metformin hydrochloride

Product NDC: 71205-860
Requested package NDC: 71205-860-55
11-digit product format: 712050860
Labeler code: 71205
Product ID: 71205-860_ef010b85-c2f8-44ca-8042-a10df89dcae3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metformin hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA213247
Marketing category: ANDA
Marketing start: 2021-11-01
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 1000 mg/1
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	71205-860	71205-860-55	D	Discontinued by firm		2026-09-14

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-860	71205-860-55	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-860	71205-860-55	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213247-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL			2021-09-29
A213247-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL			2021-09-29

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 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213247-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213247-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-09-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A213247-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213247-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213247-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213247-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213247-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213247-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213247-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213247-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213247-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213247-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213247-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213247-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213247-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213247-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213247-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213247-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213247-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213247-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213247-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213247-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213247-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213247-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213247-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213247-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213247-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213247-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213247-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213247-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213247-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213247-002	AB2	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213247-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213247-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213247-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213247-002	AB2	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213247-001	AB2	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213247-002	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213247-001	AB2	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213247-002	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213247-001	AB2	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213247-002	AB2	1	`ea1830bbd6c7…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-860-00	EA - Each	71205-860	ce4191c8-27ba-441b-9b0c-3e1a67f816ec	1	2022-07-06
71205-860-30	EA - Each	71205-860	4641d353-1e2d-4358-8107-b21d62a17ad0	1	2022-07-06
71205-860-55	EA - Each	71205-860	b27316ee-a99b-47c0-b0a8-ee191ca5aa57	1	2022-07-06
71205-860-60	EA - Each	71205-860	6dcfb369-6ee1-4e48-a6d6-322e0ead9b6f	1	2022-07-06
71205-860-64	EA - Each	71205-860	9aea49f6-ebff-4dd1-b21a-2f461cbe9e07	1	2022-07-06
71205-860-72	EA - Each	71205-860	58de5f26-3989-4f1f-9184-bc37fc1aae38	1	2022-07-06
71205-860-78	EA - Each	71205-860	58db931b-c740-45c4-a51f-86b78fe4baa4	1	2022-07-06
71205-860-90	EA - Each	71205-860	639b9371-1009-44a7-baae-163ef1b48d5c	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-860	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1	Legacy NDC	20220507_ef010b85-c2f8-44ca-8042-a10df89dcae3.zip

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	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-860-55	71205086055	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-860-55)	2022-05-06	0000-00-00	No	No	Current