Metformin Hydrochloride

Product NDC: 0378-6001
11-digit product format: 003786001
Labeler code: 0378
Product ID: 0378-6001_7c8e06cd-8ef3-4a03-b4ee-3df6899280cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metformin
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA200690
Marketing category: ANDA
Marketing start: 2016-08-23
Substance: METFORMIN HYDROCHLORIDE
Active strength: 1000 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 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
A200690-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2012-08-01
A200690-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2		2012-08-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200690-001	AB2
A200690-002	AB2

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	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`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	A200690-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200690-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200690-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200690-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200690-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200690-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200690-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200690-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200690-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200690-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200690-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200690-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200690-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200690-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200690-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200690-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200690-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200690-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200690-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200690-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200690-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200690-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200690-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200690-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200690-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200690-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200690-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200690-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200690-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200690-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200690-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200690-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200690-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200690-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200690-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200690-002	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200690-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200690-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200690-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200690-002	AB2	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1807894	Internal RxNorm lookup
1807917	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
7e41818c-60e9-4bcf-9586-7bb8d33d5e89	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-6001-91	Metformin Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-6001-91	EA - Each	0378-6001	c8ccd248-92b8-47bc-8c2d-0faff296a760	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-6001	METFORMIN HYDROCHLORIDE (METFORMIN) TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 1 package rows	20190208_7e41818c-60e9-4bcf-9586-7bb8d33d5e89.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN	Mylan Pharmaceuticals Inc.	7e41818c-60e9-4bcf-9586-7bb8d33d5e89	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200690 application number: ANDA200690 ndc (product): 0378-6001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE
9100L32L2N	METFORMIN	657-24-9	metformin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1807894	metFORMIN HCl 1000 MG Osmotic 24HR Extended Release Oral Tablet	PSN	7e41818c-60e9-4bcf-9586-7bb8d33d5e89	9
1807917	metFORMIN HCl 500 MG Osmotic 24HR Extended Release Oral Tablet	PSN	7e41818c-60e9-4bcf-9586-7bb8d33d5e89	9
1807894	Osmotic 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	7e41818c-60e9-4bcf-9586-7bb8d33d5e89	9
1807917	Osmotic 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	7e41818c-60e9-4bcf-9586-7bb8d33d5e89	9
1807894	metformin HCl 1000 MG Osmotic 24 HR Extended Release Oral Tablet	SY	7e41818c-60e9-4bcf-9586-7bb8d33d5e89	9
1807917	metformin HCl 500 MG Osmotic 24HR Extended Release Oral Tablet	SY	7e41818c-60e9-4bcf-9586-7bb8d33d5e89	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-6001-91	00378600191	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91)	2016-08-23	0000-00-00	No	No	Current