METFORMIN HYDROCHLORIDE

Product NDC: 68071-3526
11-digit product format: 680713526
Labeler code: 68071
Product ID: 68071-3526_2d3f923b-0c50-0cec-e063-6294a90ae8fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metformin hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA213320
Marketing category: ANDA
Marketing start: 2023-01-19
Substance: METFORMIN HYDROCHLORIDE
Active strength: 1000 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3526-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3526-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3526-1	`0efc9e666f02…`	`f202fb6c5f17…`

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
A213320-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03
A213320-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03
A213320-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213320-001	AB
A213320-002	AB
A213320-003	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 3 · 99 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	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A213320-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213320-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213320-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213320-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213320-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213320-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213320-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213320-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213320-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213320-001	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	1000 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861004	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
0865f83f-0f34-0690-e063-6294a90abf04	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-3526-1	2025-02-03	C162847	48780-1	2cef2736-63c9-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
68071-3526-1	2025-01-30	C162847	48780-1	2cef2736-63c9-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3526-1	METFORMIN HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3526	METFORMIN HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 1 package rows	20250205_0865f83f-0f34-0690-e063-6294a90abf04.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4d087f00-580b-4b9d-80d9-f97930153e72	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4182bcf0-1f9a-4f3a-9428-86b5d757954f	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	14450912-54b5-4fc3-ba65-77ece864b2e7	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	QPharma Inc	53bde438-4277-f418-e063-6394a90a5ea2	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	1e7ab8da-4ece-499c-b0fb-34e37d991c1c	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	abd0dad9-5f29-4102-a099-dce7bdddb98b	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	239834b0-121a-4903-b3ee-90bb4db4753b	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	5f2023d2-05ae-489d-9e18-fb75057496bc	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5073c482-952c-400c-afff-64380f133bc8	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e3e9b582-fd15-4fe0-a210-398d9149696e	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b63bfafa-db4c-4fb8-84cd-ff73a5e7d320	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	8c7835fa-3f68-4850-b1da-34893bafb485	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3cbb802d-d493-255e-e063-6294a90a32f2	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
Metformin HCL	METFORMIN HCL	Direct_Rx	2ffeb25a-76a9-01e6-e063-6394a90ae332	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
Metformin HCL	METFORMIN HCL	Direct_Rx	3ac4e864-4b8a-13b1-e063-6294a90ada66	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Coupler LLC	2d7d9364-e71d-4ef6-e063-6394a90af841	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0865f83f-0f34-0690-e063-6294a90abf04	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320 ndc (product): 68071-3526
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0b3d5420-d60c-8385-e063-6394a90abb6c	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	289dc8ec-42c8-1d09-e063-6394a90a97f0	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0710e208-5b2c-3c72-e063-6394a90a4dac	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320

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	0865f83f-0f34-0690-e063-6294a90abf04	2
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	0865f83f-0f34-0690-e063-6294a90abf04	2
861004	metformin HCl 1 GM Oral Tablet	SY	0865f83f-0f34-0690-e063-6294a90abf04	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3526-1	68071352601	100 TABLET in 1 BOTTLE (68071-3526-1)	100 tablet	2023-10-23	No	No	Current