Metformin ER 500 mg

Product NDC: 62207-491
Requested package NDC: 62207-491-43
11-digit product format: 622070491
Labeler code: 62207
Product ID: 62207-491_4ce18ed1-a825-c596-e063-6394a90a7192
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin ER 500 mg
Dosage form: TABLET
Route: ORAL
Labeler: Granules India Ltd
Application: ANDA209313
Marketing category: ANDA
Marketing start: 2018-06-28
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209313-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-03-16
A209313-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209313-001	AB1
A209313-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A209313-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209313-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`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	A209313-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209313-002	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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin ER 500 mg	METFORMIN ER 500 MG	Granules India Ltd	b857eccf-b9ff-45ba-8241-f47f5caada2a	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313 ndc (package): 62207-491-43 ndc (product): 62207-491 ndc11 (package): 62207049143
Metformin	METFORMIN ER 500 MG	Coupler LLC	54620ea3-da64-c5d7-e063-6394a90ad14a	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Granules Pharmaceuticals Inc.	6d6ee6f8-9650-ff4f-e053-2991aa0acf19	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Bryant Ranch Prepack	c047cf64-467a-40f3-be46-a1926b3b8d56	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Legacy Pharmaceutical Packaging, LLC	d9e0816d-fd61-1ac2-e053-2995a90a4054	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin ER 500 mg	METFORMIN ER 500 MG	Quallent Pharmaceuticals Health LLC	ff196435-14f4-8b9d-e053-6294a90a4ee8	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	REMEDYREPACK INC.	05999192-ebc6-4198-bd1e-f46abbfb4f8a	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	A-S Medication Solutions	fdd3481c-aaec-47ac-9790-01de68b2e253	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 750 MG	Bryant Ranch Prepack	f1058475-1318-49a0-89ce-da06692b0e5b	2024-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Proficient Rx LP	92855c8d-59be-458b-97f1-2ff11b9bf6b0	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 750 MG	A-S Medication Solutions	9e3791fb-9a34-4982-8164-0502fa398b01	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 750 MG	A-S Medication Solutions	953404a4-0f03-42f1-8136-43238dad11f4	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Bryant Ranch Prepack	1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	A-S Medication Solutions	c6fddb05-6b9b-4088-8ce7-17fb94c13cc2	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313
Metformin	METFORMIN ER 500 MG	Aphena Pharma Solutions - Tennessee, LLC	5c10eaa2-d6ba-446a-8f16-f5a8ca7223d7	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209313 application number: ANDA209313

Additional Listing Data#

Finished product: Yes
Brand name base: Metformin ER 500 mg
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860975	Internal RxNorm lookup
860981	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
b857eccf-b9ff-45ba-8241-f47f5caada2a	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
62207-491-31	Metformin ER 500 mg	5000 in 1 POUCH	TABLET	5000	15
62207-491-35	Metformin ER 500 mg	25000 in 1 CARTON	TABLET	25000	15
62207-491-43	Metformin ER 500 mg	100 in 1 BOTTLE	TABLET	100	15
62207-491-47	Metformin ER 500 mg	500 in 1 BOTTLE	TABLET	500	15
62207-491-49	Metformin ER 500 mg	1000 in 1 BOTTLE	TABLET	1000	15
62207-491-54	Metformin ER 500 mg	30 in 1 BOTTLE	TABLET	30	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62207-491	METFORMIN ER 500 MG TABLET METFORMIN ER 750 MG TABLET [GRANULES INDIA LTD]	13	Current NDC, Legacy NDC, 6 package rows	20230129_b857eccf-b9ff-45ba-8241-f47f5caada2a.zip

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	b857eccf-b9ff-45ba-8241-f47f5caada2a	15
860981	metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet	PSN	b857eccf-b9ff-45ba-8241-f47f5caada2a	15
860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	b857eccf-b9ff-45ba-8241-f47f5caada2a	15
860981	24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet	SCD	b857eccf-b9ff-45ba-8241-f47f5caada2a	15
860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY	b857eccf-b9ff-45ba-8241-f47f5caada2a	15
860981	metformin HCl 750 MG 24 HR Extended Release Oral Tablet	SY	b857eccf-b9ff-45ba-8241-f47f5caada2a	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62207-491-43	62207049143	100 TABLET in 1 BOTTLE (62207-491-43)	100 tablet	2019-07-25	0000-00-00	No	No	Current