Glimepiride

Product NDC
50090-6322
11-digit product format
500906322
Labeler code
50090
Product ID
50090-6322_f6d891ed-a372-4f20-b4d3-a77f3af53d71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202759
Marketing category
ANDA
Marketing start
2012-06-29
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A202759-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2012-06-29
A202759-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2012-06-29
A202759-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2012-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202759-001AB
A202759-002AB
A202759-003AB

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 UTC2026-02A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-298072bd15b7f6…

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 UTC2026-02A202759-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202759-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202759-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202759-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202759-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202759-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202759-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202759-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202759-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202759-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202759-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202759-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202759-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Glimepiride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6KY687524KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199247Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a11680ba-2750-43ab-a1b1-a52ebe3e139fAvailable on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6322-0Glimepiride30 in 1 BOTTLETABLET303
50090-6322-1Glimepiride100 in 1 BOTTLETABLET1003
50090-6322-2Glimepiride60 in 1 BOTTLETABLET603
50090-6322-3Glimepiride90 in 1 BOTTLETABLET903
50090-6322-4Glimepiride180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6322-0EA - Each50090-6322d8776c79-017f-4a41-a2ee-f77cb15fb1b812023-02-06
50090-6322-1EA - Each50090-632225485073-8362-4bda-953e-f01955ea6ea612023-02-06
50090-6322-2EA - Each50090-63227959c83d-25d7-473d-ad9c-0a4b56b04c5312023-02-06
50090-6322-3EA - Each50090-63228176d336-f527-43a5-ada5-8db5c386b9c912023-02-06
50090-6322-4EA - Each50090-632214490013-f258-4fff-98a7-85dc565bb7aa12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6322GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 5 package rows20230907_a11680ba-2750-43ab-a1b1-a52ebe3e139f.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDESt. Mary's Medical Park Pharmacyfc9d8495-184c-3af1-e053-6394a90a5e292026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEPreferred Pharmaceuticals Inc.744a5cca-7863-491a-b43a-1b649791702c2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEBryant Ranch Prepack248c3cb3-4501-4b85-bd1d-0624b6afda2c2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEBryant Ranch Prepack90d675cb-6def-49a3-b8b4-229f19d6b6172026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEAurobindo Pharma Limited28eefc95-d92e-4555-b6c5-2933860b06102026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1450f455-a14a-4f9b-b3aa-dae49ea0c1862026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEProficient Rx LPdbed06f9-7758-4c96-9af0-1ed6103db7df2026-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEProficient Rx LPe12ab052-e3d6-4246-b727-f1e3f9057f092026-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDERising Pharma Holdings, Inc.48ada723-8144-497d-afd6-a8c52a1dd3ff2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEA-S Medication Solutionsb6ce0eea-149d-4aed-a615-0b1c8f3f6a8e2025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDENorthwind Health Company, LLC10a36c79-1b24-46b7-e063-6294a90a8dca2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEA-S Medication Solutions489dc098-0ac7-4f8e-b258-326229539c7c2025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEA-S Medication Solutionsbe7175ae-ba53-45b8-9554-e4f4ebf568832025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEDirect_Rxfd26934e-daea-f47b-e053-6394a90a4bc62025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEA-S Medication Solutionsa11680ba-2750-43ab-a1b1-a52ebe3e139f2023-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
ndc (product): 50090-6322
GlimepirideGLIMEPIRIDEA-S Medication Solutionse8da2484-43a7-4dcb-84d5-d84596feb9f62023-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEProficient Rx LP8f687fa6-54eb-4556-8ea6-aafec49a87d12023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSNa11680ba-2750-43ab-a1b1-a52ebe3e139f3
199247glimepiride 4 MG Oral TabletSCDa11680ba-2750-43ab-a1b1-a52ebe3e139f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6322-05009063220030 TABLET in 1 BOTTLE (50090-6322-0) 30 tablet2023-01-100000-00-00NoNoCurrent
50090-6322-150090632201100 TABLET in 1 BOTTLE (50090-6322-1) 100 tablet2023-01-100000-00-00NoNoCurrent
50090-6322-25009063220260 TABLET in 1 BOTTLE (50090-6322-2) 60 tablet2023-01-100000-00-00NoNoCurrent
50090-6322-35009063220390 TABLET in 1 BOTTLE (50090-6322-3) 90 tablet2023-01-100000-00-00NoNoCurrent
50090-6322-450090632204180 TABLET in 1 BOTTLE (50090-6322-4) 180 tablet2023-01-100000-00-00NoNoCurrent