Glimepiride

Product NDC
42571-100
11-digit product format
425710100
Labeler code
42571
Product ID
42571-100_34e9a6b6-450b-7d20-e063-6294a90ac831
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA091220
Marketing category
ANDA
Marketing start
2013-06-13
Substance
GLIMEPIRIDE
Active strength
1 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 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091220-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2012-06-29
A091220-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2012-06-29
A091220-003GLIMEPIRIDEGLIMEPIRIDE3MGTABLET / ORAL2012-06-29
A091220-004GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2012-06-29
A091220-005GLIMEPIRIDEGLIMEPIRIDE6MGTABLET / ORAL2012-06-29
A091220-006GLIMEPIRIDEGLIMEPIRIDE8MGTABLET / ORALAB2012-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A091220-001AB
A091220-002AB
A091220-004AB
A091220-006AB

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 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-2903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091220-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091220-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091220-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091220-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091220-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091220-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091220-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091220-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091220-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091220-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091220-006AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091220-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091220-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091220-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091220-006AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE1 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
153842Internal RxNorm lookup
199245Internal RxNorm lookup
199246Internal RxNorm lookup
199247Internal RxNorm lookup
1361493Internal RxNorm lookup
1361495Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
60e9397e-83b9-489e-9683-6f87e458bbaaAvailable 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
42571-100-01Glimepiride100 in 1 BOTTLETABLET10091233
42571-100-05Glimepiride500 in 1 BOTTLETABLET50091233

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-100-01EA - Each42571-100ea561710-c049-44bc-bb09-bf5d3c9b7e2512013-04-01
42571-100-05EA - Each42571-10054369bac-a4d8-46d2-8b9c-22de7a016a9612013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
POVIDONE K30INACTIVE INGREDIENTU725QWY32XGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-100GLIMEPIRIDE (GLIMEPIRIDE) TABLET [MICRO LABS LIMITED]91233Current NDC, Legacy NDC, 2 package rows20250513_60e9397e-83b9-489e-9683-6f87e458bbaa.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEBryant Ranch Prepack62780d2e-083d-4bcb-99ff-1b1b4ade60d92026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220
GlimepirideGLIMEPIRIDEBluePoint Laboratoriesa01b0466-13f5-4c47-ae55-c5f1527d94142025-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220
GlimepirideGLIMEPIRIDEBryant Ranch Prepackd4513181-4558-4d9a-851b-acf7e3eda25a2025-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220
GlimepirideGLIMEPIRIDEMicro Labs Limited60e9397e-83b9-489e-9683-6f87e458bbaa2025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220
ndc (product): 42571-100
Glimepiride 3 mgGLIMEPIRIDELifsa Drugs LLC51157849-7990-4a8b-ae50-eda1baf93cfa2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220
GlimepirideGLIMEPIRIDENCS HealthCare of KY, Inc dba Vangard Labs669a67c2-2f97-4b7e-8bba-83a015e0fa942020-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
199246glimepiride 2 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
153842glimepiride 3 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
199247glimepiride 4 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
1361493glimepiride 6 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
1361495glimepiride 8 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
199245glimepiride 1 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
199246glimepiride 2 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
153842glimepiride 3 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
199247glimepiride 4 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
1361493glimepiride 6 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
1361495glimepiride 8 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
199245glimepiride 1 MG Oral TabletPSNd4513181-4558-4d9a-851b-acf7e3eda25a104
199245glimepiride 1 MG Oral TabletSCDd4513181-4558-4d9a-851b-acf7e3eda25a104
199245glimepiride 1 MG Oral TabletPSN669a67c2-2f97-4b7e-8bba-83a015e0fa941
199246glimepiride 2 MG Oral TabletPSN669a67c2-2f97-4b7e-8bba-83a015e0fa941
199247glimepiride 4 MG Oral TabletPSN669a67c2-2f97-4b7e-8bba-83a015e0fa941
199245glimepiride 1 MG Oral TabletSCD669a67c2-2f97-4b7e-8bba-83a015e0fa941
199246glimepiride 2 MG Oral TabletSCD669a67c2-2f97-4b7e-8bba-83a015e0fa941
199247glimepiride 4 MG Oral TabletSCD669a67c2-2f97-4b7e-8bba-83a015e0fa941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-100-0142571010001100 TABLET in 1 BOTTLE (42571-100-01) 100 tablet2013-06-130000-00-00NoNoCurrent
42571-100-0542571010005500 TABLET in 1 BOTTLE (42571-100-05) 500 tablet2013-06-130000-00-00NoNoCurrent