FDA.reportPublic FDA data

Metformin hydrochloride

Product NDC
33342-141
11-digit product format
333420141
Labeler code
33342
Product ID
33342-141_3ce6010c-10dd-4e6f-9517-d71c0489a7c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA205330
Marketing category
ANDA
Marketing start
2017-11-01
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205330-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-31
A205330-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-31
A205330-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-31

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205330-002METFORMIN HYDROCHLORIDE850MGTABLET / ORAL2017-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205330-003METFORMIN HYDROCHLORIDE1GMTABLET / ORAL2017-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205330-001METFORMIN HYDROCHLORIDE500MGTABLET / ORAL2017-10-311e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A205330-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205330-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205330-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A205330-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A205330-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A205330-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205330-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A205330-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A205330-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205330-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A205330-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A205330-003AB1ea99ee380514…

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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860975Internal RxNorm lookup
860981Internal RxNorm lookup
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
623b3bc6-1b07-4a04-bc7a-7fc695adf063Available 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
33342-141-10Metformin hydrochloride90 in 1 BOTTLETABLET, FILM COATED906
33342-141-11Metformin hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
33342-141-44Metformin hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10006
33342-141-10Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
33342-141-11Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
33342-141-44Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-141METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 3 package rows20230204_623b3bc6-1b07-4a04-bc7a-7fc695adf063.zip
33342-141METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, Legacy NDC, 3 package rows20180216_b8f22f07-c6b2-4d0d-85c5-573bc6f0d1b0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEMacleods Pharmaceuticals Limited623b3bc6-1b07-4a04-bc7a-7fc695adf0632023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205330
application number: ANDA205330
ndc (product): 33342-141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN623b3bc6-1b07-4a04-bc7a-7fc695adf0636
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN623b3bc6-1b07-4a04-bc7a-7fc695adf0636
861007metFORMIN HCl 500 MG Oral TabletPSN623b3bc6-1b07-4a04-bc7a-7fc695adf0636
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN623b3bc6-1b07-4a04-bc7a-7fc695adf0636
861010metFORMIN HCl 850 MG Oral TabletPSN623b3bc6-1b07-4a04-bc7a-7fc695adf0636
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD623b3bc6-1b07-4a04-bc7a-7fc695adf0636
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD623b3bc6-1b07-4a04-bc7a-7fc695adf0636
861004metformin hydrochloride 1000 MG Oral TabletSCD623b3bc6-1b07-4a04-bc7a-7fc695adf0636
861007metformin hydrochloride 500 MG Oral TabletSCD623b3bc6-1b07-4a04-bc7a-7fc695adf0636
861010metformin hydrochloride 850 MG Oral TabletSCD623b3bc6-1b07-4a04-bc7a-7fc695adf0636
861004metformin HCl 1 GM Oral TabletSY623b3bc6-1b07-4a04-bc7a-7fc695adf0636
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY623b3bc6-1b07-4a04-bc7a-7fc695adf0636
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY623b3bc6-1b07-4a04-bc7a-7fc695adf0636
861004metFORMIN HCl 1000 MG Oral TabletPSNb8f22f07-c6b2-4d0d-85c5-573bc6f0d1b01
861007metFORMIN HCl 500 MG Oral TabletPSNb8f22f07-c6b2-4d0d-85c5-573bc6f0d1b01
861010metFORMIN HCl 850 MG Oral TabletPSNb8f22f07-c6b2-4d0d-85c5-573bc6f0d1b01
861004metformin hydrochloride 1000 MG Oral TabletSCDb8f22f07-c6b2-4d0d-85c5-573bc6f0d1b01
861007metformin hydrochloride 500 MG Oral TabletSCDb8f22f07-c6b2-4d0d-85c5-573bc6f0d1b01
861010metformin hydrochloride 850 MG Oral TabletSCDb8f22f07-c6b2-4d0d-85c5-573bc6f0d1b01
861004metformin HCl 1 GM Oral TabletSYb8f22f07-c6b2-4d0d-85c5-573bc6f0d1b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-141-103334201411090 TABLET, FILM COATED in 1 BOTTLE (33342-141-10) 2017-11-01NoNoCurrent
33342-141-1133342014111100 TABLET, FILM COATED in 1 BOTTLE (33342-141-11) 2017-11-01NoNoCurrent
33342-141-44333420141441000 TABLET, FILM COATED in 1 BOTTLE (33342-141-44) 2017-11-01NoNoCurrent