FDA.reportPublic FDA data

Application 078181

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL1MGNoNo
002GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL2MGNoNo
003GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL4MGNoNo

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
A078181-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2007-08-23
A078181-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2007-08-23
A078181-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2007-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078181-001AB
A078181-002AB
A078181-003AB

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 22:54:322026-06A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23a50c72e98297…
2026-08-01 22:54:322026-06A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23a50c72e98297…
2026-08-01 22:54:322026-06A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078181-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078181-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078181-003AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEBryant Ranch Prepack9e863f84-d6f2-4d61-8250-774569e843532026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.58c4261e-e98f-4280-9562-2800956dff142026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
ndc (product): 43063-587
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1b3c7d74-f80b-4fb1-8dca-66880af5d3fc2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
ndc (product): 43063-630
GlimepirideGLIMEPIRIDENorthwind Health Company, LLC3e81a39a-30bb-4d6d-82e1-17d7134365be2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
ndc (product): 51655-120
GlimepirideGLIMEPIRIDENorthwind Health Company, LLCf2f2d6da-eb40-4290-e053-2a95a90a6ca02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEAccord Healthcare Inc9b74fbac-9e04-4927-9981-1e3dace89c6d2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
ndc (product): 16729-002
ndc (product): 16729-003
ndc (product): 16729-001
GlimepirideGLIMEPIRIDEProficient Rx LPbeb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
ndc (product): 63187-641
GlimepirideGLIMEPIRIDEProficient Rx LP5a5747ea-cded-49ed-8807-dd3e2a1159e02022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
ndc (product): 63187-698
GlimepirideGLIMEPIRIDEProficient Rx LP68cb4fcd-5bc3-4f53-9085-86df6a4246d62022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
ndc (product): 63187-486

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 145 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-001GlimepirideGlimepirideAccord Healthcare IncANDACurrent
16729-001GlimepirideGlimepirideAccord Healthcare IncANDACurrent
16729-002GlimepirideGlimepirideAccord Healthcare IncANDACurrent
16729-002GlimepirideGlimepirideAccord Healthcare IncANDACurrent
16729-003GlimepirideGlimepirideAccord Healthcare IncANDACurrent
16729-003GlimepirideGlimepirideAccord Healthcare IncANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-630GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-630GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-630GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-630GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-630GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1526GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1526GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1526GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1526GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1526GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1987GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1987GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1987GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1987GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-3547GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
51655-120GLIMEPIRIDEGLIMEPIRIDENorthwind PharmaceuticalsANDACurrent
51655-120GlimepirideGlimepirideNorthwind Pharmaceuticals, LLCANDACurrent
51655-120GlimepirideGlimepirideNorthwind Pharmaceuticals, LLCANDACurrent
53217-250GlimepirideGlimepirideAidarex Pharmaceuticals LLCANDACurrent
55700-594GlimepirideGlimepirideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-594GlimepirideGlimepirideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-594GlimepirideGlimepirideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-594GlimepirideGlimepirideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-722GlimepirideGlimepirideQuality Care Products, LLCANDACurrent
55700-722GlimepirideGlimepirideQuality Care Products, LLCANDACurrent
60760-248GlimepirideGlimepirideSt. MaryANDACurrent
60760-248GlimepirideGlimepirideSt. MaryANDACurrent
61919-250GLIMEPIRIDEGLIMEPIRIDEDIRECT RXANDACurrent
61919-250GLIMEPIRIDEGLIMEPIRIDEDIRECT RXANDACurrent
61919-250GLIMEPIRIDEGLIMEPIRIDEDIRECT RXANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDirectRXANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDircet_RxANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDirect_RxANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDirect_RxANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDircet_RxANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDircet_RxANDACurrent
61919-723GLIMEPIRIDEGLIMEPIRIDEDIRECT RXANDACurrent
61919-723GLIMEPIRIDEGLIMEPIRIDEDirect_RxANDACurrent
63187-486GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-486GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-486GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-486GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-641GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-641GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-641GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-698GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-698GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-698GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-698GlimepirideGlimepirideProficient Rx LPANDACurrent
63629-5650GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-5650GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-5650GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
67296-1246GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
67296-1246GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
67296-1246GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
67296-1247GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
67296-1247GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
67296-1247GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
68001-177GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-177GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-177GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-177GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-178GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-178GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-178GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-178GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-179GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-179GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent