Metformin Hydrochloride

Product NDC: 42571-333
11-digit product format: 425710333
Labeler code: 42571
Product ID: 42571-333_5ecf7be6-d5f5-a2e8-e063-6394a90a63b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA212448
Marketing category: ANDA
Marketing start: 2023-03-01
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
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 44.

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
A212448-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2023-01-10
A212448-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3		2023-01-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212448-001	AB3
A212448-002	AB3

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 · 54 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
2026-10-15 13:18:30	2026-09	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212448-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212448-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2023-01-10	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A212448-001	AB3	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212448-002	AB3	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212448-001	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212448-002	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212448-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212448-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212448-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212448-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212448-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212448-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212448-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212448-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212448-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212448-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212448-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212448-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212448-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212448-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212448-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212448-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212448-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212448-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212448-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212448-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212448-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212448-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212448-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212448-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212448-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212448-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212448-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212448-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212448-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212448-002	AB3	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212448-001	AB3	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212448-002	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212448-001	AB3	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212448-002	AB3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212448-001	AB3	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212448-002	AB3	1	`ea1830bbd6c7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

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	SPL version
42571-333-01	Metformin Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	4
42571-333-05	Metformin Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	4
42571-333-60	Metformin Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	4
42571-333-90	Metformin Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-333-01	EA - Each	42571-333	21e788d7-aac8-42ae-9f18-119b8120eaec	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-333	METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MICRO LABS LIMITED]	2	Current NDC, 4 package rows	20250515_cc070735-5e8d-4bb3-9caa-e84d29bb8943.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
1807888	metFORMIN HCl 1000 MG Modified 24HR Extended Release Oral Tablet	PSN	cc070735-5e8d-4bb3-9caa-e84d29bb8943	4
1807915	metFORMIN HCl 500 MG Modified 24HR Extended Release Oral Tablet	PSN	cc070735-5e8d-4bb3-9caa-e84d29bb8943	4
1807888	Modified 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	cc070735-5e8d-4bb3-9caa-e84d29bb8943	4
1807915	Modified 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	cc070735-5e8d-4bb3-9caa-e84d29bb8943	4
1807888	metformin HCl 1000 MG Modified 24 HR Extended Release Oral Tablet	SY	cc070735-5e8d-4bb3-9caa-e84d29bb8943	4
1807915	metformin HCl 500 MG Modified 24 HR Extended Release Oral Tablet	SY	cc070735-5e8d-4bb3-9caa-e84d29bb8943	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42571-333-01	42571033301	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-01)	2023-03-01	No	No	Current
42571-333-05	42571033305	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-05)	2023-03-01	No	No	Current
42571-333-60	42571033360	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-60)	2023-03-01	No	No	Current
42571-333-90	42571033390	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-90)	2023-03-01	No	No	Current