Metformin HCl

Product NDC: 72789-192
Requested package NDC: 72789-192-21
11-digit product format: 727890192
Labeler code: 72789
Product ID: 72789-192_373a1d26-a38f-a2c2-e063-6394a90a7403
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin HCl
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA090564
Marketing category: ANDA
Marketing start: 2017-02-06
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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
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
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): 72789-192-21 ndc (product): 72789-192 ndc11 (package): 72789019221
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE TABLET	Granules India Ltd	8cd5555c-f6b2-28d8-e053-2a95a90a5f1e	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Unit Dose Solutions, Inc.	5538e9df-0983-9281-e063-6394a90a9249	2026-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	552ad61d-bafd-478d-e063-6294a90a02f9	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Unit Dose Solutions, Inc.	552df462-6dcb-e6f2-e063-6294a90aacfe	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Major Pharmaceuticals	5e783025-bf6d-465e-bf58-bcd253afad2c	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c3	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	902d1bc4-3f1f-4a1a-86d7-cf98c56a3684	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	33550b88-d4bb-4ce6-a7db-07c966f6984f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	53e950f5-c58f-78e3-e063-6294a90a53e9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Proficient Rx LP	d2c927eb-12bf-4c7d-9ef5-0036b2dd8c29	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Northwind Health Company, LLC	13b1e35f-d047-8ddc-e063-6394a90a24dd	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	51285096-e2ce-0f3c-e063-6394a90a35d4	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Granules Pharmaceuticals Inc.	2387a618-24d8-4813-aa83-9114edb35374	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	59a4ccda-5487-4ac4-9373-0c0fc8b7c88b	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	b51da8d7-ab4a-4c40-97c9-88bd379366d1	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564

Additional Listing Data#

Finished product: Yes
Brand name base: Metformin HCl
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 · 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
fb890205-5d43-41eb-97b2-fb0dcdd3a950	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
72789-192-20	Metformin HCl	20 in 1 BOTTLE, PLASTIC	TABLET	20	13
72789-192-21	Metformin HCl	21 in 1 BOTTLE, PLASTIC	TABLET	21	13
72789-192-30	Metformin HCl	30 in 1 BOTTLE, PLASTIC	TABLET	30	13
72789-192-60	Metformin HCl	60 in 1 BOTTLE, PLASTIC	TABLET	60	13
72789-192-90	Metformin HCl	90 in 1 BOTTLE, PLASTIC	TABLET	90	13
72789-192-93	Metformin HCl	180 in 1 BOTTLE, PLASTIC	TABLET	180	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-192-20	EA - Each	72789-192	59e58c52-e3de-48aa-8064-6d2067b07b37	1	2022-01-06
72789-192-21	EA - Each	72789-192	5979a821-f16f-4722-a738-30d6be27b893	1	2022-10-06
72789-192-30	EA - Each	72789-192	cc3751ee-fc90-4378-b904-a1f9f4612e8b	1	2021-11-09
72789-192-60	EA - Each	72789-192	4da5badf-244b-4238-a506-355d95d64ed6	1	2021-11-09
72789-192-90	EA - Each	72789-192	974ace86-964e-4d38-90ff-c097dafa984c	1	2021-07-15
72789-192-93	EA - Each	72789-192	11402288-1ded-4dee-a6a9-043193748af5	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-192	METFORMIN HCL TABLET [PD-RX PHARMACEUTICALS, INC.]	12	Current NDC, Legacy NDC, 6 package rows	20241011_fb890205-5d43-41eb-97b2-fb0dcdd3a950.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
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	fb890205-5d43-41eb-97b2-fb0dcdd3a950	13
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	fb890205-5d43-41eb-97b2-fb0dcdd3a950	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-192-21	72789019221	21 TABLET in 1 BOTTLE, PLASTIC (72789-192-21)	21 tablet	2022-08-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride Tablets USP	PD-Rx Pharmaceuticals, Inc.	2026-07-13	HUMAN PRESCRIPTION DRUG LABEL	14