Glimepiride

Product NDC
69543-124
11-digit product format
695430124
Labeler code
69543
Product ID
69543-124_d8f2bca6-5e18-4a1f-b782-9b6e7ba83bc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Virtus Pharmaceuticals
Application
ANDA202112
Marketing category
ANDA
Marketing start
2015-07-14
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69543-124DDiscontinued by firm2026-08-11
excluded packagepackage69543-12469543-124-10DDiscontinued by firm2026-08-11
excluded packagepackage69543-12469543-124-50DDiscontinued by firm2026-08-11

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
A202112-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2013-04-17
A202112-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2013-04-17
A202112-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2013-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202112-001AB
A202112-002AB
A202112-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202112-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202112-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202112-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202112-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202112-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202112-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202112-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202112-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202112-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202112-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-124-10EA - Each69543-124182ddc53-b580-4395-b945-a4aec8bbcbb912015-08-04
69543-124-50EA - Each69543-124d6ce8d0e-dd7d-44b0-88f7-4a4fd70171b712015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GlimepirideACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
GlimepirideACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69543-124GLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]3Legacy NDC20190403_4419ca50-539c-47e8-ab00-dbb45c7c1814.zip

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEPreferred Pharmaceuticals Inc.f69e36b9-4940-4f01-b5ea-59dc66dc1e872026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDECoupler LLC41bf4a72-9288-50a1-e063-6394a90a5e7c2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEREMEDYREPACK INC.c994796e-dd3d-4f40-a8f2-d317f55e34d52025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEREMEDYREPACK INC.95c59026-a2db-4579-b58c-b0a8e12e7f842025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEST. MARY'S MEDICAL PARK PHARMACY35ba31ef-2b90-61c6-e063-6394a90a59ee2025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEA-S Medication Solutions49bf2d48-efa8-487b-b861-0124c3a4c9512025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEBryant Ranch Prepack661b5b13-6334-4965-8dc5-709e190805842025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEA-S Medication Solutions0c25c987-856f-448d-903a-e2c94049b0a72024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEA-S Medication Solutions79ee7533-f75d-4c49-b396-b339654f5c442024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEFlorida Pharmaceutical Products, LLC8ff0de99-272e-4e68-9caf-69f3f146ac292024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEDirect_rx230949fd-563e-8dbf-e063-6394a90ab9b62024-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEA-S Medication Solutions1e5d562e-b3bf-4502-adc8-c89c8818a9bc2024-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEA-S Medication Solutions01196f54-32c8-41a0-b0ed-7968ca5d2fa22024-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDENuCare Pharmaceuticals,Inc.1c335fc7-24d0-5526-e063-6394a90a488e2024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEBryant Ranch Prepack0b12d4ab-fa0c-44d5-888c-265dbb6615612024-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEBryant Ranch Prepackcdeda274-955b-413d-b2d4-b14d94f7d20c2024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-124-1069543012410100 TABLET in 1 BOTTLE (69543-124-10) 100 tablet2015-07-140000-00-00NoNoCurrent
69543-124-5069543012450500 TABLET in 1 BOTTLE (69543-124-50) 500 tablet2015-07-140000-00-00NoNoCurrent