METFORMIN HYDROCHLORIDE

Product NDC: 65841-810
11-digit product format: 658410810
Labeler code: 65841
Product ID: 65841-810_f845896f-d006-4f67-9de6-a734ca665025
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METFORMIN HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA203686
Marketing category: ANDA
Marketing start: 2014-12-09
Substance: METFORMIN HYDROCHLORIDE
Active strength: 850 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203686-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28
A203686-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28
A203686-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203686-001	AB
A203686-002	AB
A203686-003	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.

Product history page 1 of 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203686-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203686-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203686-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203686-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203686-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203686-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203686-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203686-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203686-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203686-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: METFORMIN HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	850 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860975	Internal RxNorm lookup
861004	Internal RxNorm lookup
861010	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
5043d03e-3c9d-4c96-b48d-187f02a1d27c	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-810-01	METFORMIN HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	14
65841-810-05	METFORMIN HYDROCHLORIDE	500 in 1 BOTTLE	TABLET, FILM COATED	500	14
65841-810-10	METFORMIN HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	14
65841-810-16	METFORMIN HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	14
65841-810-30	METFORMIN HYDROCHLORIDE	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	14
65841-810-77	METFORMIN HYDROCHLORIDE	100 in 1 CARTON	TABLET, FILM COATED	100	14

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 [CADILA HEALTHCARE LIMITED]	4
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	4
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-810	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	14	Current NDC, Legacy NDC, 6 package rows	20241207_5043d03e-3c9d-4c96-b48d-187f02a1d27c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	25be863d-490c-47f6-9ad3-c828dc43fbf0	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203686 application number: ANDA203686
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c82a10fa-1e8e-46b6-890a-737de3f34ee1	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203686 application number: ANDA203686
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	5043d03e-3c9d-4c96-b48d-187f02a1d27c	2024-12-05		Exact identifier application applno (ANDA): 203686 application number: ANDA203686 ndc (product): 65841-810
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	American Health Packaging	dd54d30b-9390-4e5a-bf62-fbf18b91e4cd	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203686 application number: ANDA203686

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
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	5043d03e-3c9d-4c96-b48d-187f02a1d27c	14
860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	5043d03e-3c9d-4c96-b48d-187f02a1d27c	14
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	5043d03e-3c9d-4c96-b48d-187f02a1d27c	14
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	5043d03e-3c9d-4c96-b48d-187f02a1d27c	14
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	5043d03e-3c9d-4c96-b48d-187f02a1d27c	14
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	5043d03e-3c9d-4c96-b48d-187f02a1d27c	14
861004	metformin HCl 1 GM Oral Tablet	SY	5043d03e-3c9d-4c96-b48d-187f02a1d27c	14
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	5043d03e-3c9d-4c96-b48d-187f02a1d27c	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-810-01	65841081001	100 TABLET, FILM COATED in 1 BOTTLE (65841-810-01)		2014-12-09	0000-00-00	No	No	Current
65841-810-05	65841081005	500 TABLET, FILM COATED in 1 BOTTLE (65841-810-05)		2014-12-09	0000-00-00	No	No	Current
65841-810-10	65841081010	1000 TABLET, FILM COATED in 1 BOTTLE (65841-810-10)		2014-12-09	0000-00-00	No	No	Current
65841-810-16	65841081016	90 TABLET, FILM COATED in 1 BOTTLE (65841-810-16)		2014-12-09	0000-00-00	No	No	Current
65841-810-30	65841081030	1 in 1 BLISTER PACK						Historical
65841-810-77	65841081077	100 BLISTER PACK in 1 CARTON (65841-810-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65841-810-30)	100 blister pack	2014-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE TABLETS	Zydus Lifesciences Limited	2024-12-05	HUMAN PRESCRIPTION DRUG LABEL	14