FDA.reportPublic FDA data

Glimepiride

Product NDC
65862-580
Requested package NDC
65862-580-49
11-digit product format
658620580
Labeler code
65862
Product ID
65862-580_cb22d2cd-964e-4ce6-8647-2abe0426b570
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202759
Marketing category
ANDA
Marketing start
2012-06-29
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-58065862-580-49UNFINISHEDActive or certified unfinished drug listing2026-07-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29a50c72e98297…
2026-08-01 22:54:322026-06A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29a50c72e98297…
2026-08-01 22:54:322026-06A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202759-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202759-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202759-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 65862-580
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
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

Additional Listing Data#

Finished product
Yes
Brand name base
Glimepiride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE2 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199245Internal RxNorm lookup
199246Internal RxNorm lookup
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
28eefc95-d92e-4555-b6c5-2933860b0610Available 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
65862-580-01Glimepiride100 in 1 BOTTLETABLET10012
65862-580-05Glimepiride500 in 1 BOTTLETABLET50012
65862-580-99Glimepiride1000 in 1 BOTTLETABLET100012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]3
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]3
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35GLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-580GLIMEPIRIDE TABLET [AUROBINDO PHARMA LIMITED]10Current NDC, Legacy NDC, 3 package rows20231103_28eefc95-d92e-4555-b6c5-2933860b0610.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN28eefc95-d92e-4555-b6c5-2933860b061012
199246glimepiride 2 MG Oral TabletPSN28eefc95-d92e-4555-b6c5-2933860b061012
199247glimepiride 4 MG Oral TabletPSN28eefc95-d92e-4555-b6c5-2933860b061012
199245glimepiride 1 MG Oral TabletSCD28eefc95-d92e-4555-b6c5-2933860b061012
199246glimepiride 2 MG Oral TabletSCD28eefc95-d92e-4555-b6c5-2933860b061012
199247glimepiride 4 MG Oral TabletSCD28eefc95-d92e-4555-b6c5-2933860b061012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
65862-580-49658620580494000 TABLET in 1 BAG (65862-580-49)4000 tablet29-JUN-12Current