FDA.reportPublic FDA data

Glimepiride

Product NDC
0440-6565
11-digit product format
004406565
Labeler code
0440
Product ID
0440-6565_e1dc8450-aa93-42af-8aba-aa447493bf17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA077911
Marketing category
ANDA
Marketing start
2012-01-01
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0440-6565IInactivated by FDA2026-07-31
excluded packagepackage0440-65650440-6565-01IInactivated by FDA2026-07-31

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
A077911-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2009-09-22
A077911-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2009-09-22
A077911-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2009-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077911-001AB
A077911-002AB
A077911-003AB

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 22:54:322026-06A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22a50c72e98297…
2026-08-01 22:54:322026-06A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22a50c72e98297…
2026-08-01 22:54:322026-06A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077911-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077911-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077911-003AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.647a146c-c752-4589-8619-aed5c720ca542026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.ed7a3a8e-97dd-4a5a-9497-001acfd2f1f02026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.f4ffb19e-6d65-49fd-83ce-514d38d9d97c2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.11ae3189-6139-4470-95d5-72abc0f5b0d02025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.2794f86b-d521-414b-8154-5dd1e25196532025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEGolden State Medical Supply, Inc.4f83e203-c102-47fa-bb8e-4fc5541e0d6f2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDECarlsbad Technology, Inc.72d88c6d-2f0a-4bf8-aa7f-1e18117941872024-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEAphena Pharma Solutions - Tennessee, LLC00b9e312-921e-41e6-ad27-0a6ce87f82982019-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-6565-012020-01-31C16284748780-19d75b9cf-f44c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Glimepiride safely and effectively. See full prescribing information for Glimepiride Tablets, USP. Glimepiride Tablets, USP Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-6565-01Glimepiride100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-6565-01EA - Each0440-6565b443c9a8-96a3-4af6-a24b-6a2c9f30020a12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-6565GLIMEPIRIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20160805_8b309577-5461-43eb-bb0b-0a5293ee9392.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSN8b309577-5461-43eb-bb0b-0a5293ee93922
199246glimepiride 2 MG Oral TabletSCD8b309577-5461-43eb-bb0b-0a5293ee93922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-6565-0100440656501100 in 1 BOTTLEHistorical