FDA.reportPublic FDA data

Indapamide

Product NDC
62559-510
11-digit product format
625590510
Labeler code
62559
Product ID
62559-510_e31f26fd-292b-472f-a3e3-a97c3ccb9adc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indapamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA074299
Marketing category
ANDA
Marketing start
2017-04-24
Substance
INDAPAMIDE
Active strength
1.25 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Indapamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDAPAMIDE1.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF089I0511L
Rxcui197815, 197816

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2bda0d04-c82b-7786-6ed9-2a416b849e7aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-510-01Indapamide100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-510-01EA - Each62559-510ab93f59d-6ccc-46b2-bda2-993bd6e8983a12017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-510INDAPAMIDE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20210402_deb83f97-6c61-4a09-bed6-18dcf1183405.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197815indapamide 1.25 MG Oral TabletPSN365d26ea-d02d-4fcf-9c99-54c251ef0483104
197815indapamide 1.25 MG Oral TabletSCD365d26ea-d02d-4fcf-9c99-54c251ef0483104
197815indapamide 1.25 MG Oral TabletPSN8a16fc49-7a36-4873-9652-194ebb0bac68101
197815indapamide 1.25 MG Oral TabletSCD8a16fc49-7a36-4873-9652-194ebb0bac68101
197815indapamide 1.25 MG Oral TabletPSN71feffd5-4056-2b53-e053-2995a90a5b739
197816indapamide 2.5 MG Oral TabletPSN71feffd5-4056-2b53-e053-2995a90a5b739
197815indapamide 1.25 MG Oral TabletSCD71feffd5-4056-2b53-e053-2995a90a5b739
197816indapamide 2.5 MG Oral TabletSCD71feffd5-4056-2b53-e053-2995a90a5b739
197816indapamide (as indapamide hemihydrate) 2.5 MG Oral TabletSY71feffd5-4056-2b53-e053-2995a90a5b739
197815indapamide 1.25 MG Oral TabletPSN962b20df-88ff-4ab7-a900-135adb6c1d746
197815indapamide 1.25 MG Oral TabletSCD962b20df-88ff-4ab7-a900-135adb6c1d746
197815indapamide 1.25 MG Oral TabletPSNdeb83f97-6c61-4a09-bed6-18dcf11834054
197816indapamide 2.5 MG Oral TabletPSNdeb83f97-6c61-4a09-bed6-18dcf11834054
197815indapamide 1.25 MG Oral TabletSCDdeb83f97-6c61-4a09-bed6-18dcf11834054
197816indapamide 2.5 MG Oral TabletSCDdeb83f97-6c61-4a09-bed6-18dcf11834054
197816indapamide (as indapamide hemihydrate) 2.5 MG Oral TabletSYdeb83f97-6c61-4a09-bed6-18dcf11834054
197815indapamide 1.25 MG Oral TabletPSN7fe643f7-a1df-4e9a-9d45-f20b8512a04e1
197815indapamide 1.25 MG Oral TabletSCD7fe643f7-a1df-4e9a-9d45-f20b8512a04e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-510-0162559051001100 TABLET, FILM COATED in 1 BOTTLE (62559-510-01) 2017-04-240000-00-00NoNoCurrent