff8d46c	2
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	1ea02753-c9d0-3b4c-e054-00144ff8d46c	2
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	784a6bbd-4f13-45ed-89c1-154b06721ed0	1
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	4adeddf2-f449-4a61-9658-dfbff7c50230	1
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	1a047fc0-196e-79af-e063-6394a90a1e0d	1
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	784a6bbd-4f13-45ed-89c1-154b06721ed0	1
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	1a047fc0-196e-79af-e063-6394a90a1e0d	1
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	4adeddf2-f449-4a61-9658-dfbff7c50230	1
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	4adeddf2-f449-4a61-9658-dfbff7c50230	1
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	784a6bbd-4f13-45ed-89c1-154b06721ed0	1
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	1a047fc0-196e-79af-e063-6394a90a1e0d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-159-01	67877015901	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-159-01)	2016-11-25	0000-00-00	No	No	Current
67877-159-05	67877015905	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-159-05)	2016-11-25	0000-00-00	No	No	Current
67877-159-10	67877015910	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-159-10)	2016-11-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	8
METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	15
METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC \| Inventia Healthcare Limited	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	11
METFORMIN HYDROCHLORIDE	QPharma Inc \| Northwind Health Company, LLC	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
METFORMIN HCL ER	Direct_Rx	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride Extended Release Tablets USP	Proficient Rx LP	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	6
METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Metformin Hydrochloride Extended Release Tablets USP	NuCare Pharmaceuticals, Inc.	2025-09-22	HUMAN PRESCRIPTION DRUG LABEL	3
METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	2025-08-25	HUMAN PRESCRIPTION DRUG LABEL	5
METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2025-06-18	HUMAN PRESCRIPTION DRUG LABEL	15
METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2025-06-17	HUMAN PRESCRIPTION DRUG LABEL	3
METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2025-06-17	HUMAN PRESCRIPTION DRUG LABEL	1
METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2025-01-21	HUMAN PRESCRIPTION DRUG LABEL	1
METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-23	HUMAN PRESCRIPTION DRUG LABEL	7
METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2024-06-03	HUMAN PRESCRIPTION DRUG LABEL	1
Metformin ER 500mg	RedPharm Drug, Inc.	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL	16
METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	2020-04-06	HUMAN PRESCRIPTION DRUG LABEL	5
Metformin Hydrochloride Extended Release Tablets USP	Blenheim Pharmacal, Inc.	2015-09-02	HUMAN PRESCRIPTION DRUG LABEL	2