Metformin Hydrochloride

Product NDC: 42385-949
11-digit product format: 423850949
Labeler code: 42385
Product ID: 42385-949_d2500c46-4274-4a87-b4bf-3a3bfc361630
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Laurus Labs Limited
Application: ANDA209882
Marketing category: ANDA
Marketing start: 2021-05-17
Substance: METFORMIN HYDROCHLORIDE
Active strength: 1000 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209882-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27
A209882-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27
A209882-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209882-001	AB
A209882-002	AB
A209882-003	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 4 · 123 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	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A209882-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209882-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209882-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209882-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209882-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209882-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209882-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209882-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209882-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209882-001	AB	1	`8072bd15b7f6…`

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	1000 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861004	Internal RxNorm lookup
861007	Internal RxNorm lookup
861010	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
c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42385-949-01	Metformin Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	7
42385-949-05	Metformin Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	7
42385-949-11	Metformin Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	7
42385-949-18	Metformin Hydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180	7
42385-949-19	Metformin Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	7
42385-949-19	Metformin Hydrochloride	10 in 1 CARTON	TABLET, FILM COATED	10	7
42385-949-60	Metformin Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	7
42385-949-90	Metformin Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42385-949-01	EA - Each	42385-949	7a320932-64f3-45f6-b2e0-1d6b6daf247a	1	2023-01-09
42385-949-05	EA - Each	42385-949	69fd259e-4b3f-430f-8604-e056b36b5f6b	1	2023-01-09
42385-949-11	EA - Each	42385-949	af4d8f35-6120-4a13-8427-a91ba1b1d049	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42385-949	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAURUS LABS LIMITED]	5	Current NDC, Legacy NDC, 8 package rows	20230922_c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f4fc759a-057e-4b5d-b8ab-13bc5eeb24e4	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	400ff9dc-9789-44ac-afb5-730b632a1667	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Laurus Labs Limited	c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882 ndc (product): 42385-949
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	be023bca-511e-4801-bd2b-e30dd1408772	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin HCL	METFORMIN HCL	Direct_Rx	498ac5fc-14be-d36a-e063-6394a90a3012	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	8c248958-6c01-455e-89f5-959facb272ed	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f59ceea4-a84a-4082-8e73-7c6f340c28d6	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	192970d3-826a-4b69-a525-9742794dc19c	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ca71c133-6c38-4b9e-80af-1949634157f4	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	0178b9dd-bafa-9e81-e063-6294a90a88b0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	bfd6ec0f-8264-4877-aa6d-f347f53bc426	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	3eeee3b7-188a-05a0-e063-6294a90a1853	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e1ebb146-acfd-4301-a79c-f5bb243f8575	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	33155746-c2ef-12f4-e063-6294a90a039c	2025-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	0f251f2c-97f3-4048-84f2-81fea03685aa	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	286d959a-51cb-4dbd-a3e8-1ea2f00b54c7	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	ed6e6f87-ddd7-4c9d-a263-47154d3a9478	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c2783b59-7b20-4d4c-a3ca-03ed60dcf2c3	2024-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2be73d5e-7682-4ad3-831b-8c1ea73e38de	2024-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882

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
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	7
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	7
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	7
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	7
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	7
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	7
861004	metformin HCl 1 GM Oral Tablet	SY	c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	7
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	0178b9dd-bafa-9e81-e063-6294a90a88b0	4
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	8c248958-6c01-455e-89f5-959facb272ed	4
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	400ff9dc-9789-44ac-afb5-730b632a1667	4
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	0178b9dd-bafa-9e81-e063-6294a90a88b0	4
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	8c248958-6c01-455e-89f5-959facb272ed	4
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	400ff9dc-9789-44ac-afb5-730b632a1667	4
861004	metformin HCl 1 GM Oral Tablet	SY	0178b9dd-bafa-9e81-e063-6294a90a88b0	4
861004	metformin HCl 1 GM Oral Tablet	SY	8c248958-6c01-455e-89f5-959facb272ed	4
861004	metformin HCl 1 GM Oral Tablet	SY	400ff9dc-9789-44ac-afb5-730b632a1667	4
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	f4fc759a-057e-4b5d-b8ab-13bc5eeb24e4	3
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	f4fc759a-057e-4b5d-b8ab-13bc5eeb24e4	3
861004	metformin HCl 1 GM Oral Tablet	SY	f4fc759a-057e-4b5d-b8ab-13bc5eeb24e4	3
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	bfd6ec0f-8264-4877-aa6d-f347f53bc426	2
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	04540238-7aae-2897-e063-6294a90a097b	2
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	e1ebb146-acfd-4301-a79c-f5bb243f8575	2
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	bfd6ec0f-8264-4877-aa6d-f347f53bc426	2
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	04540238-7aae-2897-e063-6294a90a097b	2
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	e1ebb146-acfd-4301-a79c-f5bb243f8575	2
861004	metformin HCl 1 GM Oral Tablet	SY	bfd6ec0f-8264-4877-aa6d-f347f53bc426	2
861004	metformin HCl 1 GM Oral Tablet	SY	04540238-7aae-2897-e063-6294a90a097b	2
861004	metformin HCl 1 GM Oral Tablet	SY	e1ebb146-acfd-4301-a79c-f5bb243f8575	2
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	286d959a-51cb-4dbd-a3e8-1ea2f00b54c7	1
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	2655ec6d-4528-91ef-e063-6394a90a4386	1
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	2655ec6d-4528-91ef-e063-6394a90a4386	1
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	286d959a-51cb-4dbd-a3e8-1ea2f00b54c7	1
861004	metformin HCl 1 GM Oral Tablet	SY	2655ec6d-4528-91ef-e063-6394a90a4386	1
861004	metformin HCl 1 GM Oral Tablet	SY	286d959a-51cb-4dbd-a3e8-1ea2f00b54c7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42385-949-01	42385094901	100 TABLET, FILM COATED in 1 BOTTLE (42385-949-01)		2021-07-20	0000-00-00	No	No	Current
42385-949-05	42385094905	500 TABLET, FILM COATED in 1 BOTTLE (42385-949-05)		2021-07-20	0000-00-00	No	No	Current
42385-949-11	42385094911	1000 TABLET, FILM COATED in 1 BOTTLE (42385-949-11)		2021-05-17	0000-00-00	No	No	Current
42385-949-18	42385094918	180 TABLET, FILM COATED in 1 BOTTLE (42385-949-18)		2021-07-20	0000-00-00	No	No	Current
42385-949-19	42385094919	10 BLISTER PACK in 1 CARTON (42385-949-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2021-05-17	0000-00-00	No	No	Current
42385-949-60	42385094960	60 TABLET, FILM COATED in 1 BOTTLE (42385-949-60)		2021-05-17	0000-00-00	No	No	Current
42385-949-90	42385094990	90 TABLET, FILM COATED in 1 BOTTLE (42385-949-90)		2022-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride	A-S Medication Solutions	2026-06-12	Human Prescription Drug Label	6
Metformin Hydrochloride	A-S Medication Solutions	2026-06-12	Human Prescription Drug Label	5
Metformin Hydrochloride	Laurus Labs Limited \| Laurus Labs Limited (VSP2)	2026-05-15	Human Prescription Drug Label	7
Metformin Hydrochloride	A-S Medication Solutions	2026-01-29	Human Prescription Drug Label	4
Metformin Hydrochloride	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride	REMEDYREPACK INC.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	2
Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	2025-08-06	HUMAN PRESCRIPTION DRUG LABEL	2
Metformin Hydrochloride	Bryant Ranch Prepack	2024-12-10	HUMAN PRESCRIPTION DRUG LABEL	1
Metformin Hydrochloride	Coupler LLC	2024-11-07	HUMAN PRESCRIPTION DRUG LABEL	1
Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	2023-09-18	HUMAN PRESCRIPTION DRUG LABEL	2