Riomet

Product NDC: 10631-238
11-digit product format: 106310238
Labeler code: 10631
Product ID: 10631-238_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
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/5mL
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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RIOMET	METFORMIN HYDROCHLORIDE	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11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UTC	2026-02	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`011fe1cb6892…`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of this ZIP	2025-12	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`31067a03dcf5…`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UTC	2025-08	N021591-001	RIOMET	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-11	`6a471c1ec25d…`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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Riomet
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
786Z46389E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861025	Internal RxNorm lookup
861027	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
05d4df4b-dfe8-4828-b423-a3d4f2c4114a	Available on FDA.report

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
10631-238-01	Riomet	118 mL in 1 BOTTLE	SOLUTION	118		11
10631-238-02	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
10631-238-01	ML - Milliliter	10631-238	4efdf8d5-bb49-4a19-9190-7589b5d33c97	1	2014-12-01
10631-238-02	ML - Milliliter	10631-238	022a4426-66eb-450c-94b9-ba2770a947b8	1	2014-12-01

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
10631-238	RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20181211_05d4df4b-dfe8-4828-b423-a3d4f2c4114a.zip

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 ndc (product): 10631-238

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
10631-238-01	10631023801	118 mL in 1 BOTTLE (10631-238-01)	118 ml	2004-01-04	0000-00-00	No	No	Current
10631-238-02	10631023802	473 mL in 1 BOTTLE (10631-238-02)	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