FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
12634-789
Requested package NDC
12634-789-61
11-digit product format
126340789
Labeler code
12634
Product ID
12634-789_46625c1e-8ee1-4178-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotheca Inc.
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage12634-78912634-789-61IInactivated by FDA2026-11-10

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 · 16 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-0179d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A091184-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091184-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091184-001AB179d66fd596c7…

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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-789-00Metformin Hydrochloride10 in 1 BOTTLETABLET, FILM COATED102
12634-789-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
12634-789-09Metformin Hydrochloride35 in 1 BOTTLETABLET, FILM COATED352
12634-789-12Metformin Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1202
12634-789-18Metformin Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1802
12634-789-40Metformin Hydrochloride40 in 1 BOTTLETABLET, FILM COATED402
12634-789-42Metformin Hydrochloride42 in 1 BOTTLETABLET, FILM COATED422
12634-789-45Metformin Hydrochloride45 in 1 BOTTLETABLET, FILM COATED452
12634-789-50Metformin Hydrochloride50 in 1 BOTTLETABLET, FILM COATED502
12634-789-52Metformin Hydrochloride12 in 1 BLISTER PACKTABLET, FILM COATED122
12634-789-54Metformin Hydrochloride14 in 1 BLISTER PACKTABLET, FILM COATED142
12634-789-57Metformin Hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED202
12634-789-59Metformin Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED302
12634-789-60Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
12634-789-61Metformin Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
12634-789-63Metformin Hydrochloride3 in 1 BLISTER PACKTABLET, FILM COATED32
12634-789-66Metformin Hydrochloride6 in 1 BLISTER PACKTABLET, FILM COATED62
12634-789-67Metformin Hydrochloride7 in 1 BLISTER PACKTABLET, FILM COATED72
12634-789-69Metformin Hydrochloride9 in 1 BLISTER PACKTABLET, FILM COATED92
12634-789-71Metformin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
12634-789-74Metformin Hydrochloride24 in 1 BOTTLETABLET, FILM COATED242
12634-789-78Metformin Hydrochloride28 in 1 BOTTLETABLET, FILM COATED282
12634-789-79Metformin Hydrochloride25 in 1 BOTTLETABLET, FILM COATED252
12634-789-80Metformin Hydrochloride20 in 1 BOTTLETABLET, FILM COATED202
12634-789-81Metformin Hydrochloride21 in 1 BOTTLETABLET, FILM COATED212
12634-789-82Metformin Hydrochloride12 in 1 BOTTLETABLET, FILM COATED122
12634-789-84Metformin Hydrochloride14 in 1 BOTTLETABLET, FILM COATED142
12634-789-85Metformin Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152
12634-789-90Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902
12634-789-91Metformin Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
12634-789-92Metformin Hydrochloride2 in 1 BOTTLETABLET, FILM COATED22
12634-789-93Metformin Hydrochloride3 in 1 BOTTLETABLET, FILM COATED32
12634-789-94Metformin Hydrochloride4 in 1 BOTTLETABLET, FILM COATED42
12634-789-95Metformin Hydrochloride5 in 1 BOTTLETABLET, FILM COATED52
12634-789-96Metformin Hydrochloride6 in 1 BOTTLETABLET, FILM COATED62
12634-789-97Metformin Hydrochloride7 in 1 BOTTLETABLET, FILM COATED72
12634-789-98Metformin Hydrochloride8 in 1 BOTTLETABLET, FILM COATED82
12634-789-99Metformin Hydrochloride9 in 1 BOTTLETABLET, FILM COATED92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-789METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APOTHECA INC.]2Legacy NDC, 38 package rows20170118_4661d307-78b2-2f5b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN4661d307-78b2-2f5b-e054-00144ff88e882
861007metFORMIN HCl 500 MG Oral TabletPSN4661d307-78b2-2f5b-e054-00144ff88e882
861010metFORMIN HCl 850 MG Oral TabletPSN4661d307-78b2-2f5b-e054-00144ff88e882
861004metformin hydrochloride 1000 MG Oral TabletSCD4661d307-78b2-2f5b-e054-00144ff88e882
861007metformin hydrochloride 500 MG Oral TabletSCD4661d307-78b2-2f5b-e054-00144ff88e882
861010metformin hydrochloride 850 MG Oral TabletSCD4661d307-78b2-2f5b-e054-00144ff88e882
861004metformin HCl 1 GM Oral TabletSY4661d307-78b2-2f5b-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
12634-789-611263407896110 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-61) 2011-01-310000-00-00NoNoCurrent