Metformin Hydrochloride

Product NDC: 65162-219
11-digit product format: 651620219
Labeler code: 65162
Product ID: 65162-219_cbbbd23f-982c-4f27-89c6-2568a283aecd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA077880
Marketing category: ANDA
Marketing start: 2012-12-17
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 850 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65162-219		D	Discontinued by firm	2026-08-03
excluded product	product	65162-219		D	Discontinued by firm	2026-08-03
excluded package	package	65162-219	65162-219-10	D	Discontinued by firm	2026-08-03
excluded package	package	65162-219	65162-219-11	D	Discontinued by firm	2026-08-03
excluded package	package	65162-219	65162-219-50	D	Discontinued by firm	2026-08-03
excluded package	package	65162-219	65162-219-03	D	Discontinued by firm	2026-08-03
excluded package	package	65162-219	65162-219-10	D	Discontinued by firm	2026-08-03
excluded package	package	65162-219	65162-219-11	D	Discontinued by firm	2026-08-03
excluded package	package	65162-219	65162-219-50	D	Discontinued by firm	2026-08-03

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65162-219-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65162-219-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65162-219-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65162-219-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65162-219-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65162-219-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65162-219-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65162-219-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65162-219-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65162-219-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65162-219-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65162-219-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65162-219-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65162-219-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65162-219-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65162-219-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65162-219-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65162-219-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65162-219-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65162-219-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65162-219-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65162-219-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65162-219-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65162-219-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65162-219-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65162-219-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65162-219-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65162-219-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65162-219-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65162-219-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65162-219-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65162-219-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65162-219-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65162-219-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65162-219-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65162-219-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A077880-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2006-06-05
A077880-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2006-06-05
A077880-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2006-06-05

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	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL		2006-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL		2006-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL		2006-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2006-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2006-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2006-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2006-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2006-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2006-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2006-06-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077880-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077880-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077880-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077880-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077880-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077880-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077880-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077880-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077880-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077880-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077880-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077880-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077880-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077880-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077880-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077880-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077880-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077880-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077880-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077880-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077880-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077880-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077880-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077880-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077880-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077880-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077880-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077880-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077880-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077880-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077880-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077880-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077880-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077880-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077880-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077880-001	AB	1	`3f01610625f2…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-219-10	EA - Each	65162-219	1e691632-9c2e-47aa-85fc-3074f213b9ca	1	2013-02-11
65162-219-11	EA - Each	65162-219	f133dce9-212a-49a9-abca-f29914775773	1	2013-02-11
65162-219-50	EA - Each	65162-219	c9c42e2e-f6cc-467c-bde7-b85856a11ff9	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
ACACIA	INACTIVE INGREDIENT	5C5403N26O	METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-219	METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC]	19	Legacy NDC	20241031_14544c2f-88c8-48a5-941e-48a543d7baaa.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	0230a3c3-34cf-478b-88c3-4d96e5300018	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077880 application number: ANDA077880
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	c72cfd1a-dce9-43a3-88e2-3cf1d9078b52	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077880 application number: ANDA077880
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	b090b18b-b53c-4c92-892f-d11551cfedc3	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077880 application number: ANDA077880

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-219-03	65162021903	30 TABLET in 1 BOTTLE (65162-219-03)	30 tablet	2012-12-17	0000-00-00	No	No	Current
65162-219-10	65162021910	100 TABLET in 1 BOTTLE (65162-219-10)	100 tablet	2012-12-17	0000-00-00	No	No	Current
65162-219-11	65162021911	1000 TABLET in 1 BOTTLE (65162-219-11)	1000 tablet	2012-12-17	0000-00-00	No	No	Current
65162-219-50	65162021950	500 TABLET in 1 BOTTLE (65162-219-50)	500 tablet	2012-12-17	0000-00-00	No	No	Current