Metformin Hydrochloride

Product NDC: 57664-435
11-digit product format: 576640435
Labeler code: 57664
Product ID: 57664-435_7274fdaf-11f8-2b2f-e053-2991aa0ad3f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA075967
Marketing category: ANDA
Marketing start: 2002-01-29
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 850 mg/1
Pharmacologic classes: Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57664-435		D	Discontinued by firm	2026-10-05
excluded package	package	57664-435	57664-435-51	D	Discontinued by firm	2026-10-05
excluded package	package	57664-435	57664-435-53	D	Discontinued by firm	2026-10-05
excluded package	package	57664-435	57664-435-58	D	Discontinued by firm	2026-10-05
excluded package	package	57664-435	57664-435-59	D	Discontinued by firm	2026-10-05

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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-435-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-435-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-435-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-435-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-435-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-435-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-435-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-435-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-435-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-435-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-435-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-435-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-435-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-435-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-435-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-435-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-435-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-435-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-435-59	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-435-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-435-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-435-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-435-59	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-435-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-435-58	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-435-51	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-435-59	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-435-53	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-435-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-435-51	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-435-59	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-435-53	`ed331223b511…`	`672a5bd82f5f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075967-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29
A075967-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29
A075967-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075967-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075967-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075967-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075967-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075967-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075967-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075967-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075967-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075967-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075967-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075967-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075967-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075967-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075967-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075967-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075967-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075967-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075967-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075967-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075967-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075967-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075967-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075967-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075967-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075967-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075967-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075967-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075967-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075967-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075967-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075967-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075967-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075967-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075967-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075967-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075967-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075967-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075967-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075967-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075967-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075967-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075967-003	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075967-001	AB	1	`a67488948f0b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
57664-435-51	EA - Each	57664-435	7433e9aa-87ae-446e-bf3e-0c6386278180	1	2012-07-24
57664-435-53	EA - Each	57664-435	04ca6a48-c9e6-4a18-9f4c-3722cbe90851	1	2012-07-24
57664-435-58	EA - Each	57664-435	08ef45b0-cb1f-4f4c-a9df-c3de0406d28a	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 METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	5
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	5
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METFORMIN HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METFORMIN HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METFORMIN HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	METFORMIN HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1

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	416a6446-81cc-43af-8d9c-788c91a2a1d3	5
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	416a6446-81cc-43af-8d9c-788c91a2a1d3	5
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	416a6446-81cc-43af-8d9c-788c91a2a1d3	5
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	416a6446-81cc-43af-8d9c-788c91a2a1d3	5
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	416a6446-81cc-43af-8d9c-788c91a2a1d3	5
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	416a6446-81cc-43af-8d9c-788c91a2a1d3	5
861004	metformin HCl 1 GM Oral Tablet	SY	416a6446-81cc-43af-8d9c-788c91a2a1d3	5
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	c80870d1-b42f-4478-9844-7eebf99d43a3	4
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	c80870d1-b42f-4478-9844-7eebf99d43a3	4
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	c80870d1-b42f-4478-9844-7eebf99d43a3	4
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	c80870d1-b42f-4478-9844-7eebf99d43a3	4
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	c80870d1-b42f-4478-9844-7eebf99d43a3	4
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	c80870d1-b42f-4478-9844-7eebf99d43a3	4
861004	metformin HCl 1 GM Oral Tablet	SY	c80870d1-b42f-4478-9844-7eebf99d43a3	4
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	f0a43cae-0f19-4a60-8a82-895cc4ea0001	2
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	f0a43cae-0f19-4a60-8a82-895cc4ea0001	2
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	f0a43cae-0f19-4a60-8a82-895cc4ea0001	2
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	f0a43cae-0f19-4a60-8a82-895cc4ea0001	2
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	f0a43cae-0f19-4a60-8a82-895cc4ea0001	2
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	f0a43cae-0f19-4a60-8a82-895cc4ea0001	2
861004	metformin HCl 1 GM Oral Tablet	SY	f0a43cae-0f19-4a60-8a82-895cc4ea0001	2
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	495738b9-2511-446b-833c-164c0119035b	1
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	495738b9-2511-446b-833c-164c0119035b	1
861010	metFORMIN HCl 850 MG Oral Tablet	PSN	495738b9-2511-446b-833c-164c0119035b	1
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	495738b9-2511-446b-833c-164c0119035b	1
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	495738b9-2511-446b-833c-164c0119035b	1
861010	metformin hydrochloride 850 MG Oral Tablet	SCD	495738b9-2511-446b-833c-164c0119035b	1
861004	metformin HCl 1 GM Oral Tablet	SY	495738b9-2511-446b-833c-164c0119035b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-435-51	57664043551	100 TABLET in 1 BOTTLE (57664-435-51)	100 tablet	2002-01-29	0000-00-00	No	No	Current
57664-435-53	57664043553	500 TABLET in 1 BOTTLE (57664-435-53)	500 tablet	2002-01-29	0000-00-00	No	No	Current
57664-435-58	57664043558	1000 TABLET in 1 BOTTLE (57664-435-58)	1000 tablet	2002-01-29	0000-00-00	No	No	Current
57664-435-59	57664043559	90 TABLET in 1 BOTTLE (57664-435-59)	90 tablet	2002-01-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride Tablets, USP	REMEDYREPACK INC.	2019-07-23	HUMAN PRESCRIPTION DRUG LABEL	3
Metformin Hydrochloride Tablets, USP	REMEDYREPACK INC.	2019-01-22	HUMAN PRESCRIPTION DRUG LABEL	4
Metformin Hydrochloride Tablets, USP	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Ind. Ltd	2018-08-02	HUMAN PRESCRIPTION DRUG LABEL	6
Metformin Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-09-13	Human Prescription Drug Label	4
METFORMIN HYDROCHLORIDE	Rebel Distributors Corp.	2010-10-04	HUMAN PRESCRIPTION DRUG LABEL	1
METFORMIN HYDROCHLORIDE - Med-Health Pharma, LLC	Med-Health Pharma, LLC	2010-03-30	Human Prescription Drug Label	5
METFORMIN HYDROCHLORIDE	State of Florida DOH Central Pharmacy	2010-03-04	HUMAN PRESCRIPTION DRUG LABEL	2