FDA.reportPublic FDA data

Glimepiride

Product NDC
43547-394
11-digit product format
435470394
Labeler code
43547
Product ID
43547-394_95a5568d-751c-4497-b70c-5cc358bbb2af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA077370
Marketing category
ANDA
Marketing start
2017-01-30
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077370-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2005-12-23
A077370-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2005-12-23
A077370-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2005-12-23
A077370-004GLIMEPIRIDEGLIMEPIRIDE8MGTABLET / ORALAB2005-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077370-001AB
A077370-002AB
A077370-003AB
A077370-004AB

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 22:54:322026-06A077370-001GLIMEPIRIDE1MGTABLET / ORALAB2005-12-23a50c72e98297…
2026-08-01 22:54:322026-06A077370-002GLIMEPIRIDE2MGTABLET / ORALAB2005-12-23a50c72e98297…
2026-08-01 22:54:322026-06A077370-003GLIMEPIRIDE4MGTABLET / ORALAB2005-12-23a50c72e98297…
2026-08-01 22:54:322026-06A077370-004GLIMEPIRIDE8MGTABLET / ORALAB2005-12-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077370-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077370-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077370-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A077370-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDESolco Healthcare U.S., LLC86acdd9e-8637-43e4-8bf7-b3a123b871b82021-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077370
application number: ANDA077370
ndc (product): 43547-394

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
86acdd9e-8637-43e4-8bf7-b3a123b871b8Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43547-394-102020-02-25C16284748780-19d75b9d0-54fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride tablets USP safely and effectively. See full prescribing information for glimepiride tablets USP. Glimepiride Tablets USP, for oral use Initial U.S. Approval: 1995
43547-394-502020-02-25C16284748780-19d75b9d0-54fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride tablets USP safely and effectively. See full prescribing information for glimepiride tablets USP. Glimepiride Tablets USP, for oral use Initial U.S. Approval: 1995
43547-394-102020-01-31C16284748780-19d75b9d0-54fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride tablets USP safely and effectively. See full prescribing information for glimepiride tablets USP. Glimepiride Tablets USP, for oral use Initial U.S. Approval: 1995
43547-394-502020-01-31C16284748780-19d75b9d0-54fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride tablets USP safely and effectively. See full prescribing information for glimepiride tablets USP. Glimepiride Tablets USP, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-394-10Glimepiride100 in 1 BOTTLE, PLASTICTABLET1004
43547-394-50Glimepiride500 in 1 BOTTLE, PLASTICTABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-394-10EA - Each43547-3944c4657f3-e600-4370-ba94-e1a861c8ec1e12017-05-03
43547-394-50EA - Each43547-394ec0b68c3-7d2c-4615-87d9-8a34b215e1b712017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-394GLIMEPIRIDE TABLET [SOLCO HEALTHCARE U.S., LLC]4Current NDC, Legacy NDC, 2 package rows20200824_86acdd9e-8637-43e4-8bf7-b3a123b871b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN86acdd9e-8637-43e4-8bf7-b3a123b871b84
199246glimepiride 2 MG Oral TabletPSN86acdd9e-8637-43e4-8bf7-b3a123b871b84
199247glimepiride 4 MG Oral TabletPSN86acdd9e-8637-43e4-8bf7-b3a123b871b84
199245glimepiride 1 MG Oral TabletSCD86acdd9e-8637-43e4-8bf7-b3a123b871b84
199246glimepiride 2 MG Oral TabletSCD86acdd9e-8637-43e4-8bf7-b3a123b871b84
199247glimepiride 4 MG Oral TabletSCD86acdd9e-8637-43e4-8bf7-b3a123b871b84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-394-1043547039410100 TABLET in 1 BOTTLE, PLASTIC (43547-394-10) 100 tablet2017-01-300000-00-00NoNoCurrent
43547-394-5043547039450500 TABLET in 1 BOTTLE, PLASTIC (43547-394-50) 500 tablet2017-01-300000-00-00NoNoCurrent