Metformin Hydrochloride

Product NDC: 70518-1951
Requested package NDC: 70518-1951-3
11-digit product format: 705181951
Labeler code: 70518
Product ID: 70518-1951_498a95ea-832f-a15d-e063-6394a90a7026
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METFORMIN HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA203769
Marketing category: ANDA
Marketing start: 2019-03-12
Marketing end: 2027-01-01
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 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A203769-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2013-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203769-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2013-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203769-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2013-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203769-004	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2026-02-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203769-005	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2026-02-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A203769-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203769-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203769-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203769-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203769-005	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 70518-1951-3 ndc (product): 70518-1951 ndc11 (package): 70518195103
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
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

Additional Listing Data#

Finished product: Yes
Brand name base: Metformin Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 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
861007	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
13235d8e-ac3a-45b4-9c5d-9a9012951dfe	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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
70518-1951-0	2023-03-07	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-0	2023-03-07	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-0	2023-03-07	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-0	2023-03-07	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-1	2023-03-07	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-1	2023-03-07	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-1	2023-03-07	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-1	2023-03-07	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-0	2023-01-30	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-0	2023-01-30	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-0	2023-01-30	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-0	2023-01-30	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-1	2023-01-30	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-1	2023-01-30	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-1	2023-01-30	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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
70518-1951-1	2023-01-30	C162847	48780-1	f386c64a-1044-0266-e053-dadaa90a7c1a	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	SPL version
70518-1951-0	Metformin Hydrochloride	28 in 1 BLISTER PACK	TABLET, FILM COATED	28	11
70518-1951-1	Metformin Hydrochloride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	11
70518-1951-2	Metformin Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	11
70518-1951-3	Metformin Hydrochloride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	11

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
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	13235d8e-ac3a-45b4-9c5d-9a9012951dfe	11
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	13235d8e-ac3a-45b4-9c5d-9a9012951dfe	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1951-3	70518195103	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1951-3)	2025-10-28	2027-01-01	No	No	Historical