metformin hydrochloride

Product NDC
0185-4416
11-digit product format
001854416
Labeler code
0185
Product ID
0185-4416_e6950b9a-5011-479b-835b-6a6a3af93b9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA076873
Marketing category
ANDA
Marketing start
2004-12-14
Marketing end
2021-07-31
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0185-4416DDiscontinued by firm2026-08-17
excluded packagepackage0185-44160185-4416-01DDiscontinued by firm2026-08-17
excluded packagepackage0185-44160185-4416-05DDiscontinued by firm2026-08-17
excluded packagepackage0185-44160185-4416-75DDiscontinued by firm2026-08-17

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 · 48 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 packagepackage0185-4416-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-4416-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-4416-75d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-4416-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-4416-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-4416-75f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-4416-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-4416-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-4416-752ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-4416-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-4416-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-4416-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-4416-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-4416-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-4416-75cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-4416-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-4416-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-4416-75cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-4416-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-4416-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-4416-75302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-4416-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-4416-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-4416-75ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-4416-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-4416-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-4416-750efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-4416-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-4416-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-4416-75ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-4416-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-4416-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-4416-75367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-4416-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-4416-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-4416-75557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076873-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076873-001AB1

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-143f01610625f2…
2019-09-15 20:21 UTC2019-09A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076873-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12004-12-14e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076873-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076873-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076873-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076873-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076873-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076873-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076873-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076873-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076873-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076873-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076873-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076873-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076873-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076873-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076873-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076873-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076873-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076873-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076873-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076873-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076873-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076873-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A076873-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076873-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076873-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076873-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A076873-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A076873-001AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076873-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076873-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076873-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076873-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076873-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076873-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076873-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A076873-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A076873-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076873-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076873-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076873-001AB11e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-4416-01EA - Each0185-4416c818289f-480b-41ea-ade0-497cc0ad6f4212012-07-24
0185-4416-05EA - Each0185-441625351e85-608a-4c77-894d-4c71f389a9e612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]13
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]13
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-4416-0100185441601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-4416-01) 2004-12-142021-07-31NoNoCurrent
0185-4416-0500185441605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-4416-05) 2004-12-142021-07-31NoNoCurrent
0185-4416-7500185441675750 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-4416-75) 2004-12-142021-07-31NoNoCurrent