FDA.reportPublic FDA data

Metformin hydrochloride

Product NDC
50742-154
Requested package NDC
50742-154-10
11-digit product format
507420154
Labeler code
50742
Product ID
50742-154_70359e5d-2824-46ad-8fe0-253272b5ddb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA090564
Marketing category
ANDA
Marketing start
2014-07-16
Marketing end
2022-02-28
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50742-15450742-154-10DDiscontinued by firm2026-07-31

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
A090564-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22
A090564-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22
A090564-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090564-001AB
A090564-002AB
A090564-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22a50c72e98297…
2026-08-01 22:54:322026-06A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22a50c72e98297…
2026-08-01 22:54:322026-06A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090564-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090564-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A090564-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 26 · 516 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.41408f64-d366-403e-9595-464ab25c6f972026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.68d0b1a6-c99e-42cf-afdf-b71ee73c44242026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9171d369-d35a-40e4-a9ad-26484e66fc5e2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.30658e19-8e6e-49aa-a007-e414224797c52026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
ndc (package): 70518-2833-5
ndc (package): 70518-2833-9
ndc (package): 70518-2833-6
ndc (package): 70518-2833-1
ndc (package): 70518-2833-3
ndc (package): 70518-2833-7
ndc (package): 70518-2833-2
ndc (package): 70518-2833-8
ndc (package): 70518-2833-4
ndc (package): 70518-2833-0
ndc (product): 70518-2833
rxcui: 861007
spl id: 57c46cc3-ef60-bbf1-e063-6294a90a73ac
spl set id: 30658e19-8e6e-49aa-a007-e414224797c5
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.1503bbe4-0ac5-479b-9900-d38e49236bf02026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.e22a8545-86a6-439e-a758-29c4d6ed8bfe2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECardinal Health 107, LLC46cb7e3f-c739-433d-9dbe-427c2d95bef12026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
ndc (package): 55154-4172-0
ndc (product): 55154-4172
rxcui: 861007
spl id: c3c024ed-5f95-4247-ab2f-38439c355d00
spl set id: 46cb7e3f-c739-433d-9dbe-427c2d95bef1
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEChartwell RX, LLC4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Metformin ER 500 mgMETFORMIN ER 500 MGGranules India Ltdb857eccf-b9ff-45ba-8241-f47f5caada2a2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.13235d8e-ac3a-45b4-9c5d-9a9012951dfe2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5aa1c86c-f2c8-49b1-8f81-47b11386c5d32026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
ndc (package): 70518-4698-0
ndc (product): 70518-4698
rxcui: 861007
spl id: 56a5a4eb-f1b9-35f3-e063-6394a90a882a
spl set id: 5aa1c86c-f2c8-49b1-8f81-47b11386c5d3
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limited4ac6d01a-af26-44e7-ae2e-3618de0080aa2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEBryant Ranch Prepackb5ccf5da-cbe1-4009-ba1c-990050838ee92026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEBryant Ranch Prepacka086cc29-cb5d-40d0-a57d-8e91f1aa91582026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLPD-Rx Pharmaceuticals, Inc.fb890205-5d43-41eb-97b2-fb0dcdd3a9502026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
ndc (package): 72789-192-30
ndc (package): 72789-192-21
ndc (package): 72789-192-93
ndc (package): 72789-192-60
ndc (package): 72789-192-20
ndc (product): 72789-192
rxcui: 861007
spl id: 5683dd49-29a1-2b76-e063-6294a90a3c5b
spl set id: fb890205-5d43-41eb-97b2-fb0dcdd3a950
unii: 786Z46389E
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsc603b844-2019-4ef4-8385-7bc3f96a25652026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.d5228e81-9c86-4781-b984-20feaa2ae7792026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC5647230e-5bc6-1802-e063-6394a90a27242026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsb55ee3d9-7f0b-4dd9-9213-fbc69f09f5672026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limitedfc466c46-abaa-4675-aef2-4b1a1adfd9122026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-154-01EA - Each50742-1541cdae735-5ad3-40c6-b956-0c8a57609bf912014-08-01
50742-154-05EA - Each50742-1546b8ab3b8-2234-4e5b-b3de-5d51f35489b412014-08-01
50742-154-10EA - Each50742-1541772506b-835b-4b32-a302-6483a233805f12014-08-01
50742-154-90EA - Each50742-154fc7dd77b-8591-428f-b9c0-3d822a40665612015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metformin hydrochlorideACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2
metforminACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2
hypromellose 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6METFORMIN HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2
povidone K30INACTIVE INGREDIENTU725QWY32XMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2
povidone K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2
starch, cornINACTIVE INGREDIENTO8232NY3SJMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2
triacetinINACTIVE INGREDIENTXHX3C3X673METFORMIN HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-154-10507420154101000 TABLET, FILM COATED in 1 BOTTLE (50742-154-10) 2014-07-162022-02-28NoNoCurrent