Metformin Hydrochloride

Product NDC: 0591-2719
11-digit product format: 005912719
Labeler code: 0591
Product ID: 0591-2719_ba0272a1-f364-42bf-a536-f3fdd4caee48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: NDA021574
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-04-18
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0591-2719		D	Discontinued by firm		2026-08-17
excluded package	package	0591-2719	0591-2719-60	D	Discontinued by firm		2026-08-17

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 · 4 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	0591-2719-60	`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	0591-2719-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021574-001	FORTAMET	METFORMIN HYDROCHLORIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27
N021574-002	FORTAMET	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27

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 3 · 84 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
2026-08-18 06:07:40	2026-07	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021574-002	FORTAMET	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021574-002	FORTAMET	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021574-001	FORTAMET	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021574-002	FORTAMET	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021574-001	FORTAMET	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021574-002	FORTAMET	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021574-001	FORTAMET	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021574-002	FORTAMET	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	2004-04-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021574-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021574-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021574-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021574-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021574-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021574-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021574-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021574-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021574-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021574-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021574-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021574-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021574-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021574-002	AB2	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021574-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021574-002	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021574-002	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021574-002	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021574-002	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021574-002	AB2	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021574-002	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021574-002	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021574-002	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021574-002	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021574-002	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021574-002	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021574-002	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021574-002	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021574-002	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021574-002	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021574-002	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021574-002	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021574-002	AB2	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021574-001	6790459	2021-03-17	U-604		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021574-001	6866866	2021-03-17		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021574-002	6790459	2021-03-17	U-604		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021574-002	6866866	2021-03-17		Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021574-001	6790459	2021-03-17	U-604		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021574-001	6866866	2021-03-17		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021574-002	6790459	2021-03-17	U-604		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021574-002	6866866	2021-03-17		Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021574-001	6790459	2021-03-17	U-604		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021574-001	6866866	2021-03-17		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021574-002	6790459	2021-03-17	U-604		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021574-002	6866866	2021-03-17		Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021574-001	6790459	2021-03-17	U-604		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021574-001	6866866	2021-03-17		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021574-002	6790459	2021-03-17	U-604		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021574-002	6866866	2021-03-17		Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021574-001	6790459	2021-03-17	U-604		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021574-001	6866866	2021-03-17		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021574-002	6790459	2021-03-17	U-604		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021574-002	6866866	2021-03-17		Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021574-001	6790459	2021-03-17	U-604		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021574-001	6866866	2021-03-17		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021574-002	6790459	2021-03-17	U-604		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021574-002	6866866	2021-03-17		Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021574-001	6790459	2021-03-17	U-604		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021574-001	6866866	2021-03-17		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021574-002	6790459	2021-03-17	U-604		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021574-002	6866866	2021-03-17		Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021574-001	6790459	2021-03-17	U-604		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021574-001	6866866	2021-03-17		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021574-002	6790459	2021-03-17	U-604		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021574-002	6866866	2021-03-17		Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021574-001	6790459	2021-03-17	U-604		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021574-001	6866866	2021-03-17		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021574-002	6790459	2021-03-17	U-604		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021574-002	6866866	2021-03-17		Drug product	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2719-60	EA - Each	0591-2719	24ab58aa-e5ae-4ab5-b92b-baed3cf1ad74	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2719	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	10	Legacy NDC	20190116_5c59e295-8529-4402-81f7-d86047fde848.zip

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
0591-2719-60	00591271960	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2719-60)	2012-04-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride	Actavis Pharma, Inc. \| Actavis Laboratories FL, Inc.	2018-11-30	HUMAN PRESCRIPTION DRUG LABEL	10