FDA.reportPublic FDA data

AMARYL

Product NDC
0039-0223
Requested package NDC
0039-0223-10
11-digit product format
000390223
Labeler code
0039
Product ID
0039-0223_f54571bb-4a69-4326-aad3-96b1b7198b6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA020496
Marketing category
NDA
Marketing start
2009-06-18
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0039-02230039-0223-10DDiscontinued by firm2026-07-31

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
N020496-001AMARYLGLIMEPIRIDE1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30
N020496-002AMARYLGLIMEPIRIDE2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30
N020496-003AMARYLGLIMEPIRIDE4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30

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 22:54:322026-06N020496-001AMARYL1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30a50c72e98297…
2026-08-01 22:54:322026-06N020496-002AMARYL2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30a50c72e98297…
2026-08-01 22:54:322026-06N020496-003AMARYL4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0039-0223-10EA - Each0039-0223c3eb05a7-5c55-48f0-ac91-b22a174aaf2b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
glimepirideACTIVE INGREDIENT6KY687524KAMARYL (GLIMEPIRIDE) TABLET [SANOFI-AVENTIS U.S. LLC]11
glimepirideACTIVE MOIETY6KY687524KAMARYL (GLIMEPIRIDE) TABLET [SANOFI-AVENTIS U.S. LLC]11
aluminum oxideINACTIVE INGREDIENTLMI26O6933AMARYL (GLIMEPIRIDE) TABLET [SANOFI-AVENTIS U.S. LLC]11
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAMARYL (GLIMEPIRIDE) TABLET [SANOFI-AVENTIS U.S. LLC]11
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKAMARYL (GLIMEPIRIDE) TABLET [SANOFI-AVENTIS U.S. LLC]11
ferric oxide redINACTIVE INGREDIENT1K09F3G675AMARYL (GLIMEPIRIDE) TABLET [SANOFI-AVENTIS U.S. LLC]11
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTAMARYL (GLIMEPIRIDE) TABLET [SANOFI-AVENTIS U.S. LLC]11
lactoseINACTIVE INGREDIENTJ2B2A4N98GAMARYL (GLIMEPIRIDE) TABLET [SANOFI-AVENTIS U.S. LLC]11
magnesium stearateINACTIVE INGREDIENT70097M6I30AMARYL (GLIMEPIRIDE) TABLET [SANOFI-AVENTIS U.S. LLC]11
povidonesINACTIVE INGREDIENTFZ989GH94EAMARYL (GLIMEPIRIDE) TABLET [SANOFI-AVENTIS U.S. LLC]11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0039-0223-1000039022310100 TABLET in 1 BOTTLE (0039-0223-10) 100 tablet2009-06-180000-00-00NoNoCurrent