FDA.reportPublic FDA data

Glimepiride

Product NDC
53217-250
11-digit product format
532170250
Labeler code
53217
Product ID
53217-250_cd9c6208-53c4-46c5-9009-486ddd92d895
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078181
Marketing category
ANDA
Marketing start
2007-08-23
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53217-250IInactivated by FDA2026-07-31
excluded packagepackage53217-25053217-250-30IInactivated by FDA2026-07-31
excluded packagepackage53217-25053217-250-60IInactivated by FDA2026-07-31
excluded packagepackage53217-25053217-250-90IInactivated by FDA2026-07-31
excluded packagepackage53217-25053217-250-99IInactivated 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
A078181-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2007-08-23
A078181-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2007-08-23
A078181-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2007-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078181-001AB
A078181-002AB
A078181-003AB

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 22:54:322026-06A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23a50c72e98297…
2026-08-01 22:54:322026-06A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23a50c72e98297…
2026-08-01 22:54:322026-06A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078181-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078181-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078181-003AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEBryant Ranch Prepack9e863f84-d6f2-4d61-8250-774569e843532026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.58c4261e-e98f-4280-9562-2800956dff142026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1b3c7d74-f80b-4fb1-8dca-66880af5d3fc2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDENorthwind Health Company, LLC3e81a39a-30bb-4d6d-82e1-17d7134365be2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDENorthwind Health Company, LLCf2f2d6da-eb40-4290-e053-2a95a90a6ca02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEAccord Healthcare Inc9b74fbac-9e04-4927-9981-1e3dace89c6d2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LPbeb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LP5a5747ea-cded-49ed-8807-dd3e2a1159e02022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LP68cb4fcd-5bc3-4f53-9085-86df6a4246d62022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181

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
53217-250-302020-01-31C16284748780-19d75b9d0-9d0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
53217-250-602020-01-31C16284748780-19d75b9d0-9d0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
53217-250-902020-01-31C16284748780-19d75b9d0-9d0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
53217-250-992020-01-31C16284748780-19d75b9d0-9d0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-250-30Glimepiride30 in 1 BOTTLETABLET301
53217-250-60Glimepiride60 in 1 BOTTLETABLET601
53217-250-90Glimepiride90 in 1 BOTTLETABLET901
53217-250-99Glimepiride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-250-30EA - Each53217-2507f9af054-ec46-4e83-b639-0bfcd49f662112016-12-07
53217-250-60EA - Each53217-250128509b1-da53-40e2-9410-fd454ad52d0912016-12-07
53217-250-90EA - Each53217-250bf65f10c-acb5-4a06-b106-5fdefa1dea4912016-12-07
53217-250-99EA - Each53217-2506cc6206a-6c50-45f1-8450-cf0309b7adbe12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-250GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20161202_feeb6508-bad3-428d-8a76-ddc55793b109.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNfeeb6508-bad3-428d-8a76-ddc55793b1091
199246glimepiride 2 MG Oral TabletSCDfeeb6508-bad3-428d-8a76-ddc55793b1091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-250-305321702503030 in 1 BOTTLEHistorical
53217-250-605321702506060 in 1 BOTTLEHistorical
53217-250-905321702509090 in 1 BOTTLEHistorical
53217-250-9953217025099180 in 1 BOTTLEHistorical