Metformin Hydrochloride

Product NDC: 12634-789
11-digit product format: 126340789
Labeler code: 12634
Product ID: 12634-789_46625c1e-8ee1-4178-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA091184
Marketing category: ANDA
Marketing start: 2011-01-31
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: 2020-12-31
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 · 39 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-789		I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-00	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-01	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-09	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-12	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-18	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-40	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-42	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-45	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-50	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-52	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-54	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-57	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-59	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-60	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-61	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-63	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-66	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-67	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-69	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-71	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-74	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-78	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-79	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-80	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-81	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-82	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-84	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-85	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-90	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-91	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-92	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-93	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-94	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-95	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-96	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-97	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-98	I	Inactivated by FDA	2026-11-10
excluded package	package	12634-789	12634-789-99	I	Inactivated by FDA	2026-11-10

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 11 · 624 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	12634-789-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-789-54	`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	12634-789-74	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-789-96	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A091184-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01
A091184-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01
A091184-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091184-001	AB
A091184-002	AB
A091184-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A091184-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091184-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091184-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091184-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091184-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091184-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091184-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091184-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091184-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091184-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091184-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091184-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091184-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091184-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-001	AB	1	`79d66fd596c7…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-789-00	Metformin Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10	2
12634-789-01	Metformin Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	2
12634-789-09	Metformin Hydrochloride	35 in 1 BOTTLE	TABLET, FILM COATED	35	2
12634-789-12	Metformin Hydrochloride	120 in 1 BOTTLE	TABLET, FILM COATED	120	2
12634-789-18	Metformin Hydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180	2
12634-789-40	Metformin Hydrochloride	40 in 1 BOTTLE	TABLET, FILM COATED	40	2
12634-789-42	Metformin Hydrochloride	42 in 1 BOTTLE	TABLET, FILM COATED	42	2
12634-789-45	Metformin Hydrochloride	45 in 1 BOTTLE	TABLET, FILM COATED	45	2
12634-789-50	Metformin Hydrochloride	50 in 1 BOTTLE	TABLET, FILM COATED	50	2
12634-789-52	Metformin Hydrochloride	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	2
12634-789-54	Metformin Hydrochloride	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	2
12634-789-57	Metformin Hydrochloride	20 in 1 BLISTER PACK	TABLET, FILM COATED	20	2
12634-789-59	Metformin Hydrochloride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	2
12634-789-60	Metformin Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
12634-789-61	Metformin Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	2
12634-789-63	Metformin Hydrochloride	3 in 1 BLISTER PACK	TABLET, FILM COATED	3	2
12634-789-66	Metformin Hydrochloride	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	2
12634-789-67	Metformin Hydrochloride	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	2
12634-789-69	Metformin Hydrochloride	9 in 1 BLISTER PACK	TABLET, FILM COATED	9	2
12634-789-71	Metformin Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
12634-789-74	Metformin Hydrochloride	24 in 1 BOTTLE	TABLET, FILM COATED	24	2
12634-789-78	Metformin Hydrochloride	28 in 1 BOTTLE	TABLET, FILM COATED	28	2
12634-789-79	Metformin Hydrochloride	25 in 1 BOTTLE	TABLET, FILM COATED	25	2
12634-789-80	Metformin Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	2
12634-789-81	Metformin Hydrochloride	21 in 1 BOTTLE	TABLET, FILM COATED	21	2
12634-789-82	Metformin Hydrochloride	12 in 1 BOTTLE	TABLET, FILM COATED	12	2
12634-789-84	Metformin Hydrochloride	14 in 1 BOTTLE	TABLET, FILM COATED	14	2
12634-789-85	Metformin Hydrochloride	15 in 1 BOTTLE	TABLET, FILM COATED	15	2
12634-789-90	Metformin Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	2
12634-789-91	Metformin Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	2
12634-789-92	Metformin Hydrochloride	2 in 1 BOTTLE	TABLET, FILM COATED	2	2
12634-789-93	Metformin Hydrochloride	3 in 1 BOTTLE	TABLET, FILM COATED	3	2
12634-789-94	Metformin Hydrochloride	4 in 1 BOTTLE	TABLET, FILM COATED	4	2
12634-789-95	Metformin Hydrochloride	5 in 1 BOTTLE	TABLET, FILM COATED	5	2
12634-789-96	Metformin Hydrochloride	6 in 1 BOTTLE	TABLET, FILM COATED	6	2
12634-789-97	Metformin Hydrochloride	7 in 1 BOTTLE	TABLET, FILM COATED	7	2
12634-789-98	Metformin Hydrochloride	8 in 1 BOTTLE	TABLET, FILM COATED	8	2
12634-789-99	Metformin Hydrochloride	9 in 1 BOTTLE	TABLET, FILM COATED	9	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-789	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APOTHECA INC.]	2	Legacy NDC, 38 package rows	20170118_4661d307-78b2-2f5b-e054-00144ff88e88.zip

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	4661d307-78b2-2f5b-e054-00144ff88e88	2
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	4661d307-78b2-2f5b-e054-00144ff88e88	2
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	4661d307-78b2-2f5b-e054-00144ff88e88	2
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	4661d307-78b2-2f5b-e054-00144ff88e88	2
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	4661d307-78b2-2f5b-e054-00144ff88e88	2
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	4661d307-78b2-2f5b-e054-00144ff88e88	2
861004	metformin HCl 1 GM Oral Tablet	SY	4661d307-78b2-2f5b-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
12634-789-00	12634078900	10 TABLET, FILM COATED in 1 BOTTLE (12634-789-00)	2011-01-31	0000-00-00	No	No	Current
12634-789-01	12634078901	100 TABLET, FILM COATED in 1 BOTTLE (12634-789-01)	2011-01-31	0000-00-00	No	No	Current
12634-789-09	12634078909	35 TABLET, FILM COATED in 1 BOTTLE (12634-789-09)	2011-01-31	0000-00-00	No	No	Current
12634-789-12	12634078912	120 TABLET, FILM COATED in 1 BOTTLE (12634-789-12)	2011-01-31	0000-00-00	No	No	Current
12634-789-18	12634078918	180 TABLET, FILM COATED in 1 BOTTLE (12634-789-18)	2011-01-31	0000-00-00	No	No	Current
12634-789-40	12634078940	40 TABLET, FILM COATED in 1 BOTTLE (12634-789-40)	2011-01-31	0000-00-00	No	No	Current
12634-789-42	12634078942	42 TABLET, FILM COATED in 1 BOTTLE (12634-789-42)	2011-01-31	0000-00-00	No	No	Current
12634-789-45	12634078945	45 TABLET, FILM COATED in 1 BOTTLE (12634-789-45)	2011-01-31	0000-00-00	No	No	Current
12634-789-50	12634078950	50 TABLET, FILM COATED in 1 BOTTLE (12634-789-50)	2011-01-31	0000-00-00	No	No	Current
12634-789-52	12634078952	12 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-52)	2011-01-31	0000-00-00	No	No	Current
12634-789-54	12634078954	14 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-54)	2011-01-31	0000-00-00	No	No	Current
12634-789-57	12634078957	20 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-57)	2011-01-31	0000-00-00	No	No	Current
12634-789-59	12634078959	30 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-59)	2011-01-31	0000-00-00	No	No	Current
12634-789-60	12634078960	60 TABLET, FILM COATED in 1 BOTTLE (12634-789-60)	2011-01-31	0000-00-00	No	No	Current
12634-789-61	12634078961	10 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-61)	2011-01-31	0000-00-00	No	No	Current
12634-789-63	12634078963	3 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-63)	2011-01-31	0000-00-00	No	No	Current
12634-789-66	12634078966	6 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-66)	2011-01-31	0000-00-00	No	No	Current
12634-789-67	12634078967	7 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-67)	2011-01-31	0000-00-00	No	No	Current
12634-789-69	12634078969	9 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-69)	2011-01-31	0000-00-00	No	No	Current
12634-789-71	12634078971	30 TABLET, FILM COATED in 1 BOTTLE (12634-789-71)	2011-01-31	0000-00-00	No	No	Current
12634-789-74	12634078974	24 TABLET, FILM COATED in 1 BOTTLE (12634-789-74)	2011-01-31	0000-00-00	No	No	Current
12634-789-78	12634078978	28 TABLET, FILM COATED in 1 BOTTLE (12634-789-78)	2011-01-31	0000-00-00	No	No	Current
12634-789-79	12634078979	25 TABLET, FILM COATED in 1 BOTTLE (12634-789-79)	2011-01-31	0000-00-00	No	No	Current
12634-789-80	12634078980	20 TABLET, FILM COATED in 1 BOTTLE (12634-789-80)	2011-01-31	0000-00-00	No	No	Current
12634-789-81	12634078981	21 TABLET, FILM COATED in 1 BOTTLE (12634-789-81)	2011-01-31	0000-00-00	No	No	Current
12634-789-82	12634078982	12 TABLET, FILM COATED in 1 BOTTLE (12634-789-82)	2011-01-31	0000-00-00	No	No	Current
12634-789-84	12634078984	14 TABLET, FILM COATED in 1 BOTTLE (12634-789-84)	2011-01-31	0000-00-00	No	No	Current
12634-789-85	12634078985	15 TABLET, FILM COATED in 1 BOTTLE (12634-789-85)	2011-01-31	0000-00-00	No	No	Current
12634-789-90	12634078990	90 TABLET, FILM COATED in 1 BOTTLE (12634-789-90)	2011-01-31	0000-00-00	No	No	Current
12634-789-91	12634078991	1 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-91)	2011-01-31	0000-00-00	No	No	Current
12634-789-92	12634078992	2 TABLET, FILM COATED in 1 BOTTLE (12634-789-92)	2011-01-31	0000-00-00	No	No	Current
12634-789-93	12634078993	3 TABLET, FILM COATED in 1 BOTTLE (12634-789-93)	2011-01-31	0000-00-00	No	No	Current
12634-789-94	12634078994	4 TABLET, FILM COATED in 1 BOTTLE (12634-789-94)	2011-01-31	0000-00-00	No	No	Current
12634-789-95	12634078995	5 TABLET, FILM COATED in 1 BOTTLE (12634-789-95)	2011-01-31	0000-00-00	No	No	Current
12634-789-96	12634078996	6 TABLET, FILM COATED in 1 BOTTLE (12634-789-96)	2011-01-31	0000-00-00	No	No	Current
12634-789-97	12634078997	7 TABLET, FILM COATED in 1 BOTTLE (12634-789-97)	2011-01-31	0000-00-00	No	No	Current
12634-789-98	12634078998	8 TABLET, FILM COATED in 1 BOTTLE (12634-789-98)	2011-01-31	0000-00-00	No	No	Current
12634-789-99	12634078999	9 TABLET, FILM COATED in 1 BOTTLE (12634-789-99)	2011-01-31	0000-00-00	No	No	Current