FDA.reportPublic FDA data

Glimepiride

Product NDC
10544-219
11-digit product format
105440219
Labeler code
10544
Product ID
10544-219_10797255-7883-4f66-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA077091
Marketing category
ANDA
Marketing start
2013-10-08
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct10544-219IInactivated by FDA2026-07-31
excluded packagepackage10544-21910544-219-30IInactivated 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
A077091-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALABRS2005-10-06
A077091-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2005-10-06
A077091-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2005-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077091-001AB
A077091-002AB
A077091-003AB

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 22:54:322026-06A077091-001GLIMEPIRIDE1MGTABLET / ORALABRS2005-10-06a50c72e98297…
2026-08-01 22:54:322026-06A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-06a50c72e98297…
2026-08-01 22:54:322026-06A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077091-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077091-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077091-003AB1a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDECardinal Health 107, LLCcc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa2026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDENuCare Pharmaceuticals,Inc.bf8e5993-5ee7-d26d-e053-2a95a90ae5df2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEAvPAK93f1e064-fcbd-e8fd-e053-2995a90a5dbb2026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDENorthwind Health Company, LLCf3184cd3-df99-db32-e053-2995a90aa5732026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDENorthwind Health Company, LLCdae404ac-881a-14d8-e053-2995a90acd412026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.101cdc41-2131-4425-b550-6a0a60b5f4a42025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.657f1b51-2f82-44f6-a23d-97f4b34b3c452025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEAmerican Health Packaging0003458f-352a-46fa-9d99-230daa76ae292024-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEProficient Rx LP1f102e4c-1954-4f17-8c60-4dad79f25a252024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDENuCare Pharmaceuticals,Inc.abc187f1-8645-23e9-e053-2a95a90a64a72024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEA-S Medication Solutionsbe772fca-1579-4fba-a4b7-04b970d09e452023-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEA-S Medication Solutions0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b2023-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEA-S Medication Solutionsa9461830-1c4f-4bc4-b622-1c44112a76b92023-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEA-S Medication Solutionsdef20e38-01f7-4ead-beb6-3dc11062a3422023-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEBryant Ranch Prepackebb9f080-b11d-5d18-36f0-627107e7fbcd2020-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEDr. Reddy's Laboratories Limited07ad4366-4b21-f633-49f3-c2b35f88168d2019-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091

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
10544-219-302020-01-31C16284748780-19d75b9d0-b2e1-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
10544-219-30Glimepiride30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-219-30EA - Each10544-21938064de4-b06b-4704-9396-c6d09c38c93112015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-219GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150304_e2ed9eeb-e67d-485f-86cb-eb9061bd9d96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNe2ed9eeb-e67d-485f-86cb-eb9061bd9d962
199247glimepiride 4 MG Oral TabletPSNe2ed9eeb-e67d-485f-86cb-eb9061bd9d962
199246glimepiride 2 MG Oral TabletSCDe2ed9eeb-e67d-485f-86cb-eb9061bd9d962
199247glimepiride 4 MG Oral TabletSCDe2ed9eeb-e67d-485f-86cb-eb9061bd9d962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-219-301054402193030 in 1 BOTTLEHistorical