Application 021591

Type: NDA
Sponsor: RANBAXY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIOMET	METFORMIN HYDROCHLORIDE	SOLUTION;ORAL	500MG/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
N021591-001	RIOMET	METFORMIN HYDROCHLORIDE	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11

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 · 45 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
2026-11-14 07:37:17	2026-10	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD, RS	2003-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD, RS	2003-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD, RS	2003-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD, RS	2003-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021591-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021591-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021591-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021591-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021591-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021591-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021591-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021591-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021591-001	AB	1	`c0c555d07b60…`
2022-10-28 04:53 UTC	2022-10	N021591-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021591-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021591-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021591-001	6890957	2021-08-07	Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021591-001	6890957	2021-08-07	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021591-001	6890957	2021-08-07	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021591-001	6890957	2021-08-07	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021591-001	6890957	2021-08-07	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021591-001	6890957	2021-08-07	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021591-001	6890957	2021-08-07	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021591-001	6890957	2021-08-07	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021591-001	6890957	2021-08-07	Drug product	`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 4 of 12 · 233 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	836f3647-bfef-40d1-b475-c0d240241a67	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	1e7ab8da-4ece-499c-b0fb-34e37d991c1c	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	1cb2b2be-595c-4e72-8d2c-c1edc7f85682	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	UNICHEM PHARMACEUTICALS (USA), INC.	93c8deae-3103-4cbf-a5d1-fe0d37e76df8	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	be023bca-511e-4801-bd2b-e30dd1408772	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	51285096-e2ce-0f3c-e063-6394a90a35d4	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Granules Pharmaceuticals Inc.	2387a618-24d8-4813-aa83-9114edb35374	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0448c618-2f0d-4ed3-866f-74b413cf902d	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	60142fb2-16da-4f54-a542-74f9a70b9c8b	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	388ee1e0-a0d2-324d-e063-6394a90a1664	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Oral Solution	METFORMIN HYDROCHLORIDE	MICRO LABS LIMITED	fb90693a-074a-45be-94f4-ed6298b1f4e4	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	abd0dad9-5f29-4102-a099-dce7bdddb98b	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	b51da8d7-ab4a-4c40-97c9-88bd379366d1	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	direct rx	c33e24e9-0441-6b94-e053-2a95a90a9c68	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	75b25738-31e6-4b58-9d2b-f4a1ab4ab090	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Oral Solution	METFORMIN HYDROCHLORIDE	Bionpharma Inc.,	3ab005d4-bc99-4fdb-e063-6394a90a5124	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Method Pharmaceuticals, LLC.	4aa880a4-7ec0-9155-e063-6394a90a8f3e	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	239834b0-121a-4903-b3ee-90bb4db4753b	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	5f2023d2-05ae-489d-9e18-fb75057496bc	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1d7556eb-82b4-4085-b0b1-dc061b216feb	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback 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
10631-206	Riomet	Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-238	Riomet	Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	NDA	Current
71800-008	Metformin Hydrochloride	Metformin Hydrochloride	INNOVIDA PHARMACEUTIQUE CORPORATION	NDA	Current
71800-008	Metformin Hydrochloride	Metformin Hydrochloride	INNOVIDA PHARMACEUTIQUE CORPORATION	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56454	SUPPL	2018-11-15
56383	SUPPL	2018-11-08
47952	SUPPL	2017-04-12
47926	SUPPL	2017-04-11
28212	SUPPL	2010-12-10
37307	SUPPL	2010-12-06
37306	SUPPL	2008-11-07
5815	SUPPL	2008-10-23
28211	SUPPL	2005-10-20
37305	SUPPL	2005-09-30
42225	ORIG	2005-01-11
15844	SUPPL	2004-06-07
5814	SUPPL	2004-06-07
37304	ORIG	2003-09-26
5813	ORIG	2003-09-25