FDA.reportPublic FDA data

Glimepiride

Product NDC
60429-920
11-digit product format
604290920
Labeler code
60429
Product ID
60429-920_288c1f6b-3779-3b65-e063-6394a90ae906
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA077911
Marketing category
ANDA
Marketing start
2009-09-22
Substance
GLIMEPIRIDE
Active strength
4 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 · 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
ndc (product): 60429-920
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

Additional Listing Data#

Finished product
Yes
Brand name base
Glimepiride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE4 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
4f83e203-c102-47fa-bb8e-4fc5541e0d6fAvailable 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
60429-920-01Glimepiride100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-920-01EA - Each60429-9207e07d9ce-602e-4afd-ac64-bd33ea43d4ce12017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-920GLIMEPIRIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]6Current NDC, Legacy NDC, 1 package rows20241212_4f83e203-c102-47fa-bb8e-4fc5541e0d6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199246glimepiride 2 MG Oral TabletPSN4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199247glimepiride 4 MG Oral TabletPSN4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199245glimepiride 1 MG Oral TabletSCD4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199246glimepiride 2 MG Oral TabletSCD4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199247glimepiride 4 MG Oral TabletSCD4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199247glimepiride 4 MG Oral TabletPSN00b9e312-921e-41e6-ad27-0a6ce87f82981
199247glimepiride 4 MG Oral TabletSCD00b9e312-921e-41e6-ad27-0a6ce87f82981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-920-0160429092001100 TABLET in 1 BOTTLE (60429-920-01) 100 tablet2016-12-210000-00-00NoNoCurrent