METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Product NDC: 49483-623
Requested package NDC: 49483-623-01
11-digit product format: 494830623
Labeler code: 49483
Product ID: 49483-623_4d845f5a-3ab1-b5ac-e063-6394a90a75d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC
Application: ANDA090295
Marketing category: ANDA
Marketing start: 2016-05-12
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

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49483-623	49483-623-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49483-623	49483-623-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49483-623	49483-623-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A090295-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-04-29
A090295-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090295-001	AB1
A090295-002	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	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`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	A090295-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090295-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090295-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090295-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090295-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090295-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090295-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090295-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090295-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090295-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090295-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090295-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090295-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090295-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090295-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090295-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090295-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090295-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090295-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090295-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090295-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090295-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090295-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090295-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090295-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090295-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090295-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090295-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090295-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090295-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090295-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090295-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090295-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090295-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090295-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090295-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090295-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090295-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090295-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090295-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: METFORMIN HYDROCHLORIDE EXTENDED RELEASE
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
1d8b8970-c2a1-4780-be87-ab8ccfd401fa	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
49483-623-01	2025-02-10	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-09	2025-02-10	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-10	2025-02-10	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-50	2025-02-10	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-01	2025-01-30	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-09	2025-01-30	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-10	2025-01-30	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-50	2025-01-30	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-623-01	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100	10
49483-623-09	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	90 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	90	10
49483-623-10	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	1000 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	1000	10
49483-623-50	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	500 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	500	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-623-01	EA - Each	49483-623	d44d57e6-1b0b-4e9c-aab6-b3cba19b7a90	1	2016-10-06
49483-623-09	EA - Each	49483-623	a5375153-91cf-4c85-846b-b5457a1ec911	1	2017-08-11
49483-623-10	EA - Each	49483-623	800d903c-d568-470b-a1a5-25c6264379fd	1	2017-08-11
49483-623-50	EA - Each	49483-623	a03b6633-c6cc-4a55-afdb-e9176d647855	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE E/R (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	2
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE E/R (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	METFORMIN HYDROCHLORIDE E/R (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE E/R (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE E/R (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-623	METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [TIME CAP LABORATORIES, INC]	9	Current NDC, Legacy NDC, 4 package rows	20250212_1d8b8970-c2a1-4780-be87-ab8ccfd401fa.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	14f3091c-f243-4364-b433-727c7d4ef8d5	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	MARKSANS PHARMA LIMITED	d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d1d7204a-7e8a-4f76-bf9f-3e798c2632ba	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	4e5a19c6-6ac6-ffc0-e063-6394a90a9827	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	TIME CAP LABORATORIES, INC	1d8b8970-c2a1-4780-be87-ab8ccfd401fa	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090295 application number: ANDA090295 ndc (package): 49483-623-01 ndc (product): 49483-623 ndc11 (package): 49483062301
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	d7c1ff9e-4faa-4f65-9c87-e8108499791f	2025-03-28	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	3e55944a-ed5b-4892-804f-abbe15b0d70c	2025-03-28	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Proficient Rx LP	f1530d4f-21d9-4a4f-a814-07b180828ecd	2025-02-01	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	direct rx	a84cf1a3-3820-cd1b-e053-2995a90acf45	2025-01-22	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4a53ea53-3052-614b-e054-00144ff8d46c	2024-07-19	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	0b843f12-a654-4751-be1f-55e6fce163c9	2021-12-08	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295

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	14f3091c-f243-4364-b433-727c7d4ef8d5	18
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	14f3091c-f243-4364-b433-727c7d4ef8d5	18
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	14f3091c-f243-4364-b433-727c7d4ef8d5	18
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	1d8b8970-c2a1-4780-be87-ab8ccfd401fa	10
860981	metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet	PSN	1d8b8970-c2a1-4780-be87-ab8ccfd401fa	10
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	1d8b8970-c2a1-4780-be87-ab8ccfd401fa	10
860981	24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet	SCD	1d8b8970-c2a1-4780-be87-ab8ccfd401fa	10
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	1d8b8970-c2a1-4780-be87-ab8ccfd401fa	10
860981	metformin HCl 750 MG 24 HR Extended Release Oral Tablet	SY	1d8b8970-c2a1-4780-be87-ab8ccfd401fa	10
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	3e55944a-ed5b-4892-804f-abbe15b0d70c	9
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	3e55944a-ed5b-4892-804f-abbe15b0d70c	9
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	3e55944a-ed5b-4892-804f-abbe15b0d70c	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	4a53ea53-3052-614b-e054-00144ff8d46c	5
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	4a53ea53-3052-614b-e054-00144ff8d46c	5
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	4a53ea53-3052-614b-e054-00144ff8d46c	5
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	cc4f5988-cf23-4d6f-8108-5eb6ef8633a9	4
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	cc4f5988-cf23-4d6f-8108-5eb6ef8633a9	4
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	cc4f5988-cf23-4d6f-8108-5eb6ef8633a9	4
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	674bf07f-8123-1204-e053-2991aa0a73b4	2
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	179a4a21-1541-4f96-834f-e80731b62d92	2
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	0b843f12-a654-4751-be1f-55e6fce163c9	2
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	674bf07f-8123-1204-e053-2991aa0a73b4	2
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	179a4a21-1541-4f96-834f-e80731b62d92	2
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	0b843f12-a654-4751-be1f-55e6fce163c9	2
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	674bf07f-8123-1204-e053-2991aa0a73b4	2
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	179a4a21-1541-4f96-834f-e80731b62d92	2
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	0b843f12-a654-4751-be1f-55e6fce163c9	2
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	4e5a19c6-6ac6-ffc0-e063-6394a90a9827	1
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	4e5a19c6-6ac6-ffc0-e063-6394a90a9827	1
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	4e5a19c6-6ac6-ffc0-e063-6394a90a9827	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-623-01	49483062301	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-01)	2016-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	PD-Rx Pharmaceuticals, Inc.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	19
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	TIME CAP LABORATORIES, INC \| MARKSANS PHARMA LIMITED	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL	10
METFORMIN ER TABLETS	Bryant Ranch Prepack	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	9
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	direct rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	8
METFORMIN HYDROCHLORIDE EXTENDED RELEASE - NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc.	2024-07-19	HUMAN PRESCRIPTION DRUG LABEL	5
METFORMIN ER TABLETS	RPK Pharmaceuticals, Inc.	2023-10-23	HUMAN PRESCRIPTION DRUG LABEL	2
METFORMIN ER TABLETS	Aphena Pharma Solutions - Tennessee, LLC	2021-12-08	HUMAN PRESCRIPTION DRUG LABEL	2
623R-624R METFORMIN ER TABLETS	Preferred Pharmaceuticals Inc.	2021-07-16	HUMAN PRESCRIPTION DRUG LABEL	5
METFORMIN HYDROCHLORIDE - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-11-06	HUMAN PRESCRIPTION DRUG LABEL	1
METFORMIN HYDROCHLORIDE	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
METFORMIN ER TABLETS	Bryant Ranch Prepack	2019-09-11	HUMAN PRESCRIPTION DRUG LABEL	1
623R-624R METFORMIN ER TABLETS	REMEDYREPACK INC.	2019-07-23	HUMAN PRESCRIPTION DRUG LABEL	3
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	St. Marys Medical Park Pharmacy \| St. Mary's Medical Park Pharmacy \| MARKSANS PHARMA LIMITED	2018-11-15	HUMAN PRESCRIPTION DRUG LABEL	3
METFORMIN HYDROCHLORIDE	DirectRX	2017-11-06	HUMAN PRESCRIPTION DRUG LABEL	4