Application 076172

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076172-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL			2004-06-16

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 2 · 43 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
2026-09-14 22:38:34	2026-08	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076172-001	AB1	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A076172-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076172-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076172-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076172-001	AB1	1	`ea99ee380514…`

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 10 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0710e208-5b2c-3c72-e063-6394a90a4dac	2024-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	2024-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	583dac53-65e7-4710-912a-ecd89d07ad03	2024-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	ed6e6f87-ddd7-4c9d-a263-47154d3a9478	2024-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5bb945c1-954a-4d43-aa24-33767d19c57c	2024-08-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	011de1a5-1ac0-4831-9e8d-26ec79ba2205	2024-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	6a9ab61a-a5d0-41ef-b528-59eac6b4cfe6	2024-08-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	a8a10ea0-7aa6-48ab-aad4-af8895636672	2024-08-16		Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	32d6c5f4-0116-4e38-b179-e1967ae63e66	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	4670d280-53c3-4c51-b3c5-26d71e47bddc	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	041632fa-9bf4-8d7c-e063-6294a90adefb	2024-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4a53ea53-3052-614b-e054-00144ff8d46c	2024-07-19	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1ef6c527-89f5-4830-8900-7532b0a7ef26	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Epic Pharma, LLC	a9e7608f-540c-d90c-e053-2a95a90a4f98	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1a047fc0-196e-79af-e063-6394a90a1e0d	2024-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1c046303-993c-4111-ac9a-40a0d97ca6a2	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f6	2024-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	afb183f6-a13c-4f00-82d5-9fe336173d34	2024-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	d5dbf0d9-9673-4aae-9e28-da9b90bac038	2024-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c2783b59-7b20-4d4c-a3ca-03ed60dcf2c3	2024-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-248	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
62037-571	Metformin Hydrochloride	Metformin Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-571	Metformin Hydrochloride	Metformin Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-571	Metformin Hydrochloride	Metformin Hydrochloride	Actavis Pharma, Inc.	ANDA	Current