FDA.reportPublic FDA data

Glimepiride

Product NDC
0378-4012
11-digit product format
003784012
Labeler code
0378
Product ID
0378-4012_ce446aec-73b0-46a4-90a2-d4dea357ebfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077624
Marketing category
ANDA
Marketing start
2006-03-01
Marketing end
2020-05-31
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0378-4012DDiscontinued by firm2026-07-31
excluded packagepackage0378-40120378-4012-01DDiscontinued 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
A077624-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORAL2005-11-28
A077624-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORAL2005-11-28
A077624-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORAL2005-11-28

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 22:54:322026-06A077624-001GLIMEPIRIDE1MGTABLET / ORAL2005-11-28a50c72e98297…
2026-08-01 22:54:322026-06A077624-002GLIMEPIRIDE2MGTABLET / ORAL2005-11-28a50c72e98297…
2026-08-01 22:54:322026-06A077624-003GLIMEPIRIDE4MGTABLET / ORAL2005-11-28a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4012-01EA - Each0378-4012b0e6d2c4-3fb4-4e8d-9021-ba9e2b360ca812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KGLIMEPIRIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGLIMEPIRIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [MYLAN INSTITUTIONAL INC.]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [MYLAN INSTITUTIONAL INC.]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KGLIMEPIRIDE TABLET [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [MYLAN INSTITUTIONAL INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [MYLAN INSTITUTIONAL INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGLIMEPIRIDE TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [MYLAN INSTITUTIONAL INC.]2