FDA.reportPublic FDA data

Glimepiride

Product NDC
68001-584
11-digit product format
680010584
Labeler code
68001
Product ID
68001-584_39526e66-ce21-103e-e063-6294a90a5967
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA091220
Marketing category
ANDA
Marketing start
2023-09-01
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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29a50c72e98297…
2026-08-01 22:54:322026-06A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29a50c72e98297…
2026-08-01 22:54:322026-06A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-29a50c72e98297…
2026-08-01 22:54:322026-06A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29a50c72e98297…
2026-08-01 22:54:322026-06A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-29a50c72e98297…
2026-08-01 22:54:322026-06A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091220-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091220-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091220-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A091220-006AB1a50c72e98297…

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 · 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
ndc (product): 68001-584
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
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

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 · 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
a01b0466-13f5-4c47-ae55-c5f1527d9414Available 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
68001-584-00Glimepiride100 in 1 BOTTLETABLET1003
68001-584-03Glimepiride500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-584-00EA - Each68001-584a722e8e6-3423-4020-a700-6de78533fbea12023-07-06
68001-584-03EA - Each68001-584ec1c64cd-13a0-45dc-923d-fd7d7e387ee812023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-584GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]2Current NDC, 2 package rows20230901_a01b0466-13f5-4c47-ae55-c5f1527d9414.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSNa01b0466-13f5-4c47-ae55-c5f1527d94143
199246glimepiride 2 MG Oral TabletPSNa01b0466-13f5-4c47-ae55-c5f1527d94143
199247glimepiride 4 MG Oral TabletPSNa01b0466-13f5-4c47-ae55-c5f1527d94143
199245glimepiride 1 MG Oral TabletSCDa01b0466-13f5-4c47-ae55-c5f1527d94143
199246glimepiride 2 MG Oral TabletSCDa01b0466-13f5-4c47-ae55-c5f1527d94143
199247glimepiride 4 MG Oral TabletSCDa01b0466-13f5-4c47-ae55-c5f1527d94143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-584-0068001058400100 TABLET in 1 BOTTLE (68001-584-00) 100 tablet2023-09-01NoNoCurrent
68001-584-0368001058403500 TABLET in 1 BOTTLE (68001-584-03) 500 tablet2023-09-01NoNoCurrent