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 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
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.

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 06:07:402026-07A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-231e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078181-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078181-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078181-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078181-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078181-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078181-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-001AB11e350fbaab3a…

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 · 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