VANCOMYCIN HYDROCHLORIDE

Product NDC
0121-0867
11-digit product format
001210867
Labeler code
0121
Product ID
0121-0867_46c61b28-1b3a-4f06-bcba-bf1fba0a6287
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VANCOMYCIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
PAI Holdings, LLC
Application
ANDA210729
Marketing category
ANDA
Marketing start
2019-07-25
Marketing end
0000-00-00
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
125 mg/1
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0867-20EA - Each0121-0867a5d2f528-b260-4d10-98a0-8adc5011f3bb12019-09-05
0121-0867-50EA - Each0121-086715719040-3264-465b-81d3-6fbcf3c86efc12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0867VANCOMYCIN HYDROCHLORIDE CAPSULE [PAI HOLDINGS, LLC DBA PAI PHARMA]13Legacy NDC20250316_8eacc01c-5ce6-1869-e053-2a95a90a57ce.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0867-20001210867202 BLISTER PACK in 1 CARTON (0121-0867-20) > 10 CAPSULE in 1 BLISTER PACK2 blister pack2019-07-250000-00-00NoNoCurrent
0121-0867-500012108675050 CAPSULE in 1 BOTTLE (0121-0867-50) 50 capsule2020-03-100000-00-00NoNoCurrent