FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
23155-841
11-digit product format
231550841
Labeler code
23155
Product ID
23155-841_5de825b4-d3e9-474d-9f17-ceed2d4ea87c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA213320
Marketing category
ANDA
Marketing start
2023-01-19
Marketing end
2027-09-30
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213320-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-03
A213320-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-03
A213320-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213320-001AB
A213320-002AB
A213320-003AB

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 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-0384e616aacf4f…
2026-09-14 22:38:342026-08A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-0384e616aacf4f…
2026-09-14 22:38:342026-08A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-0384e616aacf4f…
2026-08-18 06:07:402026-07A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-03caaa826d4ba7…
2026-08-18 06:07:402026-07A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-03caaa826d4ba7…
2026-08-18 06:07:402026-07A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213320-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2021-12-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213320-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2021-12-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213320-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2021-12-03301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213320-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213320-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213320-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A213320-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213320-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213320-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213320-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213320-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213320-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213320-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213320-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213320-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213320-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213320-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213320-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213320-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213320-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213320-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213320-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213320-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213320-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213320-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213320-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213320-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213320-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213320-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213320-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213320-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213320-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213320-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213320-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213320-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213320-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213320-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213320-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213320-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213320-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213320-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213320-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213320-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
METFORMIN HYDROCHLORIDE

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 · 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
b63bfafa-db4c-4fb8-84cd-ff73a5e7d320Available 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
23155-841-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET1004
23155-841-05METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET5004
23155-841-10METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-841-01EA - Each23155-84165f1e93e-9afd-4246-8080-82a01565cab212023-04-07
23155-841-05EA - Each23155-84155b1e41a-5cce-4964-a23f-da9f1d5c76c312023-04-07
23155-841-10EA - Each23155-841e1dc4149-285d-4429-a12c-7116bcae062d12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-841METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]3Current NDC, 3 package rows20230419_b63bfafa-db4c-4fb8-84cd-ff73a5e7d320.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.289dc8ec-42c8-1d09-e063-6394a90a97f02024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213320
application number: ANDA213320
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.0710e208-5b2c-3c72-e063-6394a90a4dac2024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213320
application number: ANDA213320
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack6a9ab61a-a5d0-41ef-b528-59eac6b4cfe62024-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213320
application number: ANDA213320
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.1182bf60-3578-a0ed-e063-6394a90aa50f2024-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213320
application number: ANDA213320

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSNb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861007metFORMIN HCl 500 MG Oral TabletPSN0710e208-5b2c-3c72-e063-6394a90a4dac4
861007metFORMIN HCl 500 MG Oral TabletPSNb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861010metFORMIN HCl 850 MG Oral TabletPSNb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861004metformin hydrochloride 1000 MG Oral TabletSCDb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861007metformin hydrochloride 500 MG Oral TabletSCD0710e208-5b2c-3c72-e063-6394a90a4dac4
861007metformin hydrochloride 500 MG Oral TabletSCDb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861010metformin hydrochloride 850 MG Oral TabletSCDb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861004metformin HCl 1 GM Oral TabletSYb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861007metFORMIN HCl 500 MG Oral TabletPSN2ffeb25a-76a9-01e6-e063-6394a90ae3322
861007metFORMIN HCl 500 MG Oral TabletPSN5073c482-952c-400c-afff-64380f133bc82
861007metformin hydrochloride 500 MG Oral TabletSCD5073c482-952c-400c-afff-64380f133bc82
861007metformin hydrochloride 500 MG Oral TabletSCD2ffeb25a-76a9-01e6-e063-6394a90ae3322
861007metFORMIN HCl 500 MG Oral TabletPSN6a9ab61a-a5d0-41ef-b528-59eac6b4cfe61
861007metFORMIN HCl 500 MG Oral TabletPSN289dc8ec-42c8-1d09-e063-6394a90a97f01
861007metFORMIN HCl 500 MG Oral TabletPSN262da18b-c2bb-0232-e063-6294a90a39f31
861007metformin hydrochloride 500 MG Oral TabletSCD6a9ab61a-a5d0-41ef-b528-59eac6b4cfe61
861007metformin hydrochloride 500 MG Oral TabletSCD289dc8ec-42c8-1d09-e063-6394a90a97f01
861007metformin hydrochloride 500 MG Oral TabletSCD262da18b-c2bb-0232-e063-6294a90a39f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-841-0123155084101100 TABLET in 1 BOTTLE (23155-841-01) 100 tablet2023-01-192027-09-30NoNoHistorical
23155-841-0523155084105500 TABLET in 1 BOTTLE (23155-841-05) 500 tablet2023-01-192026-10-31NoNoHistorical
23155-841-10231550841101000 TABLET in 1 BOTTLE (23155-841-10) 1000 tablet2023-08-302027-09-30NoNoHistorical