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RIOMET	METFORMIN HYDROCHLORIDE	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11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N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`d4dbc9d85df4…`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N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`c2088c7a36db…`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N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`84e616aacf4f…`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N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`caaa826d4ba7…`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UTC	2026-02	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`011fe1cb6892…`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 9 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	A-S Medication Solutions	2d2ebf52-3d5e-4fad-b7f7-c9280957574c	2024-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Oceanside Pharmaceuticals	74d32a8a-c4c2-4dbb-b376-eea3f8fa64d7	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c2bbaa0c-5b05-4335-882f-14f1b443edd7	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	54ca16e6-1213-4877-8ace-477c764c8e76	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	242538d7-fb79-4df6-e063-6394a90a5b96	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	American Health Packaging	dd54d30b-9390-4e5a-bf62-fbf18b91e4cd	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0710e208-5b2c-3c72-e063-6394a90a4dac	2024-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 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 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 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 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 generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	a8a10ea0-7aa6-48ab-aad4-af8895636672	2024-08-16		Name fallback 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 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 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 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 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 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