METFORMIN HYDROCHLORIDE

Product NDC: 61919-397
11-digit product format: 619190397
Labeler code: 61919
Product ID: 61919-397_d61c9287-d642-87c7-e053-2995a90a67a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METFORMIN HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Direct Rx
Application: ANDA090564
Marketing category: ANDA
Marketing start: 2014-01-01
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-397		I	Inactivated by FDA	2026-10-05
excluded product	product	61919-397		I	Inactivated by FDA	2026-10-05
excluded package	package	61919-397	61919-397-30	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-397	61919-397-60	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-397	61919-397-82	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-397	61919-397-90	I	Inactivated by FDA	2026-10-05

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 · 82 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-397-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-397-82	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-397-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-397-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-397-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-397-82	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-397-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-397-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-397-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-397-82	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-397-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-397-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-397-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-397-82	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-397-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-397-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-397-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-397-82	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-397-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-397-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-397-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-397-82	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-397-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-397-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-397-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-397-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-397-82	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-397-90	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-397-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-397-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-397-82	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-397-90	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-397-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-397-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-397-82	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-397-90	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-397-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-397-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-397-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090564-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090564-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090564-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090564-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090564-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090564-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-397-60	2025-01-30	2cef2736-96bd-d83d-e063-dadaa90ab31f	METFORMIN HYDROCHLORIDE
61919-397-82	2025-01-30	2cef2736-96bd-d83d-e063-dadaa90ab31f	METFORMIN HYDROCHLORIDE
61919-397-90	2025-01-30	2cef2736-96bd-d83d-e063-dadaa90ab31f	METFORMIN HYDROCHLORIDE
61919-397-30	2020-01-31	9d75b9cf-de05-f424-e053-dadaa90a57ce	METFORMIN HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-397-60	METFORMIN HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60	9
61919-397-82	METFORMIN HYDROCHLORIDE	180 in 1 BOTTLE	TABLET	180	9
61919-397-90	METFORMIN HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	9
61919-397-30	METFORMIN HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-397-30	EA - Each	61919-397	dc8c6ed1-4c6f-43c1-8473-04312f75303a	1	2019-09-05
61919-397-60	EA - Each	61919-397	7506ce8d-777d-4ed5-bd12-5afa50434165	1	2016-11-08
61919-397-82	EA - Each	61919-397	4af515ee-11ea-4f5a-95b3-50508d0cbd9a	1	2019-12-10
61919-397-90	EA - Each	61919-397	a69e612c-f6f4-44f5-913e-43ca38fa806d	1	2019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1
BLACKBERRY	INACTIVE INGREDIENT	8A6OMU3I8L	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-397	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	9	Legacy NDC, 3 package rows	20230420_281e6da6-21e0-61eb-e054-00144ff8d46c.zip
61919-397	METFORMIN HYDROCHLORIDE TABLET [DIRECT RX]	2	Legacy NDC, 1 package rows	20161014_1c565afb-dfea-4eff-8bbe-8561d1d03545.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 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin HCl	METFORMIN HCL	Unit Dose Solutions, Inc.	5538e9df-0983-9281-e063-6394a90a9249	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	PD-Rx Pharmaceuticals, Inc.	c8e50300-1838-4c51-8d9d-ebbaaf0f3991	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	59a4ccda-5487-4ac4-9373-0c0fc8b7c88b	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
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 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

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	281e6da6-21e0-61eb-e054-00144ff8d46c	9
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	281e6da6-21e0-61eb-e054-00144ff8d46c	9
861004	metformin HCl 1 GM Oral Tablet	SY	281e6da6-21e0-61eb-e054-00144ff8d46c	9
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	1c565afb-dfea-4eff-8bbe-8561d1d03545	2
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	1c565afb-dfea-4eff-8bbe-8561d1d03545	2
861004	metformin HCl 1 GM Oral Tablet	SY	1c565afb-dfea-4eff-8bbe-8561d1d03545	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-397-30	61919039730	30 in 1 BOTTLE						Historical
61919-397-60	61919039760	60 TABLET in 1 BOTTLE (61919-397-60)	60 tablet	2015-01-01	0000-00-00	No	No	Current
61919-397-82	61919039782	180 TABLET in 1 BOTTLE (61919-397-82)	180 tablet	2014-01-01	0000-00-00	No	No	Current
61919-397-90	61919039790	90 TABLET in 1 BOTTLE (61919-397-90)	90 tablet	2014-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE	Direct Rx	2023-04-19	HUMAN PRESCRIPTION DRUG LABEL	9
METFORMIN HYDROCHLORIDE	Direct Rx	2016-07-07	HUMAN PRESCRIPTION DRUG LABEL	2