Metformin Hydrochloride

Product NDC: 70010-064
Requested package NDC: 70010-064-16
11-digit product format: 700100064
Labeler code: 70010
Product ID: 70010-064_0266503f-0f1a-38e0-e063-6294a90a606f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA090564
Marketing category: ANDA
Marketing start: 2019-06-26
Substance: METFORMIN HYDROCHLORIDE
Active strength: 850 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	70010-064	70010-064-16	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

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 · 20 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`

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	RLD / RS	Approval date
A090564-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22
A090564-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22
A090564-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090564-001	AB
A090564-002	AB
A090564-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`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	A090564-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090564-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090564-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090564-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090564-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090564-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090564-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090564-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090564-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090564-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090564-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090564-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090564-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090564-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090564-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090564-001	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	850 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
2387a618-24d8-4813-aa83-9114edb35374	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70010-064-01	Metformin Hydrochloride	100 in 1 BOTTLE	TABLET	100	6
70010-064-05	Metformin Hydrochloride	500 in 1 BOTTLE	TABLET	500	6
70010-064-06	Metformin Hydrochloride	60 in 1 BOTTLE	TABLET	60	6
70010-064-09	Metformin Hydrochloride	90 in 1 BOTTLE	TABLET	90	6
70010-064-10	Metformin Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	6
70010-064-99	Metformin Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-064-01	EA - Each	70010-064	f30af531-eb4f-471d-b7d6-23d61fd3fb60	1	2020-05-08
70010-064-05	EA - Each	70010-064	b66f1b02-cf4f-400f-80fa-3a62c4b02984	1	2020-05-08
70010-064-09	EA - Each	70010-064	2fc086c8-7957-4d32-885b-af148a4d4ee8	1	2021-04-08
70010-064-10	EA - Each	70010-064	12355609-eb58-4885-bbc6-3b122384e230	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-064	METFORMIN HYDROCHLORIDE TABLET [GRANULES PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 6 package rows	20230810_2387a618-24d8-4813-aa83-9114edb35374.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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	30658e19-8e6e-49aa-a007-e414224797c5	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Cardinal Health 107, LLC	46cb7e3f-c739-433d-9dbe-427c2d95bef1	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5aa1c86c-f2c8-49b1-8f81-47b11386c5d3	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	PD-Rx Pharmaceuticals, Inc.	fb890205-5d43-41eb-97b2-fb0dcdd3a950	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE TABLET	Granules India Ltd	8cd5555c-f6b2-28d8-e053-2a95a90a5f1e	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Unit Dose Solutions, Inc.	5538e9df-0983-9281-e063-6394a90a9249	2026-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	552ad61d-bafd-478d-e063-6294a90a02f9	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Unit Dose Solutions, Inc.	552df462-6dcb-e6f2-e063-6294a90aacfe	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Major Pharmaceuticals	5e783025-bf6d-465e-bf58-bcd253afad2c	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c3	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	902d1bc4-3f1f-4a1a-86d7-cf98c56a3684	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	33550b88-d4bb-4ce6-a7db-07c966f6984f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	53e950f5-c58f-78e3-e063-6294a90a53e9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Proficient Rx LP	d2c927eb-12bf-4c7d-9ef5-0036b2dd8c29	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Northwind Health Company, LLC	13b1e35f-d047-8ddc-e063-6394a90a24dd	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	51285096-e2ce-0f3c-e063-6394a90a35d4	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Granules Pharmaceuticals Inc.	2387a618-24d8-4813-aa83-9114edb35374	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (product): 70010-064
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	59a4ccda-5487-4ac4-9373-0c0fc8b7c88b	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	b51da8d7-ab4a-4c40-97c9-88bd379366d1	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564

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
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa	16
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa	16
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	b51da8d7-ab4a-4c40-97c9-88bd379366d1	14
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	b51da8d7-ab4a-4c40-97c9-88bd379366d1	14
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	b51da8d7-ab4a-4c40-97c9-88bd379366d1	14
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	b51da8d7-ab4a-4c40-97c9-88bd379366d1	14
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	b51da8d7-ab4a-4c40-97c9-88bd379366d1	14
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	b51da8d7-ab4a-4c40-97c9-88bd379366d1	14
861004	metformin HCl 1 GM Oral Tablet	SY	b51da8d7-ab4a-4c40-97c9-88bd379366d1	14
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	2387a618-24d8-4813-aa83-9114edb35374	6
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	2387a618-24d8-4813-aa83-9114edb35374	6
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	2387a618-24d8-4813-aa83-9114edb35374	6
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	2387a618-24d8-4813-aa83-9114edb35374	6
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	2387a618-24d8-4813-aa83-9114edb35374	6
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	2387a618-24d8-4813-aa83-9114edb35374	6
861004	metformin HCl 1 GM Oral Tablet	SY	2387a618-24d8-4813-aa83-9114edb35374	6
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	5e783025-bf6d-465e-bf58-bcd253afad2c	5
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	5e783025-bf6d-465e-bf58-bcd253afad2c	5
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	5e783025-bf6d-465e-bf58-bcd253afad2c	5
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	5e783025-bf6d-465e-bf58-bcd253afad2c	5
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	5e783025-bf6d-465e-bf58-bcd253afad2c	5
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	5e783025-bf6d-465e-bf58-bcd253afad2c	5
861004	metformin HCl 1 GM Oral Tablet	SY	5e783025-bf6d-465e-bf58-bcd253afad2c	5
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	902d1bc4-3f1f-4a1a-86d7-cf98c56a3684	3
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	d0bc43a4-301f-4002-9b58-bd81dddf2790	3
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	d0bc43a4-301f-4002-9b58-bd81dddf2790	3
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	902d1bc4-3f1f-4a1a-86d7-cf98c56a3684	3
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	041632fa-9bf4-8d7c-e063-6294a90adefb	2
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	041632fa-9bf4-8d7c-e063-6294a90adefb	2
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	a4679179-af2d-4c84-a1c8-ab0870a4585d	1
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	a4679179-af2d-4c84-a1c8-ab0870a4585d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
70010-064-16	70010006416	32857 TABLET in 1 DRUM (70010-064-16)	32857 tablet	07-JUN-19	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride	REMEDYREPACK INC.	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	17
Metformin Hydrochloride	Major Pharmaceuticals	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	6
Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride	Coupler LLC	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	1
Metformin Hydrochloride	Granules Pharmaceuticals Inc. \| Granules India Ltd \| GRANULES LIFE SCIENCES PRIVATE LIMITED	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	7
Metformin hydrochloride	Legacy Pharmaceutical Packaging, LLC	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	14
Metformin Hydrochloride Tablets, USP	Granules Pharmaceuticals Inc	2024-08-27	BULK INGREDIENT	8
Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	2
Metformin Hydrochloride	A-S Medication Solutions	2023-10-20	HUMAN PRESCRIPTION DRUG LABEL	3
Metformin Hydrochloride	A-S Medication Solutions	2023-10-18	HUMAN PRESCRIPTION DRUG LABEL	1