Metformin hydrochloride

Product NDC: 24724-014
Requested package NDC: 24724-014-01
11-digit product format: 247240014
Labeler code: 24724
Product ID: 24724-014_7ba4b972-10a4-43d3-9b5f-ec4915db9d88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: INDICUS PHARMA LLC
Application: ANDA079148
Marketing category: ANDA
Marketing start: 2009-06-03
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	24724-014	24724-014-01	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A079148-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25
A079148-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25
A079148-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079148-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2008-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079148-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2008-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079148-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2008-11-25	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A079148-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079148-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079148-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079148-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079148-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079148-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079148-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079148-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079148-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079148-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079148-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079148-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079148-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079148-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079148-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079148-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079148-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079148-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079148-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079148-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079148-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079148-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079148-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079148-003	AB	1	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24724-014-01	2025-01-30	C162847	48780-1	2cef2736-6504-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
24724-014-50	2025-01-30	C162847	48780-1	2cef2736-6504-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24724-014-01	Metformin hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		5
24724-014-50	Metformin hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Metformin Hydrochloride	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1
Metformin	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1
Colloidal Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1
Corn Starch	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1
Hypromellose	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1
Polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1
Povidone	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1
Sodium Starch Glycolate	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	METFORMIN HYDROCHLORIDE TABLET [USV LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24724-014	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [INDICUS PHARMA LLC]	5	Legacy NDC, 2 package rows	20201204_56d13a1c-b289-4528-b23c-60f5427b4552.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
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	56d13a1c-b289-4528-b23c-60f5427b4552	5
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	56d13a1c-b289-4528-b23c-60f5427b4552	5
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	56d13a1c-b289-4528-b23c-60f5427b4552	5
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	56d13a1c-b289-4528-b23c-60f5427b4552	5
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	56d13a1c-b289-4528-b23c-60f5427b4552	5
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	56d13a1c-b289-4528-b23c-60f5427b4552	5
861004	metformin HCl 1 GM Oral Tablet	SY	56d13a1c-b289-4528-b23c-60f5427b4552	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24724-014-01	24724001401	100 TABLET, FILM COATED in 1 BOTTLE (24724-014-01)	2009-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin hydrochloride	INDICUS PHARMA LLC \| USV Private Limited	2020-12-03	Human Prescription Drug Label	5