FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
65162-177
11-digit product format
651620177
Labeler code
65162
Product ID
65162-177_6fc4d215-86ac-416e-8e9a-5f84b78ef2db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals
Application
ANDA077880
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65162-177IInactivated by FDA2026-08-07
excluded packagepackage65162-17765162-177-10IInactivated by FDA2026-08-07
excluded packagepackage65162-17765162-177-11IInactivated by FDA2026-08-07
excluded packagepackage65162-17765162-177-50IInactivated by FDA2026-08-07

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 · 88 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 packagepackage65162-177-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65162-177-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65162-177-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65162-177-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65162-177-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65162-177-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65162-177-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65162-177-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65162-177-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65162-177-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65162-177-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65162-177-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65162-177-11cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65162-177-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65162-177-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65162-177-11cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65162-177-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65162-177-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65162-177-11302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65162-177-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65162-177-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65162-177-11ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65162-177-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65162-177-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65162-177-110efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65162-177-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65162-177-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65162-177-11ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65162-177-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65162-177-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65162-177-11367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65162-177-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65162-177-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65162-177-11557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65162-177-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65162-177-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage65162-177-118af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage65162-177-108af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage65162-177-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage65162-177-11834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage65162-177-10834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage65162-177-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage65162-177-111332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage65162-177-101332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage65162-177-501332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077880-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-05
A077880-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-05
A077880-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-05

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2006-06-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2006-06-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2006-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2006-06-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2006-06-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2006-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2006-06-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077880-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2006-06-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077880-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2006-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077880-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2006-06-058072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077880-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077880-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077880-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077880-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077880-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077880-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077880-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077880-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077880-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077880-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077880-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077880-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077880-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077880-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077880-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077880-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077880-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077880-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077880-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077880-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077880-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077880-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077880-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077880-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077880-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077880-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077880-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077880-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077880-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077880-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077880-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077880-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077880-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077880-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077880-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077880-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077880-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077880-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077880-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077880-001AB13f01610625f2…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
65162-177-102021-01-29Metformin Hydrochloride Tablets, USP
65162-177-112021-01-29Metformin Hydrochloride Tablets, USP
65162-177-502021-01-29Metformin Hydrochloride Tablets, USP
65162-177-102019-11-13Metformin Hydrochloride Tablets, USP
65162-177-112019-11-13Metformin Hydrochloride Tablets, USP
65162-177-502019-11-13Metformin Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-177-10Metformin Hydrochloride100 in 1 BOTTLETABLET1009
65162-177-11Metformin Hydrochloride1000 in 1 BOTTLETABLET10009
65162-177-50Metformin Hydrochloride500 in 1 BOTTLETABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-177-10EA - Each65162-1771f4b6520-50c2-42d4-bb80-efef328fe29512013-02-13
65162-177-11EA - Each65162-17774c29123-ee3b-4b8f-adda-52fda76b2e6012013-02-13
65162-177-50EA - Each65162-17741b3bb5b-ad69-4e4b-b101-727e46f8ffb212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE (METFORMIN) TABLET [AMNEAL PHARMACEUTICALS]9
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE (METFORMIN) TABLET [AMNEAL PHARMACEUTICALS]9
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-177METFORMIN HYDROCHLORIDE (METFORMIN) TABLET [AMNEAL PHARMACEUTICALS]9Legacy NDC, 3 package rows20120907_45cc673a-e125-4d76-8013-89a089eb0ae9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0230a3c3-34cf-478b-88c3-4d96e53000182025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077880
application number: ANDA077880
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.c72cfd1a-dce9-43a3-88e2-3cf1d9078b522025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077880
application number: ANDA077880
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCb090b18b-b53c-4c92-892f-d11551cfedc32023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077880
application number: ANDA077880

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN45cc673a-e125-4d76-8013-89a089eb0ae99
861007metFORMIN HCl 500 MG Oral TabletPSN45cc673a-e125-4d76-8013-89a089eb0ae99
861010metFORMIN HCl 850 MG Oral TabletPSN45cc673a-e125-4d76-8013-89a089eb0ae99
861004metformin hydrochloride 1000 MG Oral TabletSCD45cc673a-e125-4d76-8013-89a089eb0ae99
861007metformin hydrochloride 500 MG Oral TabletSCD45cc673a-e125-4d76-8013-89a089eb0ae99
861010metformin hydrochloride 850 MG Oral TabletSCD45cc673a-e125-4d76-8013-89a089eb0ae99
861004metformin HCl 1 GM Oral TabletSY45cc673a-e125-4d76-8013-89a089eb0ae99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65162-177-1065162017710100 in 1 BOTTLEHistorical
65162-177-11651620177111000 in 1 BOTTLEHistorical
65162-177-5065162017750500 in 1 BOTTLEHistorical