FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
53746-220
11-digit product format
537460220
Labeler code
53746
Product ID
53746-220_87735a77-fc44-4fb2-b8f4-1dc44d13ad0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA077880
Marketing category
ANDA
Marketing start
2012-12-17
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 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 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE1000 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861004Internal RxNorm lookup
861007Internal RxNorm lookup
861010Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b090b18b-b53c-4c92-892f-d11551cfedc3Available 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
53746-220-01Metformin Hydrochloride100 in 1 BOTTLETABLET10013
53746-220-05Metformin Hydrochloride500 in 1 BOTTLETABLET50013
53746-220-10Metformin Hydrochloride1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-220-01EA - Each53746-22005e7ad79-5438-4552-b344-884ae8494d1412013-12-02
53746-220-05EA - Each53746-2207b0efb61-9614-42a9-9064-f40b08acb0c212013-12-02
53746-220-10EA - Each53746-220f6c85553-450b-4e4f-8351-83e34d378d4012013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]7
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]7
ACACIAINACTIVE INGREDIENT5C5403N26OMETFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]7
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMETFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]7
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
ACACIAINACTIVE INGREDIENT5C5403N26OMETFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMETFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-220METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Current NDC, Legacy NDC, 3 package rows20240420_b090b18b-b53c-4c92-892f-d11551cfedc3.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
ndc (product): 53746-220

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSNc72cfd1a-dce9-43a3-88e2-3cf1d9078b5218
861004metformin hydrochloride 1000 MG Oral TabletSCDc72cfd1a-dce9-43a3-88e2-3cf1d9078b5218
861004metformin HCl 1 GM Oral TabletSYc72cfd1a-dce9-43a3-88e2-3cf1d9078b5218
861004metFORMIN HCl 1000 MG Oral TabletPSNb090b18b-b53c-4c92-892f-d11551cfedc313
861007metFORMIN HCl 500 MG Oral TabletPSNb090b18b-b53c-4c92-892f-d11551cfedc313
861010metFORMIN HCl 850 MG Oral TabletPSNb090b18b-b53c-4c92-892f-d11551cfedc313
861004metformin hydrochloride 1000 MG Oral TabletSCDb090b18b-b53c-4c92-892f-d11551cfedc313
861007metformin hydrochloride 500 MG Oral TabletSCDb090b18b-b53c-4c92-892f-d11551cfedc313
861010metformin hydrochloride 850 MG Oral TabletSCDb090b18b-b53c-4c92-892f-d11551cfedc313
861004metformin HCl 1 GM Oral TabletSYb090b18b-b53c-4c92-892f-d11551cfedc313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-220-0153746022001100 TABLET in 1 BOTTLE (53746-220-01) 100 tablet2012-12-170000-00-00NoNoCurrent
53746-220-0553746022005500 TABLET in 1 BOTTLE (53746-220-05) 500 tablet2012-12-170000-00-00NoNoCurrent
53746-220-10537460220101000 TABLET in 1 BOTTLE (53746-220-10) 1000 tablet2012-12-170000-00-00NoNoCurrent