FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
65162-178
11-digit product format
651620178
Labeler code
65162
Product ID
65162-178_984302ad-793e-4f35-92da-e5e7f92154f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA078596
Marketing category
ANDA
Marketing start
2009-12-02
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078596-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORAL2008-01-03
A078596-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORAL2008-01-03

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORAL2008-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORAL2008-01-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2008-01-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12008-01-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALABRS2008-01-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078596-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALBX2008-01-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078596-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALBX2008-01-03bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078596-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078596-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078596-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078596-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078596-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078596-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078596-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078596-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078596-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078596-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078596-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078596-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078596-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078596-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078596-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078596-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078596-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078596-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078596-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078596-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078596-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078596-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078596-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078596-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078596-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078596-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078596-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078596-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078596-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078596-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078596-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078596-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078596-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078596-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078596-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078596-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078596-001BX1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078596-002BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078596-001BX1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078596-002BX1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Metformin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
786Z46389EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860975Internal RxNorm lookup
860981Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c01a79e0-f2b7-4d99-857e-bda7f24fe319Available on FDA.report

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
65162-178-03Metformin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE308
65162-178-09Metformin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE908
65162-178-10Metformin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1008
65162-178-11Metformin Hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE10008
65162-178-50Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5008
65162-178-89Metformin Hydrochloride10000 in 1 DRUMTABLET, EXTENDED RELEASE100008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-178-09EA - Each65162-178c7ab7449-1644-4c93-83cf-1dbe72f6191812018-11-06
65162-178-10EA - Each65162-178ef84e5b8-524b-4b85-b263-7fc1032f1c3d12018-11-06
65162-178-11EA - Each65162-178735510bf-1fcb-46e5-9619-ac8ca9f6919412018-11-06
65162-178-50EA - Each65162-178db428f82-40d3-48e7-86e8-23340b0e412512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-178METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 6 package rows20241031_c01a79e0-f2b7-4d99-857e-bda7f24fe319.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmneal Pharmaceuticals NY LLCdc65065b-cba0-46d7-8fb5-3368f3210b4d2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078596
application number: ANDA078596
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC38687872-ca68-4965-b317-637c25ba041e2023-11-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078596
application number: ANDA078596
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC6b8824c0-ece0-4b15-ba71-e893d6d2bfdf2022-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078596
application number: ANDA078596
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmneal Pharmaceuticals LLCc01a79e0-f2b7-4d99-857e-bda7f24fe3192018-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078596
application number: ANDA078596
ndc (product): 65162-178

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNc01a79e0-f2b7-4d99-857e-bda7f24fe3198
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSNc01a79e0-f2b7-4d99-857e-bda7f24fe3198
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDc01a79e0-f2b7-4d99-857e-bda7f24fe3198
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCDc01a79e0-f2b7-4d99-857e-bda7f24fe3198
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYc01a79e0-f2b7-4d99-857e-bda7f24fe3198
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSYc01a79e0-f2b7-4d99-857e-bda7f24fe3198

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-178-036516201780330 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-03) 2009-12-020000-00-00NoNoCurrent
65162-178-096516201780990 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-09) 2009-12-020000-00-00NoNoCurrent
65162-178-1065162017810100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-10) 2009-12-020000-00-00NoNoCurrent
65162-178-11651620178111000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-11) 2009-12-020000-00-00NoNoCurrent
65162-178-5065162017850500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-50) 2009-12-020000-00-00NoNoCurrent
65162-178-896516201788910000 TABLET, EXTENDED RELEASE in 1 DRUM (65162-178-89) 2009-12-020000-00-00NoNoCurrent