Indapamide

Product NDC
0378-0080
11-digit product format
003780080
Labeler code
0378
Product ID
0378-0080_a92c5cdc-8cb6-44ad-ae7d-d6f415f1e8c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indapamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074461
Marketing category
ANDA
Marketing start
1996-03-28
Marketing end
0000-00-00
Substance
INDAPAMIDE
Active strength
3 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [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
0378-0080-01EA - Each0378-008016e698d2-6cd8-49af-a124-4f62acd6966212012-07-24
0378-0080-10EA - Each0378-0080a7f4228b-86b1-423d-b660-bea6245a22a712012-07-24
0378-0080-77EA - Each0378-008013b55f32-12e5-4f63-a860-98ad83bff8dd12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0080-0100378008001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0080-01) 1996-03-280000-00-00NoNoCurrent
0378-0080-10003780080101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0080-10) 1996-03-280000-00-00NoNoCurrent
0378-0080-770037800807790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0080-77) 2010-02-160000-00-00NoNoCurrent