Metformin Hydrochloride

Product NDC: 65162-220
11-digit product format: 651620220
Labeler code: 65162
Product ID: 65162-220_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: 1000 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	65162-220		D	Discontinued by firm	2026-08-03
excluded product	product	65162-220		D	Discontinued by firm	2026-08-03
excluded package	package	65162-220	65162-220-10	D	Discontinued by firm	2026-08-03
excluded package	package	65162-220	65162-220-11	D	Discontinued by firm	2026-08-03
excluded package	package	65162-220	65162-220-50	D	Discontinued by firm	2026-08-03
excluded package	package	65162-220	65162-220-03	D	Discontinued by firm	2026-08-03
excluded package	package	65162-220	65162-220-10	D	Discontinued by firm	2026-08-03
excluded package	package	65162-220	65162-220-11	D	Discontinued by firm	2026-08-03
excluded package	package	65162-220	65162-220-50	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	65162-220-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65162-220-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65162-220-10	`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	65162-220-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65162-220-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65162-220-10	`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	65162-220-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65162-220-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65162-220-10	`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	65162-220-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65162-220-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65162-220-10	`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	65162-220-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65162-220-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65162-220-10	`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	65162-220-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65162-220-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65162-220-10	`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	65162-220-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65162-220-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65162-220-10	`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	65162-220-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65162-220-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65162-220-10	`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	65162-220-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65162-220-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65162-220-10	`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	65162-220-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65162-220-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65162-220-10	`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	65162-220-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65162-220-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65162-220-10	`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	65162-220-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65162-220-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65162-220-10	`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 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-220-10	EA - Each	65162-220	27cc2194-e998-42c2-9ae1-6a3fa815c257	1	2013-02-11
65162-220-11	EA - Each	65162-220	0c42db1e-78f5-4ac5-81b8-f965626d51d3	1	2013-02-11
65162-220-50	EA - Each	65162-220	f2cf1c85-f9ea-49eb-9498-9ab7736f5b9f	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 HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET [READYMEDS]	8
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET [READYMEDS]	8
ACACIA	INACTIVE INGREDIENT	5C5403N26O	METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
ACACIA	INACTIVE INGREDIENT	5C5403N26O	METFORMIN HYDROCHLORIDE TABLET [READYMEDS]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	METFORMIN HYDROCHLORIDE TABLET [READYMEDS]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	METFORMIN HYDROCHLORIDE TABLET [READYMEDS]	8
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-220	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	9411b1e8-6715-4d62-9861-ccc052f65c8e	8
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	9411b1e8-6715-4d62-9861-ccc052f65c8e	8
861004	metformin HCl 1 GM Oral Tablet	SY	9411b1e8-6715-4d62-9861-ccc052f65c8e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-220-03	65162022003	30 TABLET in 1 BOTTLE (65162-220-03)	30 tablet	2012-12-17	0000-00-00	No	No	Current
65162-220-10	65162022010	100 TABLET in 1 BOTTLE (65162-220-10)	100 tablet	2012-12-17	0000-00-00	No	No	Current
65162-220-11	65162022011	1000 TABLET in 1 BOTTLE (65162-220-11)	1000 tablet	2012-12-17	0000-00-00	No	No	Current
65162-220-50	65162022050	500 TABLET in 1 BOTTLE (65162-220-50)	500 tablet	2012-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride	Amneal Pharmaceuticals LLC	2023-08-30	HUMAN PRESCRIPTION DRUG LABEL	19
Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2022-01-19	HUMAN PRESCRIPTION DRUG LABEL	9
Metformin Hydrochloride Tablets, USP	ReadyMeds	2014-06-30	HUMAN PRESCRIPTION DRUG LABEL	8