Metformin Hydrochloride

Product NDC: 62037-571
Requested package NDC: 62037-571-10
11-digit product format: 620370571
Labeler code: 62037
Product ID: 62037-571_09f7dce6-15ab-4efe-b1bc-5d9e1b6b9049
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA076172
Marketing category: ANDA
Marketing start: 2004-06-01
Marketing end: 2021-11-30
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	62037-571	62037-571-10	D	Discontinued by firm		2026-10-12

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 · 12 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A076172-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL			2004-06-16

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 · 43 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	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076172-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2004-06-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076172-001	AB1	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A076172-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076172-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076172-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076172-001	AB1	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62037-571-01	EA - Each	62037-571	f6661290-cbb3-44f4-9c11-e5fed2cf44d6	1	2013-02-13
62037-571-10	EA - Each	62037-571	595f7042-48ef-4dc6-a2fc-ca6fd13d283e	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON PHARMA, INC.]	11
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2

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
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	009797a6-5b91-42aa-ac9f-f0d2d0675624	2
860981	metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet	PSN	009797a6-5b91-42aa-ac9f-f0d2d0675624	2
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	009797a6-5b91-42aa-ac9f-f0d2d0675624	2
860981	24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet	SCD	009797a6-5b91-42aa-ac9f-f0d2d0675624	2
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	009797a6-5b91-42aa-ac9f-f0d2d0675624	2
860981	metformin HCl 750 MG 24 HR Extended Release Oral Tablet	SY	009797a6-5b91-42aa-ac9f-f0d2d0675624	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62037-571-10	62037057110	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-571-10)	2004-06-01	2021-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP Rx Only	Actavis Pharma, Inc.	2017-06-30	HUMAN PRESCRIPTION DRUG LABEL	17
METFORMIN HYDROCHLORIDE, USP TABLETS and METFORMIN HYDROCHLORIDE, USP EXTENDED-RELEASE TABLETS	Blenheim Pharmacal, Inc.	2015-02-27	HUMAN PRESCRIPTION DRUG LABEL	2