FDA.reportPublic FDA data

Glimepiride

Product NDC
68001-178
11-digit product format
680010178
Labeler code
68001
Product ID
68001-178_eff41a95-d73d-ed0a-e053-2995a90acfc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078181
Marketing category
ANDA
Marketing start
2014-02-26
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68001-178DDiscontinued by firm2026-07-31
excluded packagepackage68001-17868001-178-00DDiscontinued by firm2026-07-31
excluded packagepackage68001-17868001-178-03DDiscontinued 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
A078181-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2007-08-23
A078181-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2007-08-23
A078181-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2007-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078181-001AB
A078181-002AB
A078181-003AB

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 22:54:322026-06A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23a50c72e98297…
2026-08-01 22:54:322026-06A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23a50c72e98297…
2026-08-01 22:54:322026-06A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078181-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078181-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078181-003AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEBryant Ranch Prepack9e863f84-d6f2-4d61-8250-774569e843532026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.58c4261e-e98f-4280-9562-2800956dff142026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1b3c7d74-f80b-4fb1-8dca-66880af5d3fc2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDENorthwind Health Company, LLC3e81a39a-30bb-4d6d-82e1-17d7134365be2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDENorthwind Health Company, LLCf2f2d6da-eb40-4290-e053-2a95a90a6ca02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEAccord Healthcare Inc9b74fbac-9e04-4927-9981-1e3dace89c6d2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LPbeb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LP5a5747ea-cded-49ed-8807-dd3e2a1159e02022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LP68cb4fcd-5bc3-4f53-9085-86df6a4246d62022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-178-00EA - Each68001-178ee560ea0-177c-40c8-b3c8-002f352992d312014-05-02
68001-178-03EA - Each68001-17865e5f814-dbf0-426b-a0ab-d031e3cc6b4c12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
glimepirideACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
glimepirideACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
ferric oxide redINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-178GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]13Legacy NDC20240223_d162c78f-d176-4150-8dda-2c4a5d215014.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-178-0068001017800100 TABLET in 1 BOTTLE (68001-178-00) 100 tablet2014-02-260000-00-00NoNoCurrent
68001-178-0368001017803500 TABLET in 1 BOTTLE (68001-178-03) 500 tablet2014-02-260000-00-00NoNoCurrent