metformin hydrochloride

Product NDC: 43063-898
11-digit product format: 430630898
Labeler code: 43063
Product ID: 43063-898_e6d92ab1-a85e-17d7-e053-2a95a90ab5b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metformin hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA090564
Marketing category: ANDA
Marketing start: 2010-04-22
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43063-898		D	Discontinued by firm		2026-07-31
excluded package	package	43063-898	43063-898-30	D	Discontinued by firm		2026-07-31

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	RLD / RS	Approval date
A090564-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22
A090564-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22
A090564-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090564-001	AB
A090564-002	AB
A090564-003	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.

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	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`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	A090564-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090564-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090564-003	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 128 · 2,555 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.	41408f64-d366-403e-9595-464ab25c6f97	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68d0b1a6-c99e-42cf-afdf-b71ee73c4424	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9171d369-d35a-40e4-a9ad-26484e66fc5e	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	30658e19-8e6e-49aa-a007-e414224797c5	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (package): 70518-2833-5 ndc (package): 70518-2833-9 ndc (package): 70518-2833-6 ndc (package): 70518-2833-1 ndc (package): 70518-2833-3 ndc (package): 70518-2833-7 ndc (package): 70518-2833-2 ndc (package): 70518-2833-8 ndc (package): 70518-2833-4 ndc (package): 70518-2833-0 ndc (product): 70518-2833 rxcui: 861007 spl id: 57c46cc3-ef60-bbf1-e063-6294a90a73ac spl set id: 30658e19-8e6e-49aa-a007-e414224797c5 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1503bbe4-0ac5-479b-9900-d38e49236bf0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	e22a8545-86a6-439e-a758-29c4d6ed8bfe	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Cardinal Health 107, LLC	46cb7e3f-c739-433d-9dbe-427c2d95bef1	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (package): 55154-4172-0 ndc (product): 55154-4172 rxcui: 861007 spl id: c3c024ed-5f95-4247-ab2f-38439c355d00 spl set id: 46cb7e3f-c739-433d-9dbe-427c2d95bef1 unii: 786Z46389E
True Coast SPF 50 Mineral Sunscreen	ZINC OXIDE 18%, TITANIUM DIOXIDE 6%	Foshan Sugar Max Cosmetics CO.,Ltd	5379466d-8d14-5fc2-e063-6394a90abd7e	2026-07-22	Warnings	Exact identifier unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	571f23e9-1126-e32d-e063-6294a90a9951	2026-07-21	Warnings	Exact identifier unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREEN	MENS SPF50 ALL IN ONE SUNSCREEN	Lance (Guangzhou) Biological Technology Co., Ltd.	57074480-77fd-cc06-e063-6294a90a28d4	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Chartwell RX, LLC	4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 rxcui: 861010 rxcui: 861004 unii: 786Z46389E
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	5711364c-f9b4-bfa6-e063-6294a90ace4a	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
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 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	13235d8e-ac3a-45b4-9c5d-9a9012951dfe	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5aa1c86c-f2c8-49b1-8f81-47b11386c5d3	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (package): 70518-4698-0 ndc (product): 70518-4698 rxcui: 861007 spl id: 56a5a4eb-f1b9-35f3-e063-6394a90a882a spl set id: 5aa1c86c-f2c8-49b1-8f81-47b11386c5d3 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	4ac6d01a-af26-44e7-ae2e-3618de0080aa	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 rxcui: 861010 rxcui: 861004 unii: 786Z46389E
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	b5ccf5da-cbe1-4009-ba1c-990050838ee9	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a086cc29-cb5d-40d0-a57d-8e91f1aa9158	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin HCl	METFORMIN HCL	PD-Rx Pharmaceuticals, Inc.	fb890205-5d43-41eb-97b2-fb0dcdd3a950	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (package): 72789-192-30 ndc (package): 72789-192-21 ndc (package): 72789-192-93 ndc (package): 72789-192-60 ndc (package): 72789-192-20 ndc (product): 72789-192 rxcui: 861007 spl id: 5683dd49-29a1-2b76-e063-6294a90a3c5b spl set id: fb890205-5d43-41eb-97b2-fb0dcdd3a950 unii: 786Z46389E
JANUMET	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c603b844-2019-4ef4-8385-7bc3f96a2565	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-898-20	EA - Each	43063-898	2e32e2d7-d2ba-4eaf-8402-0deeea2cd9d1	1	2019-11-12
43063-898-30	EA - Each	43063-898	34e3bac7-fb2e-4300-9027-714a9256d005	1	2018-12-13
43063-898-60	EA - Each	43063-898	257ea205-cd83-4a38-aafd-024fef0d860f	1	2019-01-24
43063-898-90	EA - Each	43063-898	4b9b43fb-bbb2-459b-8221-621952123276	1	2018-11-06
43063-898-93	EA - Each	43063-898	3b073003-2b65-49c7-b8fe-7676723c85a8	1	2018-12-13
43063-898-98	EA - Each	43063-898	9ef1b7c4-1d8d-4df1-8894-8cba42fe5263	1	2019-03-12

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-898-20	43063089820	20 TABLET in 1 BOTTLE, PLASTIC (43063-898-20)	20 tablet	2019-10-10	0000-00-00	No	No	Current
43063-898-30	43063089830	30 TABLET in 1 BOTTLE, PLASTIC (43063-898-30)	30 tablet	2018-10-26	0000-00-00	No	No	Current
43063-898-60	43063089860	60 TABLET in 1 BOTTLE, PLASTIC (43063-898-60)	60 tablet	2018-11-06	0000-00-00	No	No	Current
43063-898-90	43063089890	90 TABLET in 1 BOTTLE, PLASTIC (43063-898-90)	90 tablet	2019-09-21	0000-00-00	No	No	Current
43063-898-93	43063089893	180 TABLET in 1 BOTTLE, PLASTIC (43063-898-93)	180 tablet	2018-10-16	0000-00-00	No	No	Current
43063-898-98	43063089898	120 TABLET in 1 BOTTLE, PLASTIC (43063-898-98)	120 tablet	2019-01-30	0000-00-00	No	No	Current