FDA.reportPublic FDA data

Application 077095

Type
ANDA
Sponsor
AUROBINDO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL850MGNoNo
003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL1GMNoNo

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
A077095-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14
A077095-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14
A077095-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077095-001AB
A077095-002AB
A077095-003AB

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 22:54:322026-06A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14a50c72e98297…
2026-08-01 22:54:322026-06A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14a50c72e98297…
2026-08-01 22:54:322026-06A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077095-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077095-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077095-003AB1a50c72e98297…

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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limited4ac6d01a-af26-44e7-ae2e-3618de0080aa2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
ndc (product): 65862-008
ndc (product): 65862-009
ndc (product): 65862-010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limitedfc466c46-abaa-4675-aef2-4b1a1adfd9122026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5d8d654a-9bb4-4c87-ab43-c21c4e8747082026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
ndc (product): 70518-3130
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.073cf6d9-7142-4d8b-898e-174c62a1f76f2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
ndc (product): 70518-1149
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs0448c618-2f0d-4ed3-866f-74b413cf902d2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1d7556eb-82b4-4085-b0b1-dc061b216feb2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCdb113f46-6fac-9005-e053-2995a90a017a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3d450933-8d9d-27de-e063-6294a90ae6d92025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3ab4efb6-bd30-2583-e063-6294a90a415b2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions23aa50c5-28fe-4322-b5c6-1f1c48409b162025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
ndc (product): 50090-2173
ndc (product): 50090-2177
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC390c3bdf-bfaf-203e-e063-6394a90a7d202025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs23aa0072-365c-4d13-9aa7-ae23f7e00ee42024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
ndc (product): 0615-8105
ndc (product): 0615-7982
ndc (product): 0615-8015
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f62024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsafb183f6-a13c-4f00-82d5-9fe336173d342024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP1b9b6db9-1bac-4252-a03c-18dc0271f05f2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
ndc (product): 63187-238
ndc (product): 63187-239

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 68 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-1979Metformin HydrochlorideMetformin HydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
0615-7982Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7982Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7982Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8015Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8015Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8015Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8105Metformin HydrochorideMetforminNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8105Metformin HydrochorideMetforminNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8105Metformin HydrochorideMetforminNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
35356-886Metformin HydrochlorideMetformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-886Metformin HydrochlorideMetformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-886Metformin HydrochlorideMetformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-922Metformin HydrochlorideMetformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-922Metformin HydrochlorideMetformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
42708-039Metformin HydrochlorideMetformin HydrochlorideQPharma IncANDACurrent
42708-039Metformin HydrochlorideMetformin HydrochlorideQPharma IncANDACurrent
42708-040Metformin HydrochlorideMetformin HydrochlorideQPharma IncANDACurrent
42708-040Metformin HydrochlorideMetformin HydrochlorideQPharma IncANDACurrent
43353-114Metformin HydrochlorideMetformin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
49999-106Metformin HydrochlorideMetformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-106Metformin HydrochlorideMetformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-106Metformin HydrochlorideMetformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-2173Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2173Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2177Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2177Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
53808-0459Metformin HydrochlorideMetformin HydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0848Metformin HydrochlorideMetformin HydrochlorideState of Florida DOH Central PharmacyANDACurrent
63187-238Metformin HydrochlorideMetformin HydrochlorideProficient Rx LPANDACurrent
63187-238Metformin HydrochlorideMetformin HydrochlorideProficient Rx LPANDACurrent
63187-239Metformin HydrochlorideMetformin HydrochlorideProficient Rx LPANDACurrent
63187-239Metformin HydrochlorideMetformin HydrochlorideProficient Rx LPANDACurrent
63629-6529Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
63629-6530Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
63629-6530Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
65862-008Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-008Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-008Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-008Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-009Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-009Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-009Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-009Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-010Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-010Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-010Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-010Metformin HydrochlorideMetformin HydrochlorideAurobindo Pharma LimitedANDACurrent
67296-0559Metformin HydrochlorideMetformin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0700Metformin HydrochlorideMetformin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0700Metformin HydrochlorideMetformin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0700Metformin HydrochlorideMetformin HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-3212Metformin HydrochlorideMetformin HydrochlorideNuCare Pharmarmaceuticals, Inc.ANDACurrent
68071-3212Metformin HydrochlorideMetformin HydrochlorideNuCare Pharmarmaceuticals, Inc.ANDACurrent
68645-300Metformin HydrochlorideMetformin HydrochlorideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-300Metformin HydrochlorideMetformin HydrochlorideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-300Metformin HydrochlorideMetformin HydrochlorideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-300Metformin HydrochlorideMetformin HydrochlorideLegacy Pharmaceutical Packaging, LLCANDACurrent
70518-1149Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1149Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1149Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1149Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3130Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3130Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-066Metformin HydrochlorideMetformin HydrochlorideDenton Pharma, Inc.ANDACurrent
70934-066Metformin HydrochlorideMetformin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-066Metformin HydrochlorideMetformin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71455-104METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEUNYTER ENTERPRISESANDACurrent