Maxitrol

Product NDC
0998-0630
11-digit product format
009980630
Labeler code
0998
Product ID
0998-0630_03cfa73d-29e8-499c-9ac2-79bcbaa222e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA050023
Marketing category
NDA
Marketing start
1964-11-15
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength
4 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0998-0630-062024-05-02C16284748780-1e4f33bdf-a11b-d8a0-e053-dadaa90a6e4e277ff310-b7dc-43b6-8a16-885b58882bc0
0998-0630-062022-07-29C16284748780-1e4f33bdf-a11b-d8a0-e053-dadaa90a6e4e277ff310-b7dc-43b6-8a16-885b58882bc0

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0998-0630-06ML - Milliliter0998-0630c6c36128-f66e-43db-85f4-e5ec0bd415c812012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0998-0630-06009980630065 mL in 1 BOTTLE, PLASTIC (0998-0630-06) 5 ml1964-11-150000-00-00NoNoCurrent