Metformin Hydrochloride

Product NDC
50090-2635
11-digit product format
500902635
Labeler code
50090
Product ID
50090-2635_24ac6c40-f481-452c-8488-bdb184a7c426
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091184
Marketing category
ANDA
Marketing start
2011-01-31
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct50090-2635DDiscontinued by firm2026-11-13
excluded packagepackage50090-263550090-2635-0DDiscontinued by firm2026-11-13
excluded packagepackage50090-263550090-2635-2DDiscontinued by firm2026-11-13
excluded packagepackage50090-263550090-2635-3DDiscontinued by firm2026-11-13
excluded packagepackage50090-263550090-2635-4DDiscontinued by firm2026-11-13
excluded packagepackage50090-263550090-2635-5DDiscontinued by firm2026-11-13

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 packagepackage50090-2635-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2635-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2635-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2635-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2635-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2635-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2635-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2635-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2635-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2635-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2635-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2635-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2635-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2635-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2635-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2635-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2635-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2635-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2635-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2635-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2635-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2635-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2635-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2635-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2635-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2635-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2635-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2635-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2635-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2635-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2635-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2635-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2635-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2635-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2635-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2635-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2635-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2635-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2635-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2635-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2635-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2635-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2635-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2635-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2635-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2635-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2635-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2635-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2635-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2635-4ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
A091184-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01
A091184-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01
A091184-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A091184-001AB
A091184-002AB
A091184-003AB

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 · 135 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-11-14 07:37:172026-10A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01d4dbc9d85df4…
2026-11-14 07:37:172026-10A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01d4dbc9d85df4…
2026-11-14 07:37:172026-10A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01d4dbc9d85df4…
2026-10-15 13:18:302026-09A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01c2088c7a36db…
2026-10-15 13:18:302026-09A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01c2088c7a36db…
2026-10-15 13:18:302026-09A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01c2088c7a36db…
2026-09-14 22:38:342026-08A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-0184e616aacf4f…
2026-08-18 06:07:402026-07A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-11-14 07:37:172026-10A091184-001AB1d4dbc9d85df4…
2026-11-14 07:37:172026-10A091184-002AB1d4dbc9d85df4…
2026-11-14 07:37:172026-10A091184-003AB1d4dbc9d85df4…
2026-10-15 13:18:302026-09A091184-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091184-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091184-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A091184-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A091184-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A091184-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A091184-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091184-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091184-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091184-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091184-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091184-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091184-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091184-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091184-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091184-001AB1d06236e962d9…

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
50090-2635-0EA - Each50090-2635549f30c4-266b-45ff-8dcd-57abb35d8daa12019-06-19
50090-2635-2EA - Each50090-263527550c58-09d1-4400-8e58-37a7966a31c712019-05-02
50090-2635-3EA - Each50090-2635c6a07fbb-642a-4a17-b011-1eb2f7c9ff3f12019-05-02
50090-2635-5EA - Each50090-2635216d9995-e61e-4fe9-b52f-83f1e3a97c6a12019-05-02