Isoniazid

Product NDC
0527-1109
11-digit product format
005271109
Labeler code
0527
Product ID
0527-1109_a13b95af-4c61-4f51-ad02-7e6d470756e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL; ORAL
Labeler
Lannett Company, Inc.
Application
ANDA089776
Marketing category
ANDA
Marketing start
2013-10-10
Marketing end
0000-00-00
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [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
0527-1109-01EA - Each0527-1109cc7da354-7ce0-44d8-89aa-c57c529587b912013-12-02
0527-1109-10EA - Each0527-1109ccc5ae0a-a90e-495f-a3b7-bd5f88d0910312013-12-02
0527-1109-30EA - Each0527-110950350557-8c45-4770-b16f-d055b613a03e12013-12-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1109-0100527110901100 TABLET in 1 BOTTLE (0527-1109-01) 100 tablet2013-10-100000-00-00NoNoCurrent
0527-1109-10005271109101000 TABLET in 1 BOTTLE (0527-1109-10) 1000 tablet2013-10-100000-00-00NoNoCurrent
0527-1109-300052711093030 TABLET in 1 BOTTLE (0527-1109-30) 30 tablet2013-10-100000-00-00NoNoCurrent