Metformin Hydrochloride

Product NDC
63187-332
11-digit product format
631870332
Labeler code
63187
Product ID
63187-332_1b6ac895-7c0d-4464-8a42-a9a16fafcf45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203769
Marketing category
ANDA
Marketing start
2014-02-01
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-332DDiscontinued by firm2026-10-12
excluded packagepackage63187-33263187-332-00DDiscontinued by firm2026-10-12
excluded packagepackage63187-33263187-332-30DDiscontinued by firm2026-10-12
excluded packagepackage63187-33263187-332-60DDiscontinued by firm2026-10-12
excluded packagepackage63187-33263187-332-90DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-332-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-332-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-332-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-332-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-332-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-332-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-332-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-332-60f5e01cc5f278…a2eaf40c39c3…

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.

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-332METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]5Legacy NDC20210116_afcdbfd7-aed1-4f48-9bac-5a1b04323c61.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-332-0063187033200100 TABLET, FILM COATED in 1 BOTTLE (63187-332-00) 2014-03-030000-00-00NoNoCurrent
63187-332-306318703323030 TABLET, FILM COATED in 1 BOTTLE (63187-332-30) 2014-03-030000-00-00NoNoCurrent
63187-332-606318703326060 TABLET, FILM COATED in 1 BOTTLE (63187-332-60) 2014-03-030000-00-00NoNoCurrent
63187-332-906318703329090 TABLET, FILM COATED in 1 BOTTLE (63187-332-90) 2014-03-030000-00-00NoNoCurrent