tobramycin and dexamethasone

Product NDC
69238-1373
11-digit product format
692381373
Labeler code
69238
Product ID
69238-1373_47f5be2a-e1d6-46e1-9122-2a17d3f4051b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tobramycin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA212991
Marketing category
ANDA
Marketing start
2021-07-17
Marketing end
0000-00-00
Substance
DEXAMETHASONE; TOBRAMYCIN
Active strength
1 mg/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1373-2ML - Milliliter69238-1373f342339d-d15d-4a3b-9e62-6dc0f901353012021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1373TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC]12Legacy NDC20240815_2a7eea7d-b82d-481a-a83d-96fe21d21cd2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1373-2692381373021 BOTTLE, PLASTIC in 1 CARTON (69238-1373-2) > 2.5 mL in 1 BOTTLE, PLASTIC2021-07-170000-00-00NoNoCurrent