Metformin Hydrochloride Oral Solution

Product NDC: 42571-360
11-digit product format: 425710360
Labeler code: 42571
Product ID: 42571-360_4d2a345b-54cc-2188-e063-6294a90ac6bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: MICRO LABS LIMITED
Application: ANDA211309
Marketing category: ANDA
Marketing start: 2020-04-20
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/5mL
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A211309-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A211309-001	AB

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.

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	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB		2020-03-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211309-001	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION / ORAL	AB	RS	2020-03-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211309-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211309-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211309-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211309-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211309-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211309-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211309-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211309-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211309-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211309-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211309-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211309-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211309-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211309-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211309-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211309-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211309-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211309-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211309-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211309-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211309-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211309-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211309-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211309-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211309-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211309-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211309-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211309-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211309-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211309-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211309-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211309-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211309-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211309-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211309-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211309-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211309-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metformin Hydrochloride Oral Solution
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861025	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
fb90693a-074a-45be-94f4-ed6298b1f4e4	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42571-360-07	2026-01-29	C162847	48780-1	49896155-d817-586f-e063-e6dba90add90	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE ORAL SOLUTION. METFORMIN HYDROCHLORIDE oral solution Initial U.S. Approval: 1995
42571-360-10	2026-01-29	C162847	48780-1	49896155-d817-586f-e063-e6dba90add90	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE ORAL SOLUTION. METFORMIN HYDROCHLORIDE oral solution Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42571-360-07	Metformin Hydrochloride Oral Solution	473 mL in 1 BOTTLE	SOLUTION	473		5
42571-360-10	Metformin Hydrochloride Oral Solution	118 mL in 1 BOTTLE	SOLUTION	118		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-360-07	ML - Milliliter	42571-360	abe8c67e-6c79-4524-853b-fd213016c4a6	1	2020-05-08
42571-360-10	ML - Milliliter	42571-360	f97d8b81-46e3-45fa-a36b-9c13d4fdde85	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-360	METFORMIN HYDROCHLORIDE ORAL SOLUTION (METFORMIN HYDROCHLORIDE) SOLUTION [MICRO LABS LIMITED]	3	Current NDC, Legacy NDC, 2 package rows	20241228_fb90693a-074a-45be-94f4-ed6298b1f4e4.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride Oral Solution	METFORMIN HYDROCHLORIDE	MICRO LABS LIMITED	fb90693a-074a-45be-94f4-ed6298b1f4e4	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211309 application number: ANDA211309 ndc (product): 42571-360
Metformin Hydrochloride Oral Solution	METFORMIN HYDROCHLORIDE	TRUPHARMA, LLC	73691c6c-8841-4c5d-b4a5-c3ed3b5effa1	2024-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211309 application number: ANDA211309
Metformin Hydrochloride Oral Solution	METFORMIN HYDROCHLORIDE	Saptalis Pharmaceuticals, LLC.	df61d56e-18ff-404c-b671-42b39aa23574	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211309 application number: ANDA211309

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	fb90693a-074a-45be-94f4-ed6298b1f4e4	5
861025	metformin hydrochloride 100 MG/ML Oral Solution	SCD	fb90693a-074a-45be-94f4-ed6298b1f4e4	5
861025	metformin hydrochloride 500 MG per 5 ML Oral Solution	SY	fb90693a-074a-45be-94f4-ed6298b1f4e4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-360-07	42571036007	473 mL in 1 BOTTLE (42571-360-07)	473 ml	2020-04-20	0000-00-00	No	No	Current
42571-360-10	42571036010	118 mL in 1 BOTTLE (42571-360-10)	118 ml	2020-04-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride Oral Solution	MICRO LABS LIMITED \| Saptalis Pharmaceuticals, LLC	2026-03-16	HUMAN PRESCRIPTION DRUG LABEL	5
Metformin Hydrochloride Oral Solution	Bryant Ranch Prepack	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	100
Metformin Hydrochloride Oral Solution	Bryant Ranch Prepack	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	100