Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC
70518-0864
11-digit product format
705180864
Labeler code
70518
Product ID
70518-0864_5ec0e299-23b4-4bef-e053-2991aa0af791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
REMEDYREPACK INC.
Application
ANDA064065
Marketing category
ANDA
Marketing start
2017-11-24
Marketing end
0000-00-00
Substance
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
10 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-0864-02020-05-06C16284748780-19d75b9d0-4294-f424-e053-dadaa90a57ce83f62c30-39c4-432e-a15b-4b47504b1c13
70518-0864-02020-01-31C16284748780-19d75b9d0-4294-f424-e053-dadaa90a57ce83f62c30-39c4-432e-a15b-4b47504b1c13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0864NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REMEDYREPACK INC.]5Legacy NDC20250503_83f62c30-39c4-432e-a15b-4b47504b1c13.zip