Metformin Hydrochloride Oral Solution

Product NDC: 52817-822
Requested package NDC: 52817-822-50
11-digit product format: 528170822
Labeler code: 52817
Product ID: 52817-822_e711470b-ad0e-495d-94ae-04c283dfd493
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: TRUPHARMA, LLC
Application: ANDA211309
Marketing category: ANDA
Marketing start: 2022-01-25
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: 2023-12-31
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	52817-822	52817-822-50	D	Discontinued by firm		2026-08-11

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52817-822-50	52817082250	5 TRAY in 1 CASE (52817-822-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE	5 tray	2022-01-25	0000-00-00	No	No	Current