Metformin Hydrochloride

Product NDC: 71800-008
11-digit product format: 718000008
Labeler code: 71800
Product ID: 71800-008_cecd8a68-5f35-3bbb-e053-2995a90a1060
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: INNOVIDA PHARMACEUTIQUE CORPORATION
Application: NDA021591
Marketing category: NDA
Marketing start: 2018-01-10
Marketing end: 2021-11-30
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/5mL
Pharmacologic classes: Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	71800-008		D	Discontinued by firm		2026-08-07
excluded package	package	71800-008	71800-008-01	D	Discontinued by firm		2026-08-07

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 · 24 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	71800-008-01	`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	71800-008-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71800-008-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71800-008-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71800-008-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71800-008-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71800-008-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71800-008-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71800-008-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71800-008-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71800-008-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71800-008-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 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
2026-02-19 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…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL		RLD	2003-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021591-001	RIOMET	500MG/5ML	SOLUTION / ORAL	AB	RLD, RS	2003-09-11	`cb3db0bc1861…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71800-008-01	ML - Milliliter	71800-008	94e4b81b-546b-466d-9bb4-80d9c7b59704	1	2018-09-05

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Riomet	METFORMIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	05d4df4b-dfe8-4828-b423-a3d4f2c4114a	2018-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021591 application number: NDA021591

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71800-008-01	71800000801	473 mL in 1 BOTTLE (71800-008-01)	473 ml	2018-01-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride	INNOVIDA PHARMACEUTIQUE CORPORATION \| Sun Pharmaceutical Industries, Inc. \| Mikart, Inc.	2021-10-20	HUMAN PRESCRIPTION DRUG LABEL	7