Metformin Hydrochloride

Product NDC: 72789-059
11-digit product format: 727890059
Labeler code: 72789
Product ID: 72789-059_e725dbb0-9483-55d0-e053-2a95a90ad01d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA078321
Marketing category: ANDA
Marketing start: 2008-04-17
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 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	72789-059		D	Discontinued by firm	2026-10-12
excluded package	package	72789-059	72789-059-30	D	Discontinued by firm	2026-10-12
excluded package	package	72789-059	72789-059-60	D	Discontinued by firm	2026-10-12
excluded package	package	72789-059	72789-059-90	D	Discontinued by firm	2026-10-12
excluded package	package	72789-059	72789-059-93	D	Discontinued by firm	2026-10-12
excluded package	package	72789-059	72789-059-98	D	Discontinued by firm	2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 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	72789-059-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72789-059-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72789-059-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72789-059-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72789-059-30	`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	72789-059-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72789-059-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72789-059-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72789-059-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72789-059-30	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078321-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-04-17
A078321-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078321-001	AB1
A078321-002	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 2 of 3 · 86 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
2022-03-09 01:35 UTC	2022-03	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A078321-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078321-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078321-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078321-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078321-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078321-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078321-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078321-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078321-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078321-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078321-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078321-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078321-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078321-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078321-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078321-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078321-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078321-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-059-30	EA - Each	72789-059	63ccdd5e-1a5f-4f2e-8603-a4b03bfd2592	1	2020-07-13
72789-059-60	EA - Each	72789-059	04ab1455-27bb-4c46-9aa5-a441c46ae9c3	1	2020-04-20
72789-059-90	EA - Each	72789-059	6ba25511-287a-4d34-9fd4-389fffb3d443	1	2020-04-20
72789-059-93	EA - Each	72789-059	1c933c34-074e-4daf-9afa-0fbb7d3c44ba	1	2020-07-13
72789-059-98	EA - Each	72789-059	d6a1b3ae-53c6-47b7-ba1f-93603b91a219	1	2022-10-06

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	6f6118c1-cecc-4d7b-9965-7b114a1ad56b	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-059-30	72789005930	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-30)	2020-05-27	0000-00-00	No	No	Current
72789-059-60	72789005960	60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-60)	2020-03-02	0000-00-00	No	No	Current
72789-059-90	72789005990	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-90)	2020-03-02	0000-00-00	No	No	Current
72789-059-93	72789005993	180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-93)	2020-05-05	0000-00-00	No	No	Current
72789-059-98	72789005998	120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-98)	2022-08-26	0000-00-00	No	No	Current