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 43.

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-2384e616aacf4f…
2026-09-14 22:38:342026-08A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-2384e616aacf4f…
2026-09-14 22:38:342026-08A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-2384e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078181-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078181-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078181-003AB184e616aacf4f…
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…

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
ndc (product): 71335-0180
ndc (product): 71335-0484
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.58c4261e-e98f-4280-9562-2800956dff142026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1b3c7d74-f80b-4fb1-8dca-66880af5d3fc2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDENorthwind Health Company, LLC3e81a39a-30bb-4d6d-82e1-17d7134365be2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
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
GlimepirideGLIMEPIRIDEProficient Rx LPbeb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LP5a5747ea-cded-49ed-8807-dd3e2a1159e02022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LP68cb4fcd-5bc3-4f53-9085-86df6a4246d62022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68001-179GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-179GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68071-1910GlimepirideGlimepirideNuCare Pharmaceuticals, IANDACurrent
68071-1910GlimepirideGlimepirideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1910GlimepirideGlimepirideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1942GlimepirideGlimepirideNuCare Pharmaceuticals, IANDACurrent
68071-1942GlimepirideGlimepirideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1942GlimepirideGlimepirideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3068GlimepirideGlimepirideNuCare Pharmaceuticals, IANDACurrent
68071-3068GlimepirideGlimepirideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3068GlimepirideGlimepirideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4869GlimepirideGlimepirideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4869GlimepirideGlimepirideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4869GlimepirideGlimepirideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4904GlimepirideGlimepirideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4904GlimepirideGlimepirideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4990GlimepirideGlimepirideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4990GlimepirideGlimepirideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6411GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6411GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6411GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6436GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8066GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8066GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8095GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8095GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0296GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-0296GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-0296GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-0296GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-0296GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-0405GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-0405GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-0405GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-0405GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-0405GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-1639GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-1639GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-2092GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-2412GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-2412GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-2412GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-2412GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-2412GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-2670GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-2670GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-2670GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-2670GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70934-167GlimepirideGlimepirideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-167GlimepirideGlimepirideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-167GlimepirideGlimepirideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-173GlimepirideGlimepirideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-173GlimepirideGlimepirideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-173GlimepirideGlimepirideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-232GlimepirideGlimepirideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-232GlimepirideGlimepirideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-323GlimepirideGlimepirideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-323GlimepirideGlimepirideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0180GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
71335-0180GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
71335-0180GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
71335-0180GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
71335-0484GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
71335-0484GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
71335-0484GlimepirideGlimepirideBryant Ranch PrepackANDACurrent