Riomet

Product NDC: 10631-206
Requested package NDC: 10631-206-02
11-digit product format: 106310206
Labeler code: 10631
Product ID: 10631-206_8ed86d67-8a49-4334-82c4-1dbf6a489d3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA021591
Marketing category: NDA
Marketing start: 2004-01-04
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	10631-206	10631-206-02	D	Discontinued by firm		2026-11-13

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RIOMET	METFORMIN HYDROCHLORIDE	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11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

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10631-206-01	Riomet	118 mL in 1 BOTTLE	SOLUTION	118		11
10631-206-02	Riomet	473 mL in 1 BOTTLE	SOLUTION	473		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10631-206-01	ML - Milliliter	10631-206	ca96b1cc-e77a-4e47-b041-9eab150ed3c7	1	2012-07-24
10631-206-02	ML - Milliliter	10631-206	788efa7a-d4bc-4c44-aa07-b693457e6042	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES INC.]	5
METFORMIN	ACTIVE MOIETY	9100L32L2N	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES INC.]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES INC.]	5
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES INC.]	5
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES INC.]	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES INC.]	5
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES INC.]	5
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10631-206	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	11	Legacy NDC, 2 package rows	20181211_05d4df4b-dfe8-4828-b423-a3d4f2c4114a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861025	metFORMIN HCl 500 MG in 5 mL Oral Solution	PSN	05d4df4b-dfe8-4828-b423-a3d4f2c4114a	11
861027	Riomet 500 MG in 5 mL Oral Solution	PSN	05d4df4b-dfe8-4828-b423-a3d4f2c4114a	11
861027	metformin hydrochloride 100 MG/ML Oral Solution [Riomet]	SBD	05d4df4b-dfe8-4828-b423-a3d4f2c4114a	11
861025	metformin hydrochloride 100 MG/ML Oral Solution	SCD	05d4df4b-dfe8-4828-b423-a3d4f2c4114a	11
861025	metformin hydrochloride 500 MG per 5 ML Oral Solution	SY	05d4df4b-dfe8-4828-b423-a3d4f2c4114a	11
861027	Riomet 100 MG/ML Oral Solution	SY	05d4df4b-dfe8-4828-b423-a3d4f2c4114a	11
861027	Riomet 500 MG per 5 ML Oral Solution	SY	05d4df4b-dfe8-4828-b423-a3d4f2c4114a	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10631-206-02	10631020602	473 mL in 1 BOTTLE (10631-206-02)	473 ml	2004-01-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Riomet	Sun Pharmaceutical Industries, Inc. \| Mikart, Inc. \| Mikart, LLC. \| Farmhispania S.A.	2018-12-06	HUMAN PRESCRIPTION DRUG LABEL	11