Metformin Hydrochloride

Product NDC: 65162-175
11-digit product format: 651620175
Labeler code: 65162
Product ID: 65162-175_6fc4d215-86ac-416e-8e9a-5f84b78ef2db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals
Application: ANDA077880
Marketing category: ANDA
Marketing start: 2009-06-01
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC],Biguanides [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65162-175		I	Inactivated by FDA	2026-08-03
excluded package	package	65162-175	65162-175-10	I	Inactivated by FDA	2026-08-03
excluded package	package	65162-175	65162-175-11	I	Inactivated by FDA	2026-08-03
excluded package	package	65162-175	65162-175-50	I	Inactivated by FDA	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 2 · 88 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	65162-175-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65162-175-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65162-175-50	`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	65162-175-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65162-175-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65162-175-50	`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	65162-175-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65162-175-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65162-175-50	`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	65162-175-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65162-175-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65162-175-50	`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	65162-175-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65162-175-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65162-175-50	`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	65162-175-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65162-175-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65162-175-50	`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	65162-175-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65162-175-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65162-175-50	`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	65162-175-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65162-175-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65162-175-50	`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	65162-175-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65162-175-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65162-175-50	`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	65162-175-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65162-175-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65162-175-50	`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	65162-175-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65162-175-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65162-175-50	`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	65162-175-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65162-175-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65162-175-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65162-175-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65162-175-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65162-175-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65162-175-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65162-175-11	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65162-175-50	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65162-175-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65162-175-11	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65162-175-50	`1332a3947898…`	`d4bfe170f9cd…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65162-175-10	2021-01-29	C162847	48780-1	97449f38-c24b-f6ea-e053-dbdaa90aa703	Metformin Hydrochloride Tablets, USP
65162-175-11	2021-01-29	C162847	48780-1	97449f38-c24b-f6ea-e053-dbdaa90aa703	Metformin Hydrochloride Tablets, USP
65162-175-50	2021-01-29	C162847	48780-1	97449f38-c24b-f6ea-e053-dbdaa90aa703	Metformin Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-175-10	Metformin Hydrochloride	100 in 1 BOTTLE	TABLET	100	9
65162-175-11	Metformin Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	9
65162-175-50	Metformin Hydrochloride	500 in 1 BOTTLE	TABLET	500	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-175-10	EA - Each	65162-175	e87f4666-3f36-464d-a846-c7a51554a87f	1	2013-02-13
65162-175-11	EA - Each	65162-175	96e4c8b0-1987-4140-ba28-ef12f0353914	1	2013-02-13
65162-175-50	EA - Each	65162-175	6f4ab74e-343c-43c5-a0db-9c04fe40585a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE (METFORMIN) TABLET [AMNEAL PHARMACEUTICALS]	9
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE (METFORMIN) TABLET [AMNEAL PHARMACEUTICALS]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-175	METFORMIN HYDROCHLORIDE (METFORMIN) TABLET [AMNEAL PHARMACEUTICALS]	9	Legacy NDC, 3 package rows	20120907_45cc673a-e125-4d76-8013-89a089eb0ae9.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
9100L32L2N	METFORMIN	657-24-9	Metformin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	45cc673a-e125-4d76-8013-89a089eb0ae9	9
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	45cc673a-e125-4d76-8013-89a089eb0ae9	9
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	45cc673a-e125-4d76-8013-89a089eb0ae9	9
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	45cc673a-e125-4d76-8013-89a089eb0ae9	9
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	45cc673a-e125-4d76-8013-89a089eb0ae9	9
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	45cc673a-e125-4d76-8013-89a089eb0ae9	9
861004	metformin HCl 1 GM Oral Tablet	SY	45cc673a-e125-4d76-8013-89a089eb0ae9	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
65162-175-10	65162017510	100 in 1 BOTTLE	Historical
65162-175-11	65162017511	1000 in 1 BOTTLE	Historical
65162-175-50	65162017550	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride Tablets, USP	Amneal Pharmaceuticals	2012-09-06	HUMAN PRESCRIPTION DRUG LABEL	9