Metformin Hydrochloride

Product NDC: 68645-300
Requested package NDC: 68645-300-59
11-digit product format: 686450300
Labeler code: 68645
Product ID: 68645-300_e660bc2f-d56b-e101-e053-2a95a90a8c18
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Legacy Pharmaceutical Packaging, LLC
Application: ANDA077095
Marketing category: ANDA
Marketing start: 2012-01-13
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 1000 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68645-300	68645-300-59	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	Approval date
A077095-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14
A077095-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14
A077095-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077095-001	AB
A077095-002	AB
A077095-003	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	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`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	A077095-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077095-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077095-003	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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	4ac6d01a-af26-44e7-ae2e-3618de0080aa	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	fc466c46-abaa-4675-aef2-4b1a1adfd912	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5d8d654a-9bb4-4c87-ab43-c21c4e874708	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	fb296500-55cb-45ce-be0c-59aa2e3d4624	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	073cf6d9-7142-4d8b-898e-174c62a1f76f	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0448c618-2f0d-4ed3-866f-74b413cf902d	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1d7556eb-82b4-4085-b0b1-dc061b216feb	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	db113f46-6fac-9005-e053-2995a90a017a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3d450933-8d9d-27de-e063-6294a90ae6d9	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3ab4efb6-bd30-2583-e063-6294a90a415b	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	23aa50c5-28fe-4322-b5c6-1f1c48409b16	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	390c3bdf-bfaf-203e-e063-6394a90a7d20	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f6	2024-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	afb183f6-a13c-4f00-82d5-9fe336173d34	2024-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	1b9b6db9-1bac-4252-a03c-18dc0271f05f	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68645-300-59	EA - Each	68645-300	1ad8e97b-4a89-4725-9b10-8f919a01151f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	4
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	4
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	4
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	4
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68645-300	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC]	12	Legacy NDC	20241016_3814cfed-029f-4231-bba3-89b2b4e01392.zip

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	Marketing start	Marketing end	Sample	Exclude flag	Status
68645-300-59	68645030059	60 TABLET, FILM COATED in 1 BOTTLE (68645-300-59)	2012-01-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride Tablets, USP	Legacy Pharmaceutical Packaging, LLC	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	13