Metformin Hydrochloride

Product NDC: 12634-757
11-digit product format: 126340757
Labeler code: 12634
Product ID: 12634-757_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: 850 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	12634-757		I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-00	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-01	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-09	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-12	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-18	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-40	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-42	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-45	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-50	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-52	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-54	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-57	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-59	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-60	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-61	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-63	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-66	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-67	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-69	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-71	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-74	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-78	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-79	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-80	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-81	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-82	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-84	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-85	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-90	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-91	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-92	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-93	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-94	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-95	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-96	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-97	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-98	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-757	12634-757-99	I	Inactivated by FDA	2026-08-10

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	12634-757-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-757-94	`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	12634-757-97	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-757-45	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	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 · 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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091184-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091184-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091184-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091184-001	AB	1	`8072bd15b7f6…`

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, Related label table
NDC	Related label
12634-757-00	Metformin Hydrochloride Tablets USP
12634-757-01	Metformin Hydrochloride Tablets USP
12634-757-09	Metformin Hydrochloride Tablets USP
12634-757-12	Metformin Hydrochloride Tablets USP
12634-757-18	Metformin Hydrochloride Tablets USP
12634-757-40	Metformin Hydrochloride Tablets USP
12634-757-42	Metformin Hydrochloride Tablets USP
12634-757-45	Metformin Hydrochloride Tablets USP
12634-757-50	Metformin Hydrochloride Tablets USP
12634-757-52	Metformin Hydrochloride Tablets USP
12634-757-54	Metformin Hydrochloride Tablets USP
12634-757-57	Metformin Hydrochloride Tablets USP
12634-757-59	Metformin Hydrochloride Tablets USP
12634-757-60	Metformin Hydrochloride Tablets USP
12634-757-61	Metformin Hydrochloride Tablets USP
12634-757-63	Metformin Hydrochloride Tablets USP
12634-757-66	Metformin Hydrochloride Tablets USP
12634-757-67	Metformin Hydrochloride Tablets USP
12634-757-69	Metformin Hydrochloride Tablets USP
12634-757-71	Metformin Hydrochloride Tablets USP
12634-757-74	Metformin Hydrochloride Tablets USP
12634-757-78	Metformin Hydrochloride Tablets USP
12634-757-79	Metformin Hydrochloride Tablets USP
12634-757-80	Metformin Hydrochloride Tablets USP
12634-757-81	Metformin Hydrochloride Tablets USP
12634-757-82	Metformin Hydrochloride Tablets USP
12634-757-84	Metformin Hydrochloride Tablets USP
12634-757-85	Metformin Hydrochloride Tablets USP
12634-757-90	Metformin Hydrochloride Tablets USP
12634-757-91	Metformin Hydrochloride Tablets USP
12634-757-92	Metformin Hydrochloride Tablets USP
12634-757-93	Metformin Hydrochloride Tablets USP
12634-757-94	Metformin Hydrochloride Tablets USP
12634-757-95	Metformin Hydrochloride Tablets USP
12634-757-96	Metformin Hydrochloride Tablets USP
12634-757-97	Metformin Hydrochloride Tablets USP
12634-757-98	Metformin Hydrochloride Tablets USP
12634-757-99	Metformin Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-757-00	Metformin Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10	2
12634-757-01	Metformin Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	2
12634-757-09	Metformin Hydrochloride	35 in 1 BOTTLE	TABLET, FILM COATED	35	2
12634-757-12	Metformin Hydrochloride	120 in 1 BOTTLE	TABLET, FILM COATED	120	2
12634-757-18	Metformin Hydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180	2
12634-757-40	Metformin Hydrochloride	40 in 1 BOTTLE	TABLET, FILM COATED	40	2
12634-757-42	Metformin Hydrochloride	42 in 1 BOTTLE	TABLET, FILM COATED	42	2
12634-757-45	Metformin Hydrochloride	45 in 1 BOTTLE	TABLET, FILM COATED	45	2
12634-757-50	Metformin Hydrochloride	50 in 1 BOTTLE	TABLET, FILM COATED	50	2
12634-757-52	Metformin Hydrochloride	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	2
12634-757-54	Metformin Hydrochloride	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	2
12634-757-57	Metformin Hydrochloride	20 in 1 BLISTER PACK	TABLET, FILM COATED	20	2
12634-757-59	Metformin Hydrochloride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	2
12634-757-60	Metformin Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
12634-757-61	Metformin Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	2
12634-757-63	Metformin Hydrochloride	3 in 1 BLISTER PACK	TABLET, FILM COATED	3	2
12634-757-66	Metformin Hydrochloride	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	2
12634-757-67	Metformin Hydrochloride	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	2
12634-757-69	Metformin Hydrochloride	9 in 1 BLISTER PACK	TABLET, FILM COATED	9	2
12634-757-71	Metformin Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
12634-757-74	Metformin Hydrochloride	24 in 1 BOTTLE	TABLET, FILM COATED	24	2
12634-757-78	Metformin Hydrochloride	28 in 1 BOTTLE	TABLET, FILM COATED	28	2
12634-757-79	Metformin Hydrochloride	25 in 1 BOTTLE	TABLET, FILM COATED	25	2
12634-757-80	Metformin Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	2
12634-757-81	Metformin Hydrochloride	21 in 1 BOTTLE	TABLET, FILM COATED	21	2
12634-757-82	Metformin Hydrochloride	12 in 1 BOTTLE	TABLET, FILM COATED	12	2
12634-757-84	Metformin Hydrochloride	14 in 1 BOTTLE	TABLET, FILM COATED	14	2
12634-757-85	Metformin Hydrochloride	15 in 1 BOTTLE	TABLET, FILM COATED	15	2
12634-757-90	Metformin Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	2
12634-757-91	Metformin Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	2
12634-757-92	Metformin Hydrochloride	2 in 1 BOTTLE	TABLET, FILM COATED	2	2
12634-757-93	Metformin Hydrochloride	3 in 1 BOTTLE	TABLET, FILM COATED	3	2
12634-757-94	Metformin Hydrochloride	4 in 1 BOTTLE	TABLET, FILM COATED	4	2
12634-757-95	Metformin Hydrochloride	5 in 1 BOTTLE	TABLET, FILM COATED	5	2
12634-757-96	Metformin Hydrochloride	6 in 1 BOTTLE	TABLET, FILM COATED	6	2
12634-757-97	Metformin Hydrochloride	7 in 1 BOTTLE	TABLET, FILM COATED	7	2
12634-757-98	Metformin Hydrochloride	8 in 1 BOTTLE	TABLET, FILM COATED	8	2
12634-757-99	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
12634-757	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APOTHECA INC.]	2	Legacy NDC, 38 package rows	20170118_4661d307-78b2-2f5b-e054-00144ff88e88.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	0ff1ba75-3c86-4baf-a6b1-1bb883839866	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091184 application number: ANDA091184

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
12634-757-00	12634075700	10 TABLET, FILM COATED in 1 BOTTLE (12634-757-00)	2011-01-31	0000-00-00	No	No	Current
12634-757-01	12634075701	100 TABLET, FILM COATED in 1 BOTTLE (12634-757-01)	2011-01-31	0000-00-00	No	No	Current
12634-757-09	12634075709	35 TABLET, FILM COATED in 1 BOTTLE (12634-757-09)	2011-01-31	0000-00-00	No	No	Current
12634-757-12	12634075712	120 TABLET, FILM COATED in 1 BOTTLE (12634-757-12)	2011-01-31	0000-00-00	No	No	Current
12634-757-18	12634075718	180 TABLET, FILM COATED in 1 BOTTLE (12634-757-18)	2011-01-31	0000-00-00	No	No	Current
12634-757-40	12634075740	40 TABLET, FILM COATED in 1 BOTTLE (12634-757-40)	2011-01-31	0000-00-00	No	No	Current
12634-757-42	12634075742	42 TABLET, FILM COATED in 1 BOTTLE (12634-757-42)	2011-01-31	0000-00-00	No	No	Current
12634-757-45	12634075745	45 TABLET, FILM COATED in 1 BOTTLE (12634-757-45)	2011-01-31	0000-00-00	No	No	Current
12634-757-50	12634075750	50 TABLET, FILM COATED in 1 BOTTLE (12634-757-50)	2011-01-31	0000-00-00	No	No	Current
12634-757-52	12634075752	12 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-52)	2011-01-31	0000-00-00	No	No	Current
12634-757-54	12634075754	14 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-54)	2011-01-31	0000-00-00	No	No	Current
12634-757-57	12634075757	20 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-57)	2011-01-31	0000-00-00	No	No	Current
12634-757-59	12634075759	30 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-59)	2011-01-31	0000-00-00	No	No	Current
12634-757-60	12634075760	60 TABLET, FILM COATED in 1 BOTTLE (12634-757-60)	2011-01-31	0000-00-00	No	No	Current
12634-757-61	12634075761	10 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-61)	2011-01-31	0000-00-00	No	No	Current
12634-757-63	12634075763	3 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-63)	2011-01-31	0000-00-00	No	No	Current
12634-757-66	12634075766	6 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-66)	2011-01-31	0000-00-00	No	No	Current
12634-757-67	12634075767	7 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-67)	2011-01-31	0000-00-00	No	No	Current
12634-757-69	12634075769	9 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-69)	2011-01-31	0000-00-00	No	No	Current
12634-757-71	12634075771	30 TABLET, FILM COATED in 1 BOTTLE (12634-757-71)	2011-01-31	0000-00-00	No	No	Current
12634-757-74	12634075774	24 TABLET, FILM COATED in 1 BOTTLE (12634-757-74)	2011-01-31	0000-00-00	No	No	Current
12634-757-78	12634075778	28 TABLET, FILM COATED in 1 BOTTLE (12634-757-78)	2011-01-31	0000-00-00	No	No	Current
12634-757-79	12634075779	25 TABLET, FILM COATED in 1 BOTTLE (12634-757-79)	2011-01-31	0000-00-00	No	No	Current
12634-757-80	12634075780	20 TABLET, FILM COATED in 1 BOTTLE (12634-757-80)	2011-01-31	0000-00-00	No	No	Current
12634-757-81	12634075781	21 TABLET, FILM COATED in 1 BOTTLE (12634-757-81)	2011-01-31	0000-00-00	No	No	Current
12634-757-82	12634075782	12 TABLET, FILM COATED in 1 BOTTLE (12634-757-82)	2011-01-31	0000-00-00	No	No	Current
12634-757-84	12634075784	14 TABLET, FILM COATED in 1 BOTTLE (12634-757-84)	2011-01-31	0000-00-00	No	No	Current
12634-757-85	12634075785	15 TABLET, FILM COATED in 1 BOTTLE (12634-757-85)	2011-01-31	0000-00-00	No	No	Current
12634-757-90	12634075790	90 TABLET, FILM COATED in 1 BOTTLE (12634-757-90)	2011-01-31	0000-00-00	No	No	Current
12634-757-91	12634075791	1 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-91)	2011-01-31	0000-00-00	No	No	Current
12634-757-92	12634075792	2 TABLET, FILM COATED in 1 BOTTLE (12634-757-92)	2011-01-31	0000-00-00	No	No	Current
12634-757-93	12634075793	3 TABLET, FILM COATED in 1 BOTTLE (12634-757-93)	2011-01-31	0000-00-00	No	No	Current
12634-757-94	12634075794	4 TABLET, FILM COATED in 1 BOTTLE (12634-757-94)	2011-01-31	0000-00-00	No	No	Current
12634-757-95	12634075795	5 TABLET, FILM COATED in 1 BOTTLE (12634-757-95)	2011-01-31	0000-00-00	No	No	Current
12634-757-96	12634075796	6 TABLET, FILM COATED in 1 BOTTLE (12634-757-96)	2011-01-31	0000-00-00	No	No	Current
12634-757-97	12634075797	7 TABLET, FILM COATED in 1 BOTTLE (12634-757-97)	2011-01-31	0000-00-00	No	No	Current
12634-757-98	12634075798	8 TABLET, FILM COATED in 1 BOTTLE (12634-757-98)	2011-01-31	0000-00-00	No	No	Current
12634-757-99	12634075799	9 TABLET, FILM COATED in 1 BOTTLE (12634-757-99)	2011-01-31	0000-00-00	No	No	Current