Metformin Hydrochloride

Product NDC
66267-493
11-digit product format
662670493
Labeler code
66267
Product ID
66267-493_9cadef6c-4cec-f2d7-e053-2995a90aa5b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA075967
Marketing category
ANDA
Marketing start
2002-01-29
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66267-493DDiscontinued by firm2026-10-05
excluded packagepackage66267-49366267-493-30DDiscontinued by firm2026-10-05
excluded packagepackage66267-49366267-493-60DDiscontinued by firm2026-10-05
excluded packagepackage66267-49366267-493-90DDiscontinued by firm2026-10-05
excluded packagepackage66267-49366267-493-91DDiscontinued by firm2026-10-05
excluded packagepackage66267-49366267-493-92DDiscontinued by firm2026-10-05

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 2 · 72 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-493-91d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-493-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-493-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-493-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-493-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-493-91f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-493-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-493-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-493-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-493-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-493-912ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-493-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-493-922ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-493-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-493-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-493-91a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-493-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-493-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-493-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-493-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-493-91cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-493-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-493-92cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-493-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-493-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-493-91cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-493-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-493-92cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-493-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-493-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-493-91302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-493-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-493-92302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-493-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-493-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-493-91ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-493-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-493-92ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-493-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-493-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-493-910efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-493-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-493-920efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-493-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-493-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-493-91ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-493-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-493-92ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-493-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-493-30ad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075967-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-29
A075967-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-29
A075967-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-2984e616aacf4f…
2026-09-14 22:38:342026-08A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-2984e616aacf4f…
2026-09-14 22:38:342026-08A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-2984e616aacf4f…
2026-08-18 06:07:402026-07A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075967-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2002-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075967-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2002-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075967-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2002-01-29301d65b070ca…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075967-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075967-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075967-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075967-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075967-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075967-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075967-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075967-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075967-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075967-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075967-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075967-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075967-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075967-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075967-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075967-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075967-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075967-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075967-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075967-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075967-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075967-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075967-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075967-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075967-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075967-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075967-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075967-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075967-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075967-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075967-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075967-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075967-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075967-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075967-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075967-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075967-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075967-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075967-003AB1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075967-001AB1a67488948f0b…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-493-30EA - Each66267-493717c0e3b-6bea-4955-9105-70656146fec812017-03-06
66267-493-60EA - Each66267-49333e678a7-58a8-4281-9b50-363655cbbc2f12017-03-06
66267-493-90EA - Each66267-4938f641d7b-0386-4a4d-9a15-63c1720f8fc912017-03-06
66267-493-91EA - Each66267-493d5ed931e-5cf4-47bc-ac84-4d81e632064e12017-03-06
66267-493-92EA - Each66267-493a7a58bb1-24ab-45d6-801b-1d982afdf7df12017-03-06