FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
43353-982
11-digit product format
433530982
Labeler code
43353
Product ID
43353-982_4900492c-70fa-e5b5-e063-6294a90af743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203769
Marketing category
ANDA
Marketing start
2013-09-11
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203769-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11
A203769-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11
A203769-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11
A203769-004METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE625MGTABLET / ORALAB2026-02-09
A203769-005METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE750MGTABLET / ORALAB2026-02-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A203769-001AB
A203769-002AB
A203769-003AB
A203769-004AB
A203769-005AB

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 · 137 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A203769-004METFORMIN HYDROCHLORIDE625MGTABLET / ORALAB2026-02-0984e616aacf4f…
2026-09-14 22:38:342026-08A203769-005METFORMIN HYDROCHLORIDE750MGTABLET / ORALAB2026-02-0984e616aacf4f…
2026-08-18 06:07:402026-07A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-004METFORMIN HYDROCHLORIDE625MGTABLET / ORALAB2026-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-005METFORMIN HYDROCHLORIDE750MGTABLET / ORALAB2026-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-004METFORMIN HYDROCHLORIDE625MGTABLET / ORALAB2026-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-005METFORMIN HYDROCHLORIDE750MGTABLET / ORALAB2026-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 137 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203769-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203769-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203769-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A203769-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A203769-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A203769-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203769-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203769-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203769-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203769-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203769-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203769-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203769-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203769-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203769-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203769-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203769-001AB1d06236e962d9…

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
Listing expiration
2027-12-31

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 · 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
273d86b0-9d30-48c9-8918-c5e1ececa951Available 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
43353-982-30METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET306
43353-982-53METFORMIN HYDROCHLORIDE60 in 1 BOTTLETABLET606
43353-982-60METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET906
43353-982-70METFORMIN HYDROCHLORIDE120 in 1 BOTTLETABLET1206
43353-982-80METFORMIN HYDROCHLORIDE180 in 1 BOTTLETABLET1806
43353-982-92METFORMIN HYDROCHLORIDE270 in 1 BOTTLETABLET2706
43353-982-94METFORMIN HYDROCHLORIDE360 in 1 BOTTLETABLET3606
43353-982-96METFORMIN HYDROCHLORIDE450 in 1 BOTTLETABLET4506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-982-70EA - Each43353-982a8acab5b-4578-4019-8226-8a3f9d64c2e712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-982METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]5Current NDC, Legacy NDC, 8 package rows20240618_273d86b0-9d30-48c9-8918-c5e1ececa951.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 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.f86bda10-8b25-4125-8bb1-1b5917969ff02023-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack76879512-3ab4-4acf-92e6-bba0fb75dd0e2023-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepacka59327bd-a3ba-417b-9e91-4cd3a941e6402023-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepacka79d2674-071f-4641-9b11-406e02c5530a2023-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd0bee456-c8cd-46a1-acb3-5313a8cddd302022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP738402d6-3700-46b2-a90c-2e8f2c354a392022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack9632456f-57c2-444b-9f43-d9ca862681fe2021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEACI Healthcare USA, Inc.e18b60f9-721e-4db6-9f61-d3437e18faf22020-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN273d86b0-9d30-48c9-8918-c5e1ececa9516
861007metFORMIN HCl 500 MG Oral TabletPSN273d86b0-9d30-48c9-8918-c5e1ececa9516
861010metFORMIN HCl 850 MG Oral TabletPSN273d86b0-9d30-48c9-8918-c5e1ececa9516
861004metformin hydrochloride 1000 MG Oral TabletSCD273d86b0-9d30-48c9-8918-c5e1ececa9516
861007metformin hydrochloride 500 MG Oral TabletSCD273d86b0-9d30-48c9-8918-c5e1ececa9516
861010metformin hydrochloride 850 MG Oral TabletSCD273d86b0-9d30-48c9-8918-c5e1ececa9516
861004metformin HCl 1 GM Oral TabletSY273d86b0-9d30-48c9-8918-c5e1ececa9516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-982-304335309823030 TABLET in 1 BOTTLE (43353-982-30) 30 tablet2014-11-110000-00-00NoNoCurrent
43353-982-534335309825360 TABLET in 1 BOTTLE (43353-982-53) 60 tablet2015-11-160000-00-00NoNoCurrent
43353-982-604335309826090 TABLET in 1 BOTTLE (43353-982-60) 90 tablet2015-05-130000-00-00NoNoCurrent
43353-982-7043353098270120 TABLET in 1 BOTTLE (43353-982-70) 120 tablet2019-05-14NoNoCurrent
43353-982-8043353098280180 TABLET in 1 BOTTLE (43353-982-80) 180 tablet2015-05-120000-00-00NoNoCurrent
43353-982-9243353098292270 TABLET in 1 BOTTLE (43353-982-92) 270 tablet2015-05-120000-00-00NoNoCurrent
43353-982-9443353098294360 TABLET in 1 BOTTLE (43353-982-94) 360 tablet2015-05-120000-00-00NoNoCurrent
43353-982-9643353098296450 TABLET in 1 BOTTLE (43353-982-96) 450 tablet2015-03-280000-00-00NoNoCurrent