METFORMIN HYDROCHLORIDE

Product NDC: 43353-987
Requested package NDC: 43353-987-96
11-digit product format: 433530987
Labeler code: 43353
Product ID: 43353-987_4900492c-70fa-e5b5-e063-6294a90af743
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METFORMIN HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA203769
Marketing category: ANDA
Marketing start: 2013-09-11
Substance: METFORMIN HYDROCHLORIDE
Active strength: 1000 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 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203769-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11
A203769-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11
A203769-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11
A203769-004	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2026-02-09
A203769-005	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2026-02-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A203769-001	AB
A203769-002	AB
A203769-003	AB
A203769-004	AB
A203769-005	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 · 127 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	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-004	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2026-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-005	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2026-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 127 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	A203769-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203769-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203769-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203769-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203769-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203769-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203769-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203769-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203769-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203769-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203769-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203769-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203769-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203769-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203769-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203769-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203769-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203769-002	AB	1	`1e350fbaab3a…`

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	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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861004	Internal RxNorm lookup
861007	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
273d86b0-9d30-48c9-8918-c5e1ececa951	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
43353-987-30	METFORMIN HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	6
43353-987-31	METFORMIN HYDROCHLORIDE	600 in 1 BOTTLE	TABLET	600	6
43353-987-43	METFORMIN HYDROCHLORIDE	1300 in 1 BOTTLE	TABLET	1300	6
43353-987-45	METFORMIN HYDROCHLORIDE	45 in 1 BOTTLE	TABLET	45	6
43353-987-53	METFORMIN HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60	6
43353-987-60	METFORMIN HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	6
43353-987-73	METFORMIN HYDROCHLORIDE	135 in 1 BOTTLE	TABLET	135	6
43353-987-80	METFORMIN HYDROCHLORIDE	180 in 1 BOTTLE	TABLET	180	6
43353-987-86	METFORMIN HYDROCHLORIDE	225 in 1 BOTTLE	TABLET	225	6
43353-987-87	METFORMIN HYDROCHLORIDE	2400 in 1 BOTTLE	TABLET	2400	6
43353-987-96	METFORMIN HYDROCHLORIDE	450 in 1 BOTTLE	TABLET	450	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-987-30	EA - Each	43353-987	94c193cc-6da4-44c5-bba6-8a64dd2edf6c	1	2016-07-19
43353-987-31	EA - Each	43353-987	184842c5-be48-435c-a956-f47847284b04	1	2024-08-12
43353-987-43	EA - Each	43353-987	f86b0bba-63cd-4954-9edf-93b1148809d3	1	2024-08-12
43353-987-45	EA - Each	43353-987	ef2a647f-6b6b-461b-9693-32fd1539182f	1	2016-07-19
43353-987-53	EA - Each	43353-987	b57de7b5-33c0-4abe-b63c-675fd455ec29	1	2016-07-19
43353-987-60	EA - Each	43353-987	8a9df6ca-8e2d-4903-946c-7abe672b7a9e	1	2016-07-19
43353-987-73	EA - Each	43353-987	a5fa460a-3712-4aeb-a92a-ed939aa8f3a8	1	2016-07-19
43353-987-80	EA - Each	43353-987	9a8ad0d4-e2f5-4006-8f7a-c2bf7db337bd	1	2016-07-19
43353-987-86	EA - Each	43353-987	9f2742ec-ffd8-4f98-bef3-d6c269e7977e	1	2016-07-19
43353-987-87	EA - Each	43353-987	8e9f4fa2-ae31-4d4f-aa8a-029b8e3321f7	1	2024-08-12
43353-987-96	EA - Each	43353-987	15056e42-30bd-4c76-8988-fbdcfc3f77b0	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-987	METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	5	Current NDC, Legacy NDC, 11 package rows	20240618_273d86b0-9d30-48c9-8918-c5e1ececa951.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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	13235d8e-ac3a-45b4-9c5d-9a9012951dfe	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	836f3647-bfef-40d1-b475-c0d240241a67	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	388ee1e0-a0d2-324d-e063-6394a90a1664	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	direct rx	c33e24e9-0441-6b94-e053-2a95a90a9c68	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Method Pharmaceuticals, LLC.	4aa880a4-7ec0-9155-e063-6394a90a8f3e	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc	dfac4d9c-2f20-417c-a1be-4f1c2738f351	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	273d86b0-9d30-48c9-8918-c5e1ececa951	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769 ndc (package): 43353-987-96 ndc (product): 43353-987 ndc11 (package): 43353098796
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	72dbc087-9a84-4126-bf54-c5254a8b129c	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3982b985-9184-0e17-e063-6394a90aae05	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3890b116-7c3c-e48e-e063-6294a90a0c8a	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	ec3a9070-3745-41fb-b610-8d06129d8fd9	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	51e1fe6e-a7fa-47a5-bbd5-73b275230c7f	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	32d6c5f4-0116-4e38-b179-e1967ae63e66	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	4670d280-53c3-4c51-b3c5-26d71e47bddc	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	928ef685-80cb-42a9-a155-3c21c9b1dd67	2024-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	9c33414b-5dbb-4ce9-910b-9480d45e50ee	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	f9e78e0f-6a0a-4db3-bc09-5500748f9c84	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	88af3365-1145-45a1-ab0f-1c794f0c13db	2023-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	8ce6b615-2abd-4a5b-997b-11aa1aec142d	2023-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	f86bda10-8b25-4125-8bb1-1b5917969ff0	2023-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203769 application number: ANDA203769

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	273d86b0-9d30-48c9-8918-c5e1ececa951	6
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	273d86b0-9d30-48c9-8918-c5e1ececa951	6
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	273d86b0-9d30-48c9-8918-c5e1ececa951	6
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	273d86b0-9d30-48c9-8918-c5e1ececa951	6
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	273d86b0-9d30-48c9-8918-c5e1ececa951	6
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	273d86b0-9d30-48c9-8918-c5e1ececa951	6
861004	metformin HCl 1 GM Oral Tablet	SY	273d86b0-9d30-48c9-8918-c5e1ececa951	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-987-96	43353098796	450 TABLET in 1 BOTTLE (43353-987-96)	450 tablet	2020-05-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2026-01-22	HUMAN PRESCRIPTION DRUG LABEL	6