Metformin Hydrochloride

Product NDC: 72789-451
Requested package NDC: 72789-451-30
11-digit product format: 727890451
Labeler code: 72789
Product ID: 72789-451_47ba4996-d987-5e87-e063-6394a90a0554
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA078321
Marketing category: ANDA
Marketing start: 2024-02-15
Substance: METFORMIN HYDROCHLORIDE
Active strength: 750 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
A078321-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-04-17
A078321-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078321-001	AB1
A078321-002	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	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-04-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-04-17	`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	A078321-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078321-002	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 2 · 21 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 application applno (ANDA): 078321 application number: ANDA078321 ndc (package): 72789-451-30 ndc (product): 72789-451 ndc11 (package): 72789045130
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68d0b1a6-c99e-42cf-afdf-b71ee73c4424	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1503bbe4-0ac5-479b-9900-d38e49236bf0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	4d245bc3-0add-4651-b441-86b93c5ac681	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	60142fb2-16da-4f54-a542-74f9a70b9c8b	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1d0b74de-ef4c-4dd2-8019-2ddb409c60b4	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	AvPAK	d9bac244-1725-5bf3-e053-2a95a90ac823	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	AvPAK	de09f7a1-1e9f-60f4-e053-2a95a90a93d8	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	ab80521b-5014-cc2a-e053-2a95a90a2003	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	c568d49f-c040-4f1e-ad36-77b05ab659c3	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	bf918d78-3fb6-4d8d-b42d-538ea10bc3e4	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e55ee270-5eb9-4848-8529-9af2a79669c0	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	TAGI Pharma, Inc.	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	2025-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	de4a660b-172b-4c72-9e38-5634fd03cfa7	2025-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	7cb47c3e-6657-4c11-8aa2-ae172e5a8529	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	RedPharm Drug, Inc.	fc61bafa-a506-14ae-e053-6394a90a9c7d	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	direct rx	a84cf1a3-3820-cd1b-e053-2995a90acf45	2025-01-22	Warnings	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride Extended-Release 500mg	METFORMIN HYDROCHLORIDE	Calvin Scott & Co., Inc.	e9cd0d23-56eb-40dd-abf4-9e681ec220f5	2023-02-07	Warnings	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	d80aa4af-a8ce-4cae-b71c-05e1de829551	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4d89a4ab-6cdd-4c39-92f9-a137fa27a070	2021-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321

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	750 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
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
41408f64-d366-403e-9595-464ab25c6f97	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	Strength	SPL version
72789-451-30	Metformin Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30		4
72789-451-60	Metformin Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-451-30	EA - Each	72789-451	31fb8442-a383-434d-b328-dd0aa785a899	1	2025-05-14
72789-451-60	EA - Each	72789-451	e9b38e38-ab59-4b7f-9652-48ea869a00cf	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-451	METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	3	Current NDC, 2 package rows	20250122_41408f64-d366-403e-9595-464ab25c6f97.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
860981	metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet	PSN	41408f64-d366-403e-9595-464ab25c6f97	4
860981	24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet	SCD	41408f64-d366-403e-9595-464ab25c6f97	4
860981	metformin HCl 750 MG 24 HR Extended Release Oral Tablet	SY	41408f64-d366-403e-9595-464ab25c6f97	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72789-451-30	72789045130	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-451-30)	2025-01-20	No	No	Current