FDA.reportPublic FDA data

Glimepiride

Product NDC
50090-7406
11-digit product format
500907406
Labeler code
50090
Product ID
50090-7406_e372bb60-62d3-432c-ae33-9343c84be191
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202112
Marketing category
ANDA
Marketing start
2023-07-31
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

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 Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199247

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
50090-7406-0Glimepiride30 in 1 BOTTLETABLET303
50090-7406-1Glimepiride100 in 1 BOTTLETABLET1003
50090-7406-2Glimepiride60 in 1 BOTTLETABLET603
50090-7406-3Glimepiride90 in 1 BOTTLETABLET903
50090-7406-4Glimepiride180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7406-0EA - Each50090-74062f61a8d8-6261-4b86-a0d5-e780a2e1ac7a12024-12-10
50090-7406-1EA - Each50090-74068c17d3a2-58e2-4521-8f73-9c0079f45c0f12024-12-10
50090-7406-2EA - Each50090-7406e168ba01-bc43-4728-9fb2-01eabb2c2a5e12024-12-10
50090-7406-3EA - Each50090-7406ef70b145-eb95-48a1-8253-5b45ec9f882812024-12-10
50090-7406-4EA - Each50090-7406f50e9cc8-16af-4ef9-8432-39cda6bcaa4f12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7406GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 5 package rows20241027_79ee7533-f75d-4c49-b396-b339654f5c44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN79ee7533-f75d-4c49-b396-b339654f5c443
199247glimepiride 4 MG Oral TabletSCD79ee7533-f75d-4c49-b396-b339654f5c443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7406-05009074060030 TABLET in 1 BOTTLE (50090-7406-0) 30 tablet2024-10-24NoNoHistorical
50090-7406-150090740601100 TABLET in 1 BOTTLE (50090-7406-1) 100 tablet2024-10-24NoNoHistorical
50090-7406-25009074060260 TABLET in 1 BOTTLE (50090-7406-2) 60 tablet2024-10-24NoNoHistorical
50090-7406-35009074060390 TABLET in 1 BOTTLE (50090-7406-3) 90 tablet2024-10-24NoNoHistorical
50090-7406-450090740604180 TABLET in 1 BOTTLE (50090-7406-4) 180 tablet2024-10-24NoNoHistorical